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PII: S0031-9406(17)30060-3
DOI: http://dx.doi.org/doi:10.1016/j.physio.2016.08.005
Reference: PHYST 981
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Effectiveness of a combined exercise training and home-based
a
Physiotherapy Centre De Oppers, Drachten, The Netherlands
b
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam Medical
*
Corresponding author. Address: De Oppers 3, 9203 GD Drachten, The Netherlands. Tel.: +31 512 515 591.
Abstract
Objective To estimate the effectiveness of a 10-week combined exercise training and home-
based walking programme on daily physical activity (PA) compared with standard medical
Participants Consecutive patients with stable COPD at Gold Stage II with a score of 2 or
1
Intervention Ten-week combined exercise training and home-based walking programme
Main outcomes At baseline and after 10 weeks, daily PA was evaluated by accelerometry
using three levels of intensity and expressed as metabolic equivalent of task. In addition, daily
activities (Physical Activity Scale for the Elderly), functional exercise capacity (6-minute
Walk Test), health-related quality of life (Chronic Respiratory Questionnaire) and exercise
Results Fifty-two patients {34 females; mean age 70.2 [standard deviation (SD) 9.5] years;
mean forced expiratory volume in 1 second 67% (SD 9.2) of predicted} were randomised.
PA, adjusted for baseline differences, increased significantly in the intervention group
compared with the control group, by 26.1 minutes/day [95% confidence interval (CI) 7.3 to
44.9]. The increase in functional capacity between groups was clinically relevant (34.0 m,
<A>Introduction
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease of the
causing deconditioning and physical inactivity [2,3]. The prevalence of COPD increases
steeply to more than 10% amongst those aged 40 years or over [4]. Direct costs account for
over 3% (48.4 billion Euros) of the total healthcare budget in the European Union [5]. COPD
2
is the third leading cause of death worldwide, and in 2015, it was ranked fifth in terms of
Of patients with COPD, those with moderate COPD comprise the largest group in Dutch
general practice. These patients are markedly inactive compared with their healthy age-
matched peers, and also when compared with patients with other diseases [7]. In patients with
strategy to minimise dyspnoea [3]. In the mild to moderate stages, the decrease in PA is more
pronounced in patients with mild symptoms of dyspnoea and those with lower levels of
diffusion capacity, exercise capacity and self-efficacy [3,8]. Additionally, the PA level is
such as muscle weakness, osteoporosis and cardiovascular disease, and is the strongest
enhance PA during exercise training [14]. Moderate COPD may be the ideal target for
intervention as patients are at the onset of becoming sedentary but only marginally limited in
physical and ventilatory terms [2,3,15]. Studies on enhancing PA by exercise training in the
mild-to-moderate stages have been scarce. A primary care programme of exercise training and
3
Furthermore, a meta-analysis of centre-based PR programmes in patients with (very) severe
An important feature in exercise adherence seems to be the use of normal daily life activities,
in which walking has been reviewed as the most successful component in behavioural
intervention in COPD [18]. Home-based programmes using normal life activities, including
walking, may have an additional and more sustainable effect on daily PA. However, to the
life activities have been evaluated in a randomised controlled trial of patients with moderate
COPD.
This study aimed to compare the effectiveness of an exercise training programme with
additional home-based walking exercises with standard medical care on PA in patients with
<A>Methods
<B>Study design
In this randomised controlled trial, eligible participants were allocated to the intervention
group or the control group. The intervention group participated in a 10-week supervised
exercise training programme combined with home-based walking exercises. The control
group received standard medical care (i.e. wait and see). There was no additional optimisation
<B>Participants
4
An active search of patients in primary general care practices and the local hospital was
undertaken. Patients were included in the study after referral for physiotherapy by a primary
care physician. Recruitment took place from June 2009 to May 2013 in two medium-sized
towns in the north of The Netherlands, throughout the year to avoid seasonal bias in the
measurements. Clinically stable patients with known COPD, diagnosed as GOLD Stage II
[50% ≤ forced expiratory volume in 1 second (FEV1) < 80%] according to the GOLD criteria
[1], were eligible if they also had a score of 2 or more on the Medical Research Council
severe cardiac or musculoskeletal diseases) were excluded from this study. All individuals
gave written informed consent, and ethical approval was granted by the Medical Ethics
<B>Randomisation
Allocation was randomised and concealed using opaque-sealed envelopes. All possible
sequences in permuted blocks of four with two intervention and two control tickets were
created and placed at random in sequentially numbered order by an individual not affiliated to
the study. At intake and under the supervision of the physiotherapist in the primary care
centre, participants were instructed to open the first envelope. Block randomisation was
necessary as no specific data on PA of patients with moderate COPD were available at the
outset of the trial. Using this procedure, interim analysis on established power was possible
after inclusion of approximately 25 and 50% of the study population (12 and 24 patients,
respectively).
