Mutwalli 2012.
Methods |
Study design: Single centre RCT Country: Kingdom of Saudi Arabia Dates patients recruited: 8 June 2008 to 3 January 2010 Maximum follow up: 6 months |
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Participants |
Inclusion criteria: Patients admitted for coronary artery bypass graft (CABG) surgery. Exclusion criteria: History of ejection fraction less than 30%, poor mobility leading to difficulty in walking, chronic atrial fibrillation, repeat CABG or implantable pacemaker were excluded from the study. N Randomised: total: 49; intervention: 28; comparator:21 Diagnosis (% of pts): post‐CABG: 100% Age (years): intervention: 56.75 (range 53.6 ‐ 59.8); comparator: 57.22 (range 54.4 ‐ 60.2) Percentage male: intervention: 100%; comparator: 100% Ethnicity: NR |
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Interventions |
Intervention: Whilst in the cardiac ward, the participants walked daily for 30 minutes. Additionally, before discharge, the participants climbed one flight of stairs and were then asked to walk unaided at a comfortable pace 30 minutes per day until they completed the 6‐month home‐based CR programme. Components: exercise plus education. Setting: at home, unsupervised with telephone support. Aerobic exercise: Modality: walking. Length of session: 30 minutes. Frequency: daily. Intensity: NR Resistance training included? No. Total duration: 6 months. Co‐interventions: Patients received pre‐CABG, immediately post‐CABG, and home‐based CR program, including education, food management education and a one‐hour group workshop which included advice on modifiable and non‐modifiable risk factors, change of lifestyle, active life, stress, and then discussed participant’s problems and feelings during the past 2‐months. This group workshop was repeated 4‐months and 6‐months after hospital discharge. Comparator: The control group received standard hospital care, including regular advice from doctors and followed usual hospital instructions. This did not include a rehabilitation programme or telephone calls by the study authors. Co‐interventions: None described. |
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Outcomes | Mortality, MI, hospitalisation and HRQL. | |
Source of funding | "Work was not supported or funded by any drug company.” | |
Conflicts of interest | “Authors have no conflict of interests.” | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients who consented to participate in the study, were randomly assigned....” |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7/50 pts (14%) lost to follow up: one from control group died (1/22, 5%) and 6 from the intervention group (6/28, 21%) could not complete the study requirements. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods are reported at all time points. |
Groups balanced at baseline | Low risk | “there were no significant differences between the 2 groups in age and risk factors at baseline (p > 0.05).” |
Intention‐to‐treat analysis conducted | High risk | Intention‐to‐treat analysis is not stated, and Table 4 suggests this was not conducted. There are no details of how missing data was handled. |
Groups received same treatment (apart from the intervention) | Low risk | "This (control) group followed the usual hospital care and did not receive rehabilitation programme or telephone calls by the authors". |