Fastenau et al.

BMC Public Health 2014, 14:788

http://www.biomedcentral.com/1471-2458/14/788

STUDY PROTOCOL Open Access

Efficacy of a physical exercise training

programme COPD in primary care: study protocol
of a randomized controlled trial
Annemieke Fastenau1*, Jean WM Muris1, Rob A de Bie2,3, Erik JM Hendriks4, Guus M Asijee1,5,
Emmylou Beekman2,3, Rik Gosselink6 and Onno CP van Schayck1

Abstract
Background: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant
extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been
shown to be very effective in counteracting these consequences in patients with more advanced COPD. However,
limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate
COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily
physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the
efficacy of a physical exercise training programme in patients with mild to moderate COPD.
Methods/design: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to
moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be
randomized to an intervention or control group. The intervention group receives a 4-month physical exercise
training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing
exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e.
advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of
which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at
4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength,
physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and
patients’ perceived effectiveness. Follow-up measurement will take place at 6 months after baseline.
Discussion: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme
in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial
may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation
programme.
Trial registration: The Netherlands National Trial Register NTR1471.
Keywords: Chronic obstructive pulmonary disease, Exercise training, Physical activity, Primary care, Randomized
controlled trial

* Correspondence: annemieke.fastenau@maastrichtuniversity.nl
1
Department of Family Medicine, CAPHRI School for Public Health and
Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The
Netherlands
Full list of author information is available at the end of the article

© 2014 Fastenau et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited.
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Background was multifaceted (i.e. involved more than exercise therapy

In patients with chronic obstructive pulmonary disease alone) [22]. To our knowledge hardly any data are avail-
(COPD), disease severity and prognosis are not only de- able on the efficacy of physical exercise training pro-
termined by lung function impairment, but are also re- grammes in patients with mild to moderate COPD that
lated to extra-pulmonary consequences of COPD such are recruited and treated solely in primary care.
as muscle weakness and exercise intolerance [1-3]. The
exercise training component of pulmonary rehabilitation Relevance
(PR) has been shown to be very effective in improving From a patients’ perspective, an increase in exercise
exercise capacity, dyspnoea and quality of life [4]. As a capacity and daily physical activity during the early
result, for patients with moderate to very severe COPD stage of the disease could be beneficial in order to stop
and breathlessness (MRC dyspnoea score >2) exercise the downward spiral of symptom-induced inactivity,
training is recommended as part of PR in national and deconditioning, muscle weakness, the fear of movement
international guidelines [1,5]. Another extra-pulmonary and reduced quality of life. Since behavioural research
feature of COPD is the decline in daily physical activity suggests that modifying behavioural patterns and cop-
(PA) [6]. Only a few trials have investigated the effect of ing styles takes time to be effective, regular exercise
exercise training on changes in daily physical activity should be started early in the course of the disease for
[7-11]. These studies showed contradictory results, ran- maximal effect [25]. It seems advantageous to initiate
ging from significant improvements in PA [8,9] after exercise training when the symptoms of dyspnoea and
exercise training, to small or moderate effects [7,10] and deconditioning are not very pronounced. Furthermore,
no effects at all [11]. Overall, current data indicate that it is proposed that in patients with a relatively preserved
exercise training results in a significant but small effect on lung function, the physiological reserve for improve-
PA and that larger randomized controlled trials (RCT’s) ment is much larger than in patients with (very) severe
are needed in this area [12]. disease [22].
A differentiation should be made in the improvement of Treatment of COPD at an early stage could also lessen
exercise capacity on the one hand and improvement of the burden of disease for society [26]. COPD is one of
daily physical activity on the other. Improvement in exer- the leading causes of morbidity and mortality worldwide
cise capacity fulfils the short-term goal of reducing breath- and imparts a substantial economic burden [27]. COPD-
lessness and fatigue [11], improving muscle strength and related illness costs are disproportionately distributed,
thus lowers the barriers to be physically more active [10]. with 10% of the patients (mostly patients in the more se-
Regular physical activity in COPD patients has important vere stages of the disease) accounting for 73% of the total
long-term health-related benefits, like a lower risk of costs, in which hospitalization is the largest contributor
COPD related hospital admissions and decreased mor- [27]. An exercise training programme in primary care will
tality [13]. Furthermore, low physical activity has been be a relatively cheap and an easily accessible intervention
associated with systemic inflammation, cardiac dysfunc- for more patients than an expensive hospital-based re-
tion and lung function decline [13,14]. habilitation programme [28]. Although longitudinal stud-
All abovementioned studies were performed in a clinical ies are lacking, it is suggested that early recognition of
or rehabilitation setting in COPD patients in more ad- progression of exercise impairment especially in less ad-
vanced GOLD stages [4]. However, patients with moderate vanced COPD patients is relevant to prevent further de-
COPD also have impairments in exercise capacity, respira- terioration of functional capacity [22,29].
tory muscle function, limb muscle force and quality of life
[15-18]. In addition, the level of physical activity is already Current daily care for COPD
decreased in patients with moderate COPD compared to The Practice Guideline COPD of the Dutch College of
healthy control subjects [14,19,20]. Scant information is General Practitioners (NHG standard, 2007) recommends
available on the effects of community-based exercise train- general practitioners (GP’s) advise all patients with COPD
ing programmes in general and even less about their effect to be sufficient physically active [5]. Referral to a physical
on daily activity [9]. Exercise training programmes in pa- exercise training programme in a physiotherapy setting is
tients with moderate to severe COPD, when incorporated advised only in patients with moderate to severe COPD,
in (self)-management or integrated disease management who have impairments in physical functioning due to dys-
programmes in primary care, result in improvements in pnoea. As of 2010, there is a new development in the pri-
health-related quality of life, breathlessness, exercise cap- mary care organization of patients with chronic disease in
acity, muscle strength, daily physical activity, reduced hos- the Netherlands, including COPD. Disease management
pital admissions and hospital days per person [9,21-24]. programmes have regionally been developed by general
Recruitment and assessment was done in the respiratory practitioners in collaboration with other caregivers in
department of general hospitals [9,21] or the intervention primary care. General practitioners and/or the nurse
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practitioner have a central role. Their COPD care entails Methods/design

