Gary 2010 (comp)

Methods	Parallel group RCT
Participants	N Randomised: 28 (CBT 10; CBT and exercise 18) Diagnosis (% of participants): Aetiology: not reported NYHA: Class II 43.3%; Class III 56.7% (as a whole) LVEF: ≥ 15% Case mix: 100% as above Age (yr): 65.8 (SD 13.5) Male: 41.9% White: not reported Inclusion/exclusion criteria Inclusion: 1. documented medical diagnosis of HF; 2. LVEF ≥ 15% documented within the last year by echocardiogram, cardiac catheterisation ventriculography or radionuclide ventriculography; 3. receiving therapy for HF according to guidelines published by the American College of Cardiology American Heart recommendations (angiotensin‐converting enzyme inhibitors, diuretics, beta‐blockers, angiotensin receptor blockers, hydralazine and nitrate combination, etc.); 4. Hamilton Rating Scale for Depression (HAM‐D) score ≥ 11; 5. positive results on the Mini International Neuropsychiatric Interview (Mini) for minor or major depression and 6. DSM‐IV diagnosis for depression for 14 days; or 7 days if history of major depressive disorder in the last 6 months. Participants also had to be 1. English speaking, 2. living independently (non‐institutionalised) within 100 miles of Atlanta, GA, 3. able to respond to questions appropriately, 4. able to hear adequately to respond to verbal questions, 5. not involved in any structured exercise programme or walking 3 times/wk for a minimum of 20 min, 6. not participating in any psychotherapy and 7. not hospitalised within the last 60 days Exclusion: 1. suicide ideation according to psychiatric assessment or Mini evaluation; 2. major psychiatric co‐morbidity such as schizophrenia, personality disorder or dementia; 3. planned surgery; 4. not diagnosed with HF in the past 3 months; 5. renal insufficiency (serum creatinine >2.5 mg/dL); 6. uncontrolled hypertension; 7. acute bereavement or loss of significant other within the last month or currently involved in family crisis such as divorce; 8. any disorder interfering with independent ambulