[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: Patients with moderate COPD as defined by the GOLD [17] criteria (FEV1/FVC, % 70%;FEV1 70% and >50% predicted), a 10 pack-year smoking history and self-reported functional impairment.
Excluded criteria: Exclusion criteria included current smokers, pulmonary diseases other than COPD, use of supplemental oxygen, musculo-skeletal disease that impaired exercise performance and unstable coronary artery disease or congestive heart failure.
Pretreatment: There is no difference between subjects at baseline.
Intervention Characteristics
Intervention 1
Intervention 2
Control
Quality of life, SE
Quality of life, CI
Quality of life, SD
Mortality, n
Bike test/cardio-pulmonary test, SE
Walk test (6-min or SWT), CI
Walk test (6-min or SWT), SD
Walk test (6-min or SWT), SE
Dropout, n
Quality of life, SD (longest follow-up)
Mortality, SD (longest follow-up)
Bike test/cardio-pulmonary test, SD (longest follow-up)
Walk test (6min or SWT), SD (longest follow-up)
Sponsorship source: This study was supported by a research grant awarded by Breathe LA(formerly the American Lung Association of Los Angeles County). Thecommunity-based exercise training sessions were provided at the EquinoxFitness Club, Century City, CA; at Phase VI Scientific Health and PerformanceCenter, Santa Monica, CA; and at Mitchell Fitness Systems, Torrance, CA
Country: USA
Setting:
Comments: ClinicalTrials.gov Identifier NCT01985529.
Authors name: Shefalee Amin
Institution: Exercise Physiology Research Laboratory, Departments of Physiology
Email: CCooper@mednet.ucla.edu
Address: Exercise Physiology Research Laboratory, Departments of Physiology andMedicine, David Geffen School of Medicine at University of California, LosAngeles, 37-131 Center for Health Sciences, 10833 Le Conte Avenue, LosAngeles, CA 90095-1690, USA
Notes: Outcomes
Quality of life: SGRQ, end of treatment SEMBike test: Endurance-time for constant work rate test (s), end treatment, mean(SEM)Dropout: no. of patients end of treatment
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Overall
Included criteria: Clinically stable patients withknown COPD, diagnosed as GOLD Stage II [50%≤forcedexpiratory volume in 1 second (FEV1) 80%] according tothe GOLD criteria[1], were eligible if they also had ascore of two or more on the Medical Research CouncilDyspnoea Scale, including dyspnoea on this level as a impor-tant prognostic predictor of decreased PA
Excluded criteria: Patients with exercise-restricting, non-COPD-related complaints (e.g.severe cardiac or musculoskeletal diseases) were excluded from this study
Intervention Characteristics
Intervention 1
Intervention 2
Control
Quality of life, SE
Quality of life, CI
Quality of life, SD
Mortality, n
Bike test/cardio-pulmonary test, SE
Walk test (6-min or SWT), CI
Walk test (6-min or SWT), SD
Walk test (6-min or SWT), SE
Dropout, n
Quality of life, SD (longest follow-up)
Mortality, SD (longest follow-up)
Bike test/cardio-pulmonary test, SD (longest follow-up)
Walk test (6min or SWT), SD (longest follow-up)
Sponsorship source: Funding: Eight activity monitors were provided withoutcharge by PAM. PAM had no involvement in the study.
Country: The Netherlands
Setting:
Comments: Clinical trial registration number NL24766.018.08.
Authors name: P. de Roos
Institution: Physiotherapy Centre De Oppers, De Oppers 3, 9203 GD Drachten, The Netherlands
Email: pieterderoos@chello.nl, p.deroos@hotmail.com
Address: Physiotherapy Centre De Oppers, De Oppers 3, 9203 GD Drachten, The Netherlands
RCT
Patients with moderate COPD, FEV1 of predicted=64-67%, MRC=1.91-2.0 Participants comprised 61 of 133 referred subjects with
moderate COPD. Of the 61 participants, 35 were randomized to
receive rehabilitation and 26 subjects to receive standard COPD
care from their GP. After randomization 19 subjects dropped
out
7-week pulmonary rehabilitation programme and an 18-month
follow-up survey or usual care (no rehab)
(1) A preliminary motivational personal interview, V1.
(2) An intensive 7-week physical training and educational
phase led by a multidisciplinary team starting within 1
month of V1.
(3) A final interview following completion of the intensive
program, V2 (6 months after V1 for subjects in the control
group).
(4) Follow-up, V3 at 12months afterV1 andV4 at 18months
after V1.
HRQoL(SGRQ), walking test(6MWT), Lung function
RCT
Patients wih mild to moderate COPD FEV1 of predicted= 74-75%. GOLD stage 1-2. A total of 132 patients with confirmed diagnosis of COPD but no serious comorbidities
were randomly allocated to the HQG group (n=51), PR group (n=32), or medical treatment
group (n=35).