lung function testing, prescription of pharmacotherapy Study design
and counselling on smoking cessation, inhalation tech- A randomized controlled trial performed in the primary
nique and physical activity. There is the possibility to refer care setting in which the effects of a 4-month physical ex-
patients with mild to moderate COPD to registered physio- ercise training programme for patients with mild to mod-
therapists, experienced in COPD care. The implementation erate COPD will be compared to a control programme.
of this disease management programme for COPD is en- The latter includes advices concerning physical activity ac-
couraged by the reimbursement through so-called chained cording to the Practice Guidelines of the Dutch College of
diagnose-treatment combination (DTC) [29]. Although in General Practitioners [5] and a sham-treatment (ST) in
some regions in the Netherlands these disease manage- physiotherapy practice.
ment programmes for COPD are already implemented and General practice is the primary entrance for patients to
serve as current daily care, no evidence on the effectiveness participate in the trial. If a patient is a potential trial partici-
of these programmes is available. In addition, no data are pant, the GP or nurse practitioner explains to the patient
available on the added value of a physical exercise training that it is important to enhance his physical activity level.
programme compared to advice on increasing daily phys- For professional support to achieve this goal, the patient is
ical activity in usual care. referred to a COPD-certificated physiotherapist. If the pa-
tient is willing to undergo the physiotherapy treatment, he/
she makes an appointment at the physiotherapy practice.
Objectives The physiotherapist will give extensive information about
The primary objective of our study is to evaluate the effi- the study procedures and the patient will have one week to
cacy of a physical exercise training programme (PETP) in consider participation in the trial. If the patient wants to
patients with mild to moderate COPD in the primary care participate, randomization will take place after obtaining
setting on exercise capacity, physical activity, dyspnoea informed consent. Patients of both treatment groups will
and quality of life. The 6 month time point is aimed at be assessed in physiotherapy practice at baseline, at the
gaining more insight into the lasting of the effects. end of the programme (after four months) and six months
The secondary objective is to assess how patient charac- after baseline assessment. The measurements done by the
teristics and baseline burden of disease modify the effect physiotherapist are part of their routine assessments and
of a physical exercise training programme on functional are imbedded in the intake procedures. The results of this
exercise capacity in patients with mild to moderate COPD intake procedure will be the starting point of the treatment.
in primary care. Figure 1 illustrates the flow of the study.

Intake
Motivation
QoL-questionnaires
6MWT
Muscle strength
Physical Activity A A A
S S S
S S S
E E E
CONTROL S S S
S
SHAM-TREATMENT S S
REFERRAL OF I GROUP M M M
COPD PATIENTS N E E E
N N N
CONSIDERA- C T T T
REGISTRATION L
TION TIME
PT U
+
+ S
INFORMED A A A
INTAKE I S S S
CONSENT
O S S S
E PHYSICAL E E
N INTER-
S EXERCISE S S
VENTION S S S
TRAINING
GROUP M M M
E PROGRAMME E E
N N N
T T T

General
Practitioner /
Physiotherapist Patient Researcher Secretary UM Physiotherapist
Nurse
Practitioner

1 week T=0 T=1 T=2

4 months 6 months

Figure 1 Overview of the flow of the study.

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The ethics committee of Maastricht University has ap- not applicable in this study. The participating general
proved the study protocol, procedures and informed con- practitioners, nurse practitioners and physiotherapists and
sent and the trial has been registered at The Netherlands also the patients cannot be blinded to allocation of indi-
National Trial Register NTR1471. viduals to the intervention group or control group. Al-
though patients will be aware of the existence of two
Setting treatment arms, they are not informed about the exact
This multicenter trial is coordinated by the CAPHRI content of the other treatment arm. Also, patients of both
School for Public Health and Primary Care of Maastricht groups will not be in the same physiotherapy setting for
University and conducted in several general practices treatment at the same time. The researcher will be fully
and physiotherapy practices in the southern part of the blinded to the randomization list until the clinical data-
Netherlands. base is unlocked at the end of the trial.

Study population Sample size calculation

Participants for the trial will be recruited from general We performed a pilot study in one physiotherapy setting
practices in Limburg, in the southern part of the in order to get a rough idea of the improvement in six-
Netherlands. There are 614 general practices in this region minute walk distance (6MWD) in this group of patients
covering a population of over 1.000.000 [30]. Statistics after a 4-month physical exercise training programme.
suggest that 1,7% of the Dutch population is likely to have Data of six patients with mild to moderate COPD were
COPD [31]. The population in Limburg is the least physic- collected. Their mean 6MWD was 475 metres with a
ally active population of the Netherlands [32]. standard deviation of 62. These patients increased their
Inclusion will be based on patients with a clinical diagno- 6MWD by a mean of 52 metres. Troosters et al. re-
sis of mild to moderate COPD (post-bronchodilator FEV1/ ported a mean difference in change from baseline of 52
FVC ratio < 0,7 and FEV1 ≥ 50% of predicted); who not metres between the intervention group and control
have a minimum of 30 minutes of physical activity at mod- group, in a study of the short- and longer-term benefits
erate intensity, on at least 5 days per week, according to of 6 months pulmonary rehabilitation [35]. A more re-
the ACSM-recommendation [33]; having a stable situation cent study showed an improvement of 54 metres with a
(no exacerbations in the last 8 weeks) and adequate and standard deviation of 78 metres after a 7 week pulmonary
optimal inhalation technique, are competent enough to rehabilitation programme [11]. Our assumptions for this
understand and speak the Dutch language and having pro- study are that the mean difference in change from baseline
vided written informed consent. According to the Practice between the intervention group and the control group (δ)
Guidelines of the Dutch College of General Practitioners, a is 52 metres (52–0 m), with a standard deviation (σ) of 78
maximal cardiopulmonary exercise test prior to exercise metres [11]. According to the effect size measures for two
training will be conducted by a pulmonologist, cardiologist independent groups this implies a large effect
or a sports medicine physician in COPD patients who suf- size (Cohen’s d = δ/σ = 52/78 = 0.66) [36]. The sample size
fer from cardiopulmonary co morbidities [5,34]. needs to be 36 patients per treatment arm (72 in total),
Patients will be excluded from the trial, when they: whereby α = 0.05 (2 tailed), 80% power and a ratio of con-
already receive or have received a physical exercise training trol to experimental patients of 1:1. This sample size calcu-
programme or rehabilitation therapy in the past year; have lation is done by using the PS power and sample size
had respiratory tract infections within the last 8 weeks; are program of Dupont and Plummer [37,38].
suffering from serious co morbid conditions, which would A total patient number of 102 participants (51 per
interfere with regular exercise training (including severe treatment arm) is needed, based on the abovementioned
orthopaedic, muscular, neurological disorders or cardio- calculation and allowing for dropouts (30%). Previous
vascular conditions) and patients who are expected to be studies showed a drop-out rate varying from 26 to 31%
lost for follow-up (e.g. because of a planned change of resi- [11,35,39,40].
dency or a long holiday break).
Intervention
Randomization and blinding The treatment period is set at four months and consists of
After informed consent is obtained, patients will be ran- either the physical exercise training programme or the
domly assigned to the intervention group or the control sham-treatment. The intervention will be carried out by
group in a 1:1 ratio, with the help of computer generated physiotherapists working in a primary care setting, with
random number tables. Randomization will be performed broad expertise and education in COPD. The treatment
by a centralized and independent person who has a con- protocol is standardised, the Dutch Guideline Physiother-
cealed list. The researcher is not involved in allocation to apy in COPD serves as a framework, and based on indi-
treatment group or setting. Full blinding procedures are vidual problems and possibilities of the patient [41].
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Intervention group (Physical Exercise Training Programme) developed in collaboration with the NHG as part of a
The physical exercise training programme has four main preceding implementation project of physiotherapy for
goals; improvement in exercise capacity, muscle strength, COPD patients in primary care [44].
daily physical activity and breathing technique. The phys- In addition, the patients in the control group will par-
ical training component entails endurance training and/or ticipate in a sham-treatment at the physiotherapy prac-
interval training [41]. Walking speed on the treadmill is tice. This treatment consists of 30 minutes once a week