<B>Interventions
5
The intervention programme involved a group-based circuit exercise training programme that
was executed in two primary physiotherapy care centres under the guidance of three
therapists. The intervention took place over 10 consecutive weeks, in which patients
performed exercises two times per week during 1-hour sessions. The centre-based programme
and extremity resistance exercises (further details on onset intensity, frequency duration and
progression of the workload are described in Appendix A, see online supplementary material).
During and between the exercise sessions, patients were instructed weekly about exercise
compliance and the importance of staying active in daily life. These education sessions took
place for 5 minutes each week, and were based on five important elements of educational
A, see online supplementary material). The intervention also included an unsupervised home
walking programme, with patients instructed to walk for at least 30 minutes for 1 day per
week on a fixed day of the week (day of patient’s choice) over the 10 weeks. Emphasis was
placed on continuity rather than on increasing training intensity and goal setting. Compliance
was checked verbally during training each week. Patients in the control group received
standard medical care from their general physician, which consisted of standard monitoring
<B>Measurements
PA, the primary outcome of this trial, was recorded in minutes per day using a uniaxial
accelerometer personal activity monitor (PAM), quantifying the amount of motion in the
vertical plane with an energy expenditure of 0.8 METs or more. The test–retest reliability of
the PAM is good, and it correlates highly with the Actigraph accelerometer for treadmill
walking and stair walking [20]. In addition, the PAM is capable of measuring three different
6
levels of PA intensity, expressed as metabolic equivalent of task (MET), as recommended by
the ATS/ERS [14]. Energy expenditure during PA is graded as low (1.8 to 3 METs), moderate
(more than 3 METs) or vigorous (more than 7 METs) [21]. The lightweight PAM was worn at
As a secondary outcome measure, daily activities were measured using the Physical Activity
Scale for Elderly (PASE). Concurrent validity compared with accelerometry was variable
(r=0.42 and 0.17) and test–retest reliability (intraclass correlation coefficient) was 0.65 [22].
Functional exercise capacity (FEC) was measured with the 6-minute Walk Test and expressed
as the 6-minute walk distance (6MWD). Assessment was performed by the treating
quality of life (HRQoL) was measured by the self-administrated version of the Chronic
Respiratory Questionnaire with a MCID per domain of 0.5 [24]. Exercise self-efficacy was
All measurements were performed after allocation at baseline 1 week before and 1 week after
the 10-week intervention period for both groups. The intervention programme started after
completion of all measurements. Due to the setting of the research, the outcome assessor was
not blinded. Instructions on how to wear the PAM and other information about the PAM was
shared with the patients. The device did not provide feedback. Compliance with wearing the
<B>Statistical analysis
7
Descriptive data were described as mean [standard deviation (SD)] or median (min to max).
Statistical differences were calculated using independent t-tests or Mann–Whitney U-tests for
between-group differences, and paired t-tests or Wilcoxon matched pairs signed rank sum t-
principle using all available data. Correlations between changes in PA and secondary
outcomes were expressed using Pearson’s correlation coefficients. To adjust for baseline
inequality in potentially clinically relevant prognostic factors between the two groups,
multivariate linear regression was conducted including all unbalanced predictors as co-
variables [3,9].
Sample size was calculated using an alpha of 0.05 and power of 80%, which gave a sample
size of 52 patients (26 per treatment arm) to allow detection of a mean improvement in
walking time of 21 min (or 50% improvement) in the intervention group [26]. Statistical
analysis was performed using SPSS Statistics Version 24.0 (IBM Corp., Armonk, NY, USA).
