| Methods | Parallel group RCT | |
| Participants |
N Randomised: 100 (Tai Chi (exercise) 50; education (control) 50) Diagnosis (% of participants): Aetiology: ischaemic 54%; non‐ischaemic 46% NYHA: Class I 20%; Class II 63%; Class III 17% LVEF: mean 29% (SD 8%) Case mix: 100% as above Age (yr): exercise 68.1 (SD 11.9); control 66.6 (SD 12.1) Male: 64% White: 86% Inclusion/exclusion criteria Inclusion: EF < 40% or lower in past 2 yr, stable medical regimen, NYHA Class I‐III HF Exclusion: unstable angina, MI or major surgery in past 3 months; history of cardiac arrest in the past 6 months, history of cardiac resynchronisation therapy in the past 3 months; unstable serious ventricular arrhythmias; unstable structural valve disease; current participation in conventional CR programme; diagnosis of peripartum cardiomyopathy within the preceding 6 months; inability to perform a bicycle stress test; lower extremity amputation or other inability to ambulance owing to condition other than HF; severe cognitive dysfunction (Mini‐Mental State Examination score ≤ 24); inability to speak English and regular practice of Tai Chi |
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| Interventions |
Exercise:Total duration: 12 wk Aerobic/resistance/mix: aerobic Frequency: 2 sessions/wk (for 12 wk) and encouraged to practice at home at least 3 times/wk Duration: 1 hr class (30 min warm‐up) Intensity: not reported Modality: Tai Chi movements 1. Wk 2‐5: warm‐up + raising the power, withdraw and push 2. Wk 6‐9: 1 + grasp sparrow's tail, brush knee twist step 3. Wk 10‐12: 2 + wave hands like clouds Participants were given 45‐min instructional videotape that outlined the exercises presented in class as an aid to practice Participants also received same educational pamphlets used in education (control) group with a brief (< 5 min) explanation towards end of 1 Tai Chi session weekly Setting: centre‐based and home‐based Other: none reported |
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| Outcomes | HRQoL (MLWHFQ), mortality, hospital admission | |
| Comparison | Education group ('attention control'): nurse practitioner lead education session (same duration and frequency as the Tai Chi group classes) Participants were asked not to start Tai Chi classes during the study |
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| Country and setting | USA Multisite |
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| Follow‐up | 12 wk and 6 months (after randomisation) | |
| Notes | Single blind | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The trial uses a permuted block randomization with variable block size to generate treatment assignment" |
| Allocation concealment (selection bias) | Unclear risk | "Patients who chose to were randomly assigned to receive a 12‐week tai chi exercise program or a heart health education program (attention control)" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "We masked all the study staff performing all tests to each participant's group allocation" |
| Selective reporting (reporting bias) | Low risk | All outcomes described in methods reported in results |
| Intention‐to‐treat analysis? | Low risk | All participants were included in the analysis regardless of their attendance |
| Incomplete outcome data? | Low risk | Figure 1 of the publication shows 91% to 96% complete data across HRQoL and exercise outcomes |
| Groups balanced at baseline? | Low risk | "The 2 groups were generally similar in demographics, clinical classification of heart disease severity, and rates of comorbidities" |
| Groups received same intervention? | Low risk | Yes, both groups received comprehensive disease management |
AF: atrial fibrillation; bpm: beats/minute; CBT: cognitive behavioural therapy; CHF: chronic heart failure; CONSORT: CONsolidated Standards of Reporting Trials; COPD: chronic obstructive pulmonary disease; CR: cardiac rehabilitation; DCM: dilated cardiomyopathy; DM: diabetes mellitus; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition; EF: ejection fraction; HADS: Hospital Anxiety and Depression Scale; HF: heart failure; hr: hour; HR: heart rate; HRQoL: health‐related quality of life; ITT: intention to treat; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEF: left ventricular ejection fraction; LVSD: left ventricular systolic dysfunction; max: maximum; MI: myocardial infarction; min: minute; MOS: Medical Outcomes Survey; MLWHFQ: Minnesota Living with Heart Failure Questionnaire; MRI: magnetic resonance imaging; NYHA: New York Heart Association; PVD: peripheral vascular disease; RCT: randomised controlled trial; SD: standard deviation; SE: standard error; SF‐36: 36‐item Short Form; VO2: oxygen consumption; wk: week; yr: year.