Cambach 1997.
Study characteristics | ||
Methods |
Study design: Randomised cross‐over trial Total duration of study: 6 months Details of any run‐in period: None stated Number of study centres and location: Multicentre study. The Netherlands Study setting: Community‐based local physiotherapy practices Withdrawals: Overall 99 participants were randomised (including asthma and COPD). 46 randomised to intervention group (9 participants withdrew). 43 randomised to control group (14 participants withdrew). Not clear how many of the participants who withdrew had asthma diagnosis Date of study: June 1992 to July 1994 |
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Participants |
Number recruited: 89 participants with a diagnosis of asthma or COPD randomly assigned to intervention (n = 46) or control (n = 43) group. The number of participants with an asthma diagnosis who were randomly assigned to each group is not stated. Number completed: Intervention group (22). Control group (21) (asthma participants only) Mean (SD) age: Intervention group 40 (10) years. Control group 53 (15) years (asthma participants only) Age range: Not stated for asthma participants only Gender (M/F): Intervention group 4/18. Control group 7/14 (asthma participants only) Mean (SD) BMI: Not stated for asthma participants only Severity of condition: Not stated Diagnostic criteria: Complaints of dyspnoea occurring periodically with varying severity, at the present time or in the past, as well as an increase in FEV1 of at least 15% postbronchodilator, or a histamine provocation test producing a 20% fall in FEV1 (PC20) of < 8 mg/mL Baseline lung function: Mean (SD) % predicted FEV1 for asthma participants only: Intervention group 89 (17)%. Control group 84 (20)% Smoking history: Not stated for asthma participants only Asthma treatment: Not stated Inclusion criteria: Evidence of dyspnoea and decreased exercise tolerance due to obstructive lung disease. Age 18 to 75 years. Ability to travel independently to physiotherapy practice. Medication prescribed by a pulmonary physician. No manifest cardiac complaints or locomotor disabilities. Absence of hypercapnia or hypoxia, or both, during rest or maximal exercise testing. Motivation to self‐care. Informed consent Exclusion criteria: Hypoxaemia. Not meeting diagnostic criterion of “obstructive lung disease” |
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Interventions |
Intervention: 3‐month community‐based PRP consisting of upper and lower limb exercise training x 3 days per week x 90 minutes and education delivered by physiotherapists and district nurses Comparison: Medication alone Concomitant medications: Not stated Excluded medications: Not stated |
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Outcomes |
Primary outcomes: Exercise capacity (endurance cycle ergometer test, submaximal cycle ergometer test, 6MWD). Quality of life (CRQ) Secondary outcomes: None stated Time points reported: Baseline, 3 months, 6 months. 6‐month data not included in review, as cross‐over had occurred. Data reported as change from baseline. |
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Notes |
Funding: National Health Insurance Council subsidised and supported the study. Notable conflicts of interest: None stated Other: Data for asthma participants only at baseline and 3 months only before cross‐over occurred are included in this review. The number of participants analysed in each arm varied slightly according to outcome measure. Data from participants who did not return for 1 or more of the assessments or participants who were not measured within 3 weeks from baseline or programme completion were excluded from data analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not clear how the sequence was generated. “Within each physiotherapy practice, four out of eight patients were randomly allocated to group RC, and four patients to group CR (block randomization procedure; four closed envelopes for condition RC and four closed envelopes for condition CR).” |
Allocation concealment (selection bias) | Unclear risk | Not clear how they decided which envelope to open, or whether envelopes were labelled. “Within each physiotherapy practice, four out of eight patients were randomly allocated to group RC, and four patients to group CR (block randomization procedure; four closed envelopes for condition RC and four closed envelopes for condition CR).” |
Blinding of participants and personnel (performance bias) Subjectively reported outcomes | High risk | Rehab programme‐ not able to blind participants or personnel delivering it. |
Blinding of participants and personnel (performance bias) Not subjectively reported outcomes | High risk | Rehab programme ‐ not able to blind participants or personnel delivering it. |
Blinding of outcome assessment (detection bias) Subjectively reported outcomes | Unclear risk | No mention of blinding of outcome assessors. |
Blinding of outcome assessment (detection bias) Not subjectively assessed outcomes | Unclear risk | No mention of blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 99 patients recruited but data only reported for 66. No ITT data reported. “Data obtained from patients who did not return for one or more of the assessments (i.e. baseline (T0), after 3 months (T3) and/or after 6 months (T6)), or patients who were not measured within 3 weeks (from T0, T3 and T6) were excluded from data analysis.” |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Low risk | No other suggestions of bias evident. |