executed with an intensity of 75% or higher of the results “exercise” training, with ratings of perceived exertion
of the six-minute walk test (6MWT). Ratings of perceived and dyspnoea of 2 or lower on a modified Borg-scale. It
exertion and dyspnoea of five and higher on the modified is unlikely that a physiologic training stimulus will occur
Borg-scale (0–10) are used to tailor exercise intensity [42]. at these levels of exertion. There will be no breathing ex-
Resistance training in addition to endurance or inter- ercises or resistance training. Furthermore, patients will
val training is recommended in all patients, especially be advised to do at least 30 minutes of moderate intense
important in patients with peripheral muscle weakness. physical activities on at least five days a week according
In the absence of any comparative studies it is recom- to the ACSM-recommendation for physical activity [33].
mended to use both upper limb and lower limb resist-
ance weight training at an intensity of at least 60-80% of Outcome measures
the one repetition maximum, 2 to 3 sets of 8–12 repeti- All outcomes will be assessed at baseline (T0), at the
tions are preferable [41]. end of intervention after four months (T1) and at the
Much emphasis is given to the assessment and treat- end of follow-up (T2) at six months.
ment of physical inactivity in daily life. Patients are ad-
vised to increase their total physical activity. Patient and Primary outcome measure
physiotherapist together define a strategy to meet the The primary outcome measure will be the functional ex-
ACSM-recommendation for physical activity, i.e. per- ercise capacity measured by the increase in the six-
forming moderately intense physical activity for 30 mi- minute walk distance (6MWD) at 4 months compared
nutes on at least five days a week [33]. to baseline. The six-minute walk test (6MWT) will be
Breathing exercise is an embracing term for a range of performed in accordance with the ATS Statement:
exercises such as active expiration, slow and deep guidelines for the 6MWT [45], except that a standard
breathing, pursed lips breathing, relaxation therapy, 30-meter corridor will not always be feasible in a pri-
body positions such as forward leaning and diaphrag- mary care physiotherapy practice, but the minimal track
matic breathing [41]. will be 10 meter. The results will be expressed in abso-
The physical exercise training programme will consist of lute values and as percent of the predicted value [46].
two supervised sessions per week in the physiotherapy set- During the walk test, perceived fatigue and dyspnoea will
ting in primary care. These sessions will be with 1–5 pa- be measured on a modified Borg scale ranging from zero
tients at the time and the duration of each session will be (nothing at all) to ten (very, very severe) [47]. Oxygen
60–90 minutes, depending on group size. From an organ- saturation and pulse rate will be measured by a finger
isational and practical point of view it is not feasible to ask pulse oximeter (Onyx 9500) [45].
patients to come to a physical therapy setting more often.
Furthermore, as mentioned before, an important part of Secondary outcome measures
the programme is enhancement of daily physical activity. Isometric handgrip force will be measured with a hy-
So, patients are requested to perform an additional train- draulic handheld dynamometer (Yamar Preston, Jackson
ing session at home, including walking and/or cycling and MI). Peak handgrip force (in Newton) will be assessed at
they have to report these activities weekly to the physio- the dominant side with the elbow at 90 degrees flexion,
therapist. It is our aim to enhance the awareness and with the underarm and wrist in neutral position [48].
responsibility of our patients to change their physical ac- Isometric knee extension and shoulder abduction force
tivity behaviour for the long term and this encompasses will be measured in standardised positions by a hand-
enhancement of self-management and self-efficacy. held dynamometer by means of the break method
[42,49]. Peak torques will be measured at the dominant
Control group (sham-treatment) side according to Andrews et al. [49]. At least three at-
According to the national guidelines of the Dutch College tempts will be performed for all muscle tests.
of General Practitioners (NHG) and the Multidisciplinary Self-reported daily physical activity will be assessed by
Guideline on non-pharmacological treatment of COPD, the brief physical activity assessment tool [50]. Objective
the GP and the nurse practitioner should give advice to daily physical activity will be measured during 3 con-
improve the physical condition [5,43]. Verbal advice will secutive days and nights with an accelerometer-based
be supported by a written brochure. This brochure is activity monitor (Dynaport; McRoberts BV). Data of
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both intensity of movement and duration will be col- Discussion

