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. 2021 Aug 17;2021(8):CD013569. doi: 10.1002/14651858.CD013569.pub2

Ries 2003.

Study characteristics
Methods RCT, parallel group. Setting: USA. Study duration: 12 months
Participants 172 participants
Intervention: n = 87, Control: n = 85
Male: n = 89, Female: n = 75
Age, mean and SD: All: 67.1 ± 8.2
FEV1% predicted, mean and SD: All: 45
Inclusion criteria: Participants with lung diseases who completed an 8‐week, 12‐session comprehensive
pulmonary rehabilitation programme. Selection criteria for the pulmonary rehabilitation programme included: clinical diagnosis of chronic lung disease (obstructive) confirmed by history, physical examination, pulmonary function tests, and chest roentgenograms; chronic symptoms and perceived disability from disease; stable on an acceptable medical regimen under the care of a primary care physician; no other significant medical or psychiatric conditions that would interfere with full participation in the program; and commitment to abstain from smoking.
Exclusion criteria: not reported.
Interventions Intervention group:
Components: walking and arm strength training
Based on the results of initial exercise testing and used methods easily adapted to the home setting. Supervised walking exercise was begun on a treadmill and subsequently translated into an appropriate walking pace for home training. The training programme emphasized increasing endurance up to 20 to 30 minutes of continuous walking with increase in level as tolerated by symptom‐limits. In addition, participants performed an upper extremity training programme of arm lifts developed for pulmonary patients. Diaries were reviewed regularly during scheduled programme sessions. During supervised rehabilitation sessions, participants were also able to build upper extremity strength and endurance through the use of isokinetic arm cycle ergometers.
Supervision: weekly telephone calls and monthly supervised reinforcement sessions.
Control group:
A written daily home programme was provided for each participant and sent to their physician detailing individual recommendations for exercise training and other treatments developed within the rehabilitation programme.
Supervision: subjects were invited to regular monthly alumni group meetings.
Outcomes Exercise capacity: VO2 max with an incremental symptom‐limited treadmill test and 6MWD, HRQoL: SF‐36 (domains), CRQ (global score), Quality of well‐being scale‐QWB, hospitalisation and mortality.
Notes Supported by National Institutes of Health grant R01 HD/HL 30912.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was achieved using a random number generator.
Allocation concealment (selection bias) Low risk Allocation was achieved using the Moses‐Oakford assignment algorithm 1:1, sealed in sequentially numbered identical opaque envelopes.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blind patients and personnel.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Reported that "assessments were performed without identification".
Incomplete outcome data (attrition bias)
All outcomes Low risk Similar rates of attrition in each treatment arm.
Selective reporting (reporting bias) Unclear risk No protocol or trial registry information found, unclear if outcomes were reported as planned.
Other bias Low risk No other sources of bias were identified