<A>Results
Sixty-four patients with COPD were referred. Five patients were GOLD Stage I and were
excluded, and three eligible patients decided not to enter the study. At intake, four patients did
not have an MRC score of 2 or more, and were therefore excluded (Fig. A, see online
Over the 10-week intervention period, seven patients were lost to follow-up. In the
intervention group, two patients dropped out because of a traumatic accident and orthopaedic
complaints during leisure time, and one patient dropped out due to a non-COPD-related
8
internal organ disorder. Four patients, two in each group, had a severe exacerbation and
The intervention group (n=26) and the control group (n=26) consisted of 18 (69%) and 16
(62%) females, with mean age of 69.4 (SD 9.7) and 71 (SD 9.4) years, mean FEV1 of 68%
(SD 7.7) and 65 (SD 10.3) of predicted, and mean body mass index 28.2 of (SD 5.5) kg/m2
and 27.2 (SD 4.3), respectively (Table A, see online supplementary material).
The mean time frame of wearing the activity monitor was 6.8 (SD 0.7) days; this was similar
in both groups, with no periods of unrecorded activity of less than 1 minute (SD 0.1) reported.
The mean number of training sessions was 18.2 (SD 1.1) and 8.6 (SD 0.4) for exercise
<B>Primary outcome
In the intervention group, PA increased from 66.8 to 90.8 minutes/day (mean difference 24.0,
95% CI 9.2 to 38.9), while the control group showed a decrease in PA (mean difference -1.2,
95% CI -12.7 to 10.3), resulting in a significant mean difference between the groups of 25.2
minutes/day (95% CI 7.3 to 43.1). After adjusting for the unbalanced, potentially clinically
relevant prognostic baseline co-variables (PA, 6MWD and exercise self-efficacy), a mean
favour of the intervention group (Table 1). This difference was divided into 19.2 minutes/day
moderate-intensity PA (P=0.12).
The 6MWD increased significantly in the intervention group (P<0.001). After controlling for
baseline differences in PA, 6MWD and exercise self-efficacy, a clinically relevant increase in
6MWD was observed, with a between-group difference of 33.96 m (Table B, see online
supplementary material). The PASE score showed no significant difference between the
groups (P=0.25). Leisure activities, dyspnoea and total HRQoL showed a significant change
The increase in PA in the intervention group correlated significantly with the change in the
PASE score (r=0.408, P=0.037). PA was weakly and not significantly correlated with changes
in FEC, leisure time, dyspnoea, exercise self-efficacy and HRQoL (Table C, see online
supplementary material).
<A>Discussion
exercise training programme combined with home-based walking, compared with standard
Only a few randomised clinical trials on enhancing PA by exercise training have been
performed, and most have been combined with PR. This study of patients with moderate
COPD showed that exercise training had a significant effect on FEC [14,15]. However, a
comparable primary care programme of exercise training and promoting PA in patients with
studies with patients with (very) severe COPD showed an overall small pooled effect size of
0.12, which is equivalent to a slight increase in PA of 4.5 minutes/day [17]. The authors
10
concluded that the increased FEC, shown by the 6MWD, was only weakly correlated with PA
and this is not automatically transmitted into increased PA. Therefore, as well as centre-based
training, it also seems to be necessary to integrate exercise into daily life activities to enhance
pedometer feedback. These multimodal approaches are generally effective in enhancing PA,
but they are also more comprehensive and expensive, need individualisation, and are more
PA increased significantly in this study, but the authors were not able to determine which
domain of activities was associated with the increase as the change in the PASE score was not
significant. This could be explained by the fact that questionnaires do not always yield a
In the intervention group, the 6MWD increased by 52 m; this was significant and clinically
relevant, and is comparable with the regular mean increase of 44 m induced by PR. Therefore,
FEC seems to have improved compared with the standard exercise programme [33]. HRQoL
6MWD and HRQoL were not significant. This may be due to the power calculation not being
In this trial, the increased FEC was only marginally correlated with the increase in PA. This is
in accordance with recent research, and was expected as the target population is, in general,
only marginally limited in physical and ventilatory terms [16,34]. Whether a behavioural
change contributed to the increase in PA was not shown by higher values in exercise self-
11
efficacy. However, the unknown responsiveness of the Ex-SRES questionnaire is unknown.
This questionnaire was, however, the best option available at the outset of this study.