The HQG group received 1 week of HQG training under the supervision of
professional coaches, and were then encouraged to participate in a peer-led weekly practice
group thrice a week, lasting 1 hour each time, for 6 months. The conventional PR group
received the same amount of professional coaching on breathing and aerobic exercises, and
peer-led walking or ball game groups. The medical treatment group only received health
education on self-exercise.
HRQoL(Zhongshen questionnaire), walking test(6MWT), Lung function, immune cell factors, COPD related admissions
RCT
97 patients with moderate COPD. MRC=2 or less. FEV1 of predicted= 60%. 3-month Pulmonary Rehabilitation (PR) program with a
further 9 months of maintenance (RHBM group n=32) compared with both PR for 3 months without further maintenance
(RHB group N=33) and usual care N=32. Follow-up at 4 (after PR) and 12 months
a) Education program. During weeks 1, 6, and 12,
patients received a 45-minute education session on
the anatomy and physiology of the respiratory
system, the correct use of inhalers and brief
counseling on smoking cessation.
b) Respiratory Physiotherapy. Each session included a
series of exercises, lasting a total of 15 minutes and
including self-conscious breathing control,
diaphragmatic breathing control, and exercises for
the chest wall and abdominal muscle walls.
c) Low intensity peripheral muscle training. Each
session included abdominal and upper and lower
limb exercises, shoulder and full arm circling,
weight-lifting and other exercises. This training has
been described previously [21] and used in other
clinical trials [22,23]. Each exercise was repeated 8–
10 times over 45 minutes.
Control group
These patients did not participate in either of the intervention
programs; rather, they remained under the routine
care of their general practitioner and nurse throughout
HRQoL(CRQ), walking test(6MWT), COPD related admissions
RCT
199 patients with COPD, baseline FEV1 of predicted 58-60%, MRC score 1.5-1.7. Randomised into INTERCOM rehab=102 or usual care 97
The intervention: 4-month standardised
supervised rehabilitation phase and a 20-month active
maintenance phase. The programme was designed to improve
and subsequently maintain exercise capacity, to promote selfmanagement
skills and improve knowledge of COPD.
Nutritional intervention and smoking cessation support were
provided when indicated.During the first 4 months the patients visited the physiotherapists
twice a week (30 min per visit) for intensive
exercise training consisting of endurance training (cycling and
walking) and four specific exercises for upper and lower
extremities to improve both strength and endurance without
the use of special equipment. Patients were instructed to
perform the same exercises twice a day during 30 min in their
home environment in addition to walking and cycling outside.
Furthermore, all patients participated in an individualised
education programme that was structured using a patient
education book. All smokers were assigned to the respiratory
nurse for standardised smoking cessetion.12
Nutritionally depleted patients received scheduled counselling
(four visits) by a dietician and nutritional supplements
(Respifor, Nutricia, The Netherlands).
Primary outcomes were change from baseline in disease-specific
quality of life as assessed by the St George’s Respiratory
Questionnaire (SGRQ) total score and the total number of
exacerbations (moderate plus severe)
Secondary outcomes were change from baseline in subscores
of the SGRQ (symptom, activity and impact scores), dyspnoea
(modified MRC dyspnoea scale),16 exercise performance
(Wmax), cycle endurance test (CET) at 50% Wmax for maximal
10 min and thereafter at 70% Wmax until exhaustion,13 6-
minute walking test (6MWD), muscle strength (handgrip force
(HGF), isometric quadriceps peak torque (QPT), maximal
inspiratory mouth pressure (Pimax)),17 body composition (fatfree
mass (FFM))18 and lung function.
SGRQ, C-P exercise test, 6MWT, muscle strength
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Nothing mentioned
not stated
block randomisation
computer randomisation
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 enve- lope. Block randomisation was necessary as no specific data on PA of patients with moderate COPD were available at the outset of the trial.
computer randomisation
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Nothing mentioned
sealed envelopes
not stated
computer randomisation
Allocation was randomised and concealed using opaque- sealed envelopes.
computer randomisation
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Nothing mentioned
not blinded
not blinded
not blinded
Nothing mentioned
not blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Nothing mentioned
not blinded
blinded
blinded
Nothing mentioned
blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
The n of each group is not clearly stated.
high drop out rate
1 drop out
More than 50% drop out rate
No other apparent bias
difference between groups in drop outs
Reporting bias due to selective outcome reporting
Matches protocol
not detected
not detected
not detected
Matches the study protocol
not detected
Bias due to problems not covered elsewhere in the table
No other apparent bias
not detected
none detected
non detected
No other apparent bias
none detected