lected, like steps per day, total active time per day, time This will be one of the first studies to evaluate the efficacy
spent in moderate intense physical activities and vigor- of a physical exercise training programme in patients with
ous activities and physical activity level (PAL). All pa- mild to moderate COPD completely recruited and assessed
tients will be carefully instructed on how the activity in primary care. If the results of this study show that this
monitor should be positioned and they will receive a training programme is effective, this would mean a big step
manual with clear instructions and figures. They will ahead in the follow-up of patients with mild to moderate
also have to fill out a checklist to verify if their day was a COPD. Patients are actively involved in their disease man-
representative one and to indicate any possible hin- agement in an early phase and the intervention can ameli-
drance of the activity monitor. orate further deterioration and influence their prognosis in
The level of dyspnoea will be assessed by the Medical the long term [22]. Exercise training has been shown to
Research Council (MRC) dyspnoea score [51]. Specific positively affect some aspects of health status (exercise
Health Related Quality of Life (HRQL) will be assessed capacity, muscle force, blood pressure, bone mass) [65].
by means of the Clinical COPD Questionnaire (CCQ) Using an active lifestyle is necessary to break out of the
[52,53] and the Chronic Respiratory Questionnaire (CRQ- negative spiral of dyspnoea and deconditioning and is
SR) [54-56]. The global perceived effect (GPE) of the treat- probably essential for a long lasting change in improve-
ment according to the patients will be measured on a GPE ments in daily physical activity. The availability of a phys-
scale [57,58]. ical exercise training programme close to the patient’s
Furthermore, the following baseline characteristics will home most likely improves compliance to the enhanced
be measured, height, weight, Body Mass Index (BMI) physical activity [22]. With this enhanced physical activity
and level of motivation by means of the questionnaire and the benefits of an improved exercise capacity, a patient
(Dutch translation) according to Miller and Rollnick can regain his social contacts [22]. This will give a great
et al. [59-61]. impact of a patient’s quality of life.