Despite the fact that triaxial devices tend to have better validity than uniaxial devices [35],
accelerometry is currently accepted as the most accurate method for the assessment of daily
PA in patients with COPD [32]. The PAM is regarded as an unobtrusive instrument with high
The extent to which the improved PA should affect health conditions and disease deterioration
remains unclear as no MCID has been stated. The total amount of moderate-intensity PA in
the intervention group increased to a mean of 17.2 minutes/day, which is still insufficient
<B>Study limitations
patients with mild-to-moderate COPD, and an MRC score of 2 or more, as these patients have
less advanced symptoms and complaints [15]. The results of the programme are therefore not
interchangeable and not automatically applicable to patients with more severe COPD, or
Second, the precision of the presented effect on PA may be limited as dropouts were not taken
into account in the sample size calculation. However, the improvement in PA in the
intervention group was clearly higher, and the power may therefore be regarded as sufficient.
Third, there was an inevitable lack of blinding of the physiotherapists and the outcome
assessor. The consequent risk of bias can, however, be expected to be marginal as the primary
12
Finally, a weakness of this study may have been the inability to perform a valid assessment of
adherence to the home-based walking programme. The authors attempted to minimise this
risk of bias by checking compliance verbally. However, participants could have given a
socially desirable response, which may have overestimated the effect of the programme on
PA.
<A>Conclusions
training programme for increasing PA in patients with moderate COPD. Further research
should investigate optimal frequency and intensity of the combined interventions, and also
Ethical approval: The Medical Ethics Assessment Board of the Academic Medical Centre,
Funding: Eight activity monitors were provided without charge by PAM. PAM had no
Acknowledgements
The authors would like to thank all participating patients, general practices and colleagues for
their efforts.
13
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Fig. A. CONSORT flow diagram. MRC, Medical Research Council Dyspnoea Scale.
Excluded (n=12)
Did not meet inclusion criteria (n=9)
- n=5: GOLD Stage I
- n=4: MRC score <2
Declined to participate (n=3)
Randomised (n=52)
19
Table 1
Physical activity at baseline and after intervention for intervention (n=21) and control (n=24) groups.
Measurements T0 T10 Within-group Within- Between-group Between-
mean (SD) mean (SD) effect group effect group
Mean (95% CI) effect Mean (95% CI)a effect P
P
Total PA 26.1 (7.3 to 44.9) 0.037b
(minutes/day)
- Intervention group 66.8 (30.4) 90.8 (38.6) 24 (9.2 to 38.9) 0.003b
- Control group 66.8 (29.3) 65.6 (38.8) -1.2 (-12.7 to 0.84
10.3)
Low-intensity PA (minutes/day) 19.2 (5.2 to 33.3) 0.035b
b
- Intervention group 55.4 (21.9) 73.6 (27.8) 18.2 (6.4 to 0.004
30.0)
- Control group 55.9 (22.4) 55.5 (27.2) -0.4 (-8.9 to 8.2) 0.93
Moderate-intensity PA (minutes/day) 6.6 (-1.0 to 14.8) 0.12
- Intervention group 11.9 (11.0) 17.2 (15.8) 5.4 (-0.4 to 11.1) 0.06
- Control group 10.9 (10.0) 10.1 (14.2) -0.8 (-5.0 to 3.3) 0.69
PA, physical activity; SD, standard deviation; CI, confidence interval.
P-values within-group effect from paired samples t-test and between-group effect differences from Student’s t-
test.
a
Adjusted for baseline differences in PA, 6-minute walk distance and exercise self-efficacy.
b
Significance level 0.05.
20
Table A
BMI, body mass index; CRQ, Chronic Respiratory Questionnaire; FEV1, forced expiratory volume in 1 second;
FEV1/FVC= Tiffeneau index; PA, physical activity; PASE, Physical Activity Scale for Elderly; 6MWD, 6-
minute walk distance.
Note: values are presented as % or mean (standard deviation), except PASE leisure, household, work and total:
median (min to max). Between-group differences from Student’s t-test except PASE household and work:
Mann–Whitney U-test.
