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. 2022 Aug 22;2022(8):CD013485. doi: 10.1002/14651858.CD013485.pub2

Orooj 2020.

Study characteristics
Methods Study design: RCT
Total duration of study: 6 weeks
Details of any run‐in period: None stated
Number of study centres and location: Single site. India
Study setting: Hospital
Withdrawals: None reported
Date of study: Not stated
Participants Number recruited: Randomised to intervention group: 14. Randomised to control group: 14
Number completed: Completed intervention group: 14. Completed control group: 14
Mean (SD) age: Intervention group 66 (8.4) years. Control group 67 (6.29) years
Age range: Not stated
Gender (M/F): Not stated
Mean (SD) BMI: Intervention group 24 (4.3) kg/m2. Control group 23 (5.1) kg/m2
Severity of condition: All participants had a diagnosis of ACO. Severity not stated.
Diagnostic criteria: Participants were diagnosed with ACO according to syndromic and spirometric features from the GINA/GOLD joint documents.
Baseline lung function: Mean (SD) % predicted FEV1: Intervention group 65.1 (26.7)%. Control group 62.8 (15.6)%
Smoking history: Mean (SD) smoking pack year: Intervention group 11 (3.25). Control group 11.0 (2.9)
Asthma treatment: Not stated
Inclusion criteria: Diagnosis of ACO
Exclusion criteria: History of myocardial infarction, angina, congestive heart failure. Orthopaedic or cognitive impairment that would interfere with participation in rehabilitation. History of thoracic surgical intervention
Interventions Intervention: 6‐week hospital‐based PRP. Exercise component supervised by physiotherapist. Endurance training on treadmill at 60% to 80% of VO2 peak 5 times per week. Resistance training of upper and lower limbs at 50% to 70% 1RM 3 times per week. Structured self‐management education programme including relaxation techniques, smoking cessation, and nutrition
Comparison: Usual care
Concomitant medications: Not stated
Excluded medications: Not stated
Outcomes Primary outcomes: Exercise capacity (6MWD). Quality of life (SGRQ). Lung function (spirometry). Bode Index
Secondary outcomes: Not stated
Time points reported: Baseline and end of intervention (6 weeks)
Data reported as endpoint rather than as change from baseline. SMD (95% CI) between groups at end of intervention also reported.
Notes Funding: No funding was received for the study.
Notable conflicts of interest: No competing interests declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “patients were randomly allocated using computer‐generated block randomization to either the PR group or to the control group”
Allocation concealment (selection bias) Unclear risk No details given
Blinding of participants and personnel (performance bias)
Subjectively reported outcomes High risk Rehabilitation intervention. No mention of blinding of participants or study personnel.
Blinding of participants and personnel (performance bias)
Not subjectively reported outcomes High risk Rehabilitation intervention. No mention of blinding of participants or study personnel.
Blinding of outcome assessment (detection bias)
Subjectively reported outcomes Unclear risk No mention of blinding assessors.
Blinding of outcome assessment (detection bias)
Not subjectively assessed outcomes Unclear risk No mention of blinding assessors.
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts. “All 28 participants enrolled in the investigation completed the study”.
Selective reporting (reporting bias) Unclear risk No published protocol.
Other bias Unclear risk No data on gender of participants provided.