DANREHAB 2008

Methods	Parallel group RCT
Participants	N randomised: 91 (exercise 45; control 46) Age (yr): exercise: median 66 (range 33‐91); control median (range 29‐94) Male: 90% White: not reported Inclusion/exclusion criteria Inclusion: present symptoms of CHF and objective findings or effect of medication Exclusion: mental disorders and social problems (such as dementia, alcoholism or drug addiction). Transferred to other department or hospital at discharge. Severe illness, including NYHA Class IV. Living at nursing home. Did not speak Danish. Refused consent
Interventions	Exercise:Total duration: 12 wk Aerobic/resistance/mix: mix Frequency: 3 sessions/wk Duration: 90 min/session Intensity: 50% max HR Modality: not reported Setting: supervised centre‐based plus home‐based also encouraged to continue Other: the physical exercise was conducted as a mixture of endurance and strengthening training using various upper and lower body modalities easily implemented as activities that the participants could perform at home. CR included participant education, exercise training, dietary counselling, smoking cessation, psychosocial support, and risk factor management and clinical assessment. All components included theoretical and practical approaches followed by individual follow‐up and feedback. The lifestyle intervention strategy was based on the stages of change model and self efficacy theory. The lifestyle intervention was designed as group intervention, but individual counselling was included
Outcomes	Primary: composite outcome measure included overall mortality, MI or acute first‐time re‐admission due to heart disease other than MI Secondary: collected data using an adapted standardised interview questionnaire and a postal questionnaire (e.g. SF‐36, HADS), clinical examination and blood tests
Comparison	Usual care participants were offered follow‐up treatment prescribed by the discharging physician either as outpatient control or by the general practitioner. The pharmaceutical treatment followed routine clinical practice based on current national guidelines. The discharging nurse or physician determined whether participants were referred to smoking cessation and dietary counselling parallel to outpatient treatment
Country and setting	Demark Single centre
Follow‐up	12‐months
Notes	HF subset of 770 participants randomised, other participants with coronary heart disease and were high risk but no disease. Randomisation stratified by indication
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patients who gave informed consent were randomized using a centralized randomization procedure administered by the Copenhagen Trial Unit. The randomization was stratified according to risk group (CHF, IHD, or HR) based on a random‐permuted multiblock within‐stratum method"
Allocation concealment (selection bias)	Low risk	As above
Blinding (performance bias and detection bias) All outcomes	Low risk	"Because of the nature of CR, the interventions were open to the investigators and the patients. Investigator independent outcome data from registries were chosen to ensure blinded assessment and outcome analysis"
Selective reporting (reporting bias)	Low risk	All outcomes listed in methods reported in results
Intention‐to‐treat analysis?	Low risk	ITT analysis stated
Incomplete outcome data?	Low risk	81% overall follow‐up at 12‐months
Groups balanced at baseline?	Low risk	"Patients were well matched at entry"
Groups received same intervention?	Low risk	Both groups received control care