21
Table B
Secondary outcome measurements after randomisation and after intervention period for intervention (n=21) and control (n=24) groups
Measurements Measure T0 Measure T10 Within-group Within - Between-group Between-
mean (SD) mean (SD) effect group effect group
Mean (95% CI) effect Mean (95% CI)a effect
P P
6MWD 34.0 (2.3 to 65.6) 0.27
b
- Intervention group 354.3 (77.9) 406.6 (90.9) 52.3 (34.2 to <0.001
70.4)
- Control group 350.4 (85.9) 363.6 (83.2) 13.2 (-12.9 to 0.31
39.3)
PASE leisure 2.9 (0.7 to 5.2) 0.020b
b
- Intervention group 13.6 (4.4) 15.3(4.2) 1.7 (0.1 to 3.4) 0.042
- Control group 11.8 (2.6) 12.7(3) 0 (-3 to 2) 0.15
PASE housework -0.1 (-0.8 to 0.7) 0.79
- Intervention group 8 (6 to 12)c 9 (6 to 11)c 0 (-1 to 3) 0.77
- Control group 8 (6 to 11)c 9 (7 to 11)c 0 (-3 to 2) 0.28
PASE work 0.1 (-0.8 to 0.9) 0.91
- Intervention group 1 (1 to 5)c 1 (1 to 5)c 0 (0 to 0) 0.32
- Control group 1 (1 to 6)c 1 (1 to 6)c 0 (-3 to 0) 1.00
PASE total 2.9 (0.5 to 5.4) 0.10
- Intervention group 23.9 (5.2) 25.7 (5.2) 1.8 (-0.2 to 3.8) 0.07
- Control group 22 (3.1) 23.1 (3.6) 1.13 (-0.9 to 3.2) 0.26
PASE score 16.2 (-13.2 to 45.5) 0.25
- Intervention group 120.2 (77.2) 126.1 (61.2) 5.9 (-21.0 to 32.9) 0.65
- Control group 104.1 (54.9) 106.8 (49.5) 2.7 (-21.1 to 26.4) 0.82
Exercise self-efficacy 18.9 (-129.8 to 0.54
167.7)
- Intervention group 915.2 (278) 943.8 (380.5) 28.6 (-74.9 to 0.57
132.1)
- Control group 1024.1 (300.4) 1004.5 (252.6) -130 (-430 to -80) 0.72
22
CRQ dyspnoea 1.1 (-3.2 to 5.3) 0.70
b
- Intervention group 18.1(5.6) 22.3 (6.64) 4.1 (1.85 to 6.43) 0.001
- Control group 19.8(6.1) 21.5 (7.48) 1.7 (-1.02 to 4.44) 0.21
CRQ emotion 1.4 (-2.8 to 5.7) 0.48
- Intervention group 31.7 (6.9) 34.4 (6.7) 2.7 (-0.3 to 5.8) 0.08
- Control group 32 (7.7) 33 (6.8) 1 (-1.6 to 3.5) 0.45
CRQ fatigue 1.2 (-1.6 to 3.9) 0.46
- Intervention group 16.3 (4.1) 17.9 (4.8) 1.5 (-1.2 to 4.2) 0.25
- Control group 16.2 (4.6) 16.8 (5) 0.6 (-1.7 to 2.5) 0.38
CRQ mastery 0.9 (-1.6 to 3.2) 0.71
- Intervention group 19.9 (4.8) 20.8(3.6) 1 (-0.8 to 2.8) 0.28
- Control group 20 (5.5) 20.3(4.9) 0.4 (-1.7 to 2.5) 0.71
CRQ total 4.4 (-5.4 to 14.2) 0.47
- Intervention group 86 (13.4) 95.3 (16.3) 9.3 (2.55 to 16.1) 0.009b
- Control group 88 (18.5) 91.6 (18) 3.6 (-2.7 to 10) 0.25
CRQ, Chronic Respiratory Questionnaire; PA, physical activity; PASE, Physical Activity Scale for Elderly; 6MWD, 6-minute walk distance.
P-values within-group effect from paired samples t-test except PASE household and work: Wilcoxon matched pairs signed rank sum t-test. Between-group effect from
Student’s t-test and Mann–Whitney U-test.
a
Adjusted for baseline differences in PA, 6MWD and exercise self-efficacy.
b
Significance level 0.05.
c
Median (min to max).
23
Table C
Pearson correlation coefficient (r) between changes in the intervention group (n=21) in physical
activity and other outcomes greater than 0
Correlation PASE score 6MWT PASE leisure CRQ Self-efficacy CRQ total
dyspnoea
PA 0.41a 0.35 0.14b 0.10 0.07 0.02
CRQ, Chronic Respiratory Questionnaire; PA, physical activity (objective); PASE, Physical Activity Scale for
Elderly (subjective); 6MWT, 6-minute Walk Test.
a
Significance level 0.05.
b
Spearman Rho (rs).
24