Data analysis Bias, confounders and limitations

The descriptive characteristics will be presented quantita- From a methodological point of view, a cluster random-
tively as means (±standard deviation) for continuous vari- ized design would be the most sound design for the
ables and as medians for categorical variables and will be study. The rationale for performing an individually ran-
presented for the total group, as well as for the separate domized trial is that we observed in a pilot study [44],
groups. Unpaired t-tests will be used to compare the ef- that physiotherapists were not very keen to deliver a treat-
fects of the treatment between the intervention group and ment without a proper training programme, although
control group at the end of the physical exercise training hard evidence of efficacy of a physical exercise training
programme (4 months). P-values smaller than 0.05 will be programme COPD was still lacking. Therefore, it would
considered as statistically significant. be impossible to recruit sufficient physiotherapy practices
Group (intervention vs. control) by time (pretest vs. with treating only control patients. We have found a solu-
posttests) repeated measurements analysis of variance tion to this problem by allowing the physiotherapist offer-
(RM ANOVA) will be performed to examine (1) interven- ing the possibility for patients in the control group to
tion main effect, (2) time main effect, and (3) intervention participate in the physical exercise training programme
by time interaction effect on each of the continuous pri- after the study-period, in case the intervention has proven
mary and secondary outcomes. An analysis of covariance to be efficacious. To tackle contamination, we will train
will be done to evaluate the relationship between covari- and instruct the physiotherapists thoroughly in advance of
ates and the dependent variable. The random effect will the study and monitor and instruct them throughout the
also be evaluated, since participants from both arms will intervention period. Physiotherapists can only participate
be nested within the same physiotherapy setting. To evalu- if they are willing to deliver both the intervention treat-
ate which factors predict a positive outcome, i.e. the phys- ment and sham-treatment. Another strategy to minimize
ical exercise training programme is effective, a multiple contamination is that patients of the intervention and
linear regression analysis will be done, using interaction control group will not be in the same physiotherapy set-
terms between predictors and physical exercise. A pre- ting at the same time. So, the physiotherapists can focus
dictor variable will make a significant contribution to pre- their mind on just one treatment at the time.
dicting the outcome when P-value is smaller than 0.05. Both the physiotherapists and the patients are not
The following possible predictors are taken into account, blinded during this study, since they are aware of the
baseline: MRC dyspnoea score, walking distance, periph- treatment procedures. Physiotherapists will conduct the
eral muscle strength, level of daily physical activities and measurements as well as the treatment in patients. Due
compliance with the training programme [62-64]. to practical considerations it is not feasible to perform
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all measurements in many different practice settings by of physiotherapy for COPD patients in primary care in
a single researcher. To assure a high quality and uni- the region to be studied [44]. One of the main objectives
vocal treatment, the participating physiotherapists will was to start up and improve collaboration between gen-
be trained and instructed extensively before the start of eral practitioners, nurse practitioners and physiothera-
the training. Also, throughout the intervention period pists. As a result of the project referral policy of COPD
the physiotherapists will be monitored continuously. patients to physiotherapists in primary care in this re-
The researcher will visit the participating physiotherapy gion improved. In this way, we expect to minimize re-
practices frequently and will have regular contact by cruitment problems.
telephone and email in order to check the compliance Given the evidence of the efficacy of pulmonary rehabili-
with the treatment protocols. tation on functional exercise capacity, dyspnoea and qual-
As the population in Limburg is the least physically ac- ity of life in patients with moderate to severe COPD, there
tive population of the Netherlands, this might influence is now an urgent need to determine whether similar obser-
the external validity of the study. Another limitation is vations apply in the larger group of patients with earlier
that the six-minute walk tests are performed on different disease characteristics [40].
tracks, which will influence the variability. An advantage
of the randomization on patient level instead of phy- Abbreviations
BMI: Body Mass Index; CCQ: Clinical COPD Questionnaire; COPD: Chronic
siotherapy practice level is that patients are assigned to obstructive pulmonary disease; CRQ: Chronic Respiratory Questionnaire;
smaller and longer passages in a non-differential manner DTC: Diagnose-treatment combination; FEV1: Forced expiratory volume in
and an equal distribution of patients from the intervention one second; FVC: Forced vital capacity; GOLD: the Global Initiative for
Chronic Obstructive Lung Disease; GP: General practitioner; GPE: Global
group and control group can be expected per physiother- perceived effect; HRQL: Health Related Quality of Life; MRC: Medical Research
apy practice. Since we are interested in the difference Council; NHG: Dutch College of General Practitioners; PAL: Physical activity
scores (4 or 6 months minus baseline measurement) and level; PETP: Physical exercise training programme; PR: Pulmonary
rehabilitation; RCT: Randomized controlled trial; ST: Sham-treatment;
participants are assessed in the same passage on all occa- 6MWD: Six-minute walk distance; 6MWT: Six-minute walk test.
sions, we think that the variability is acceptable.
Competing Interests
The authors declare that they have no competing interests.
Potential barriers
From the feasibility study of Faulkner et al. it is known Authors’ contributions
that recruitment of patients with moderate COPD for a All authors have made substantial contributions to conception and design,
physical activity intervention in primary care is very dif- and have been involved in drafting the manuscript or revising it critically for
important intellectual content; and have given final approval of the version
ficult [40]. The reported main recruitment issue for to be published.
caregivers in that study was lack of available time to par-
ticipate in research activities [40]. Furthermore, in gen- Acknowledgements
eral practice no objective tool to measure daily physical The funding of this study is provided by the MUMC MOVE programme of
Maastricht University, and an unconditional grant of Boehringer-Ingelheim,
activity is available, only subjective questionnaires. As The Netherlands.
a consequence, general practitioners or practice nurses
might have a lack of information on this topic and will Author details
1
Department of Family Medicine, CAPHRI School for Public Health and
not consider a follow-up strategy, including referral to a Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht, The
physical exercise training programme. Netherlands. 2Department of Epidemiology, CAPHRI School for Public Health
One of the first major symptoms in COPD is exer- and Primary Care, Maastricht University, PO Box 616, 6200 MD Maastricht,
The Netherlands. 3Centre for Evidence Based Physiotherapy, Maastricht
tional breathlessness. To avoid confrontation with this University, PO Box 616, 6200 MD Maastricht, The Netherlands. 4Physical
symptom, patients with COPD are more inclined to therapy practice, Fysiotherapie Maasstaete, Druten, The Netherlands.
5
adapt their lifestyle, for example taking the elevator in- Boehringer Ingelheim, Alkmaar, The Netherlands. 6KU Leuven, Faculty of
Kinesiology and Rehabilitation Sciences, Tervuursevest 101, box 1500, 3001
stead of climbing the stairs. In this way impairments in Leuven, Belgium.
daily life are not noticed by the patient. So, on patients’
level it might be a barrier that patients with only a mild Received: 6 June 2013 Accepted: 23 July 2014
Published: 3 August 2014
airway obstruction and moderate exercise limitation do
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