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 |
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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 |
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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 |
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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. |
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Notes |
Funding: No funding was received for the study. Notable conflicts of interest: No competing interests declared. |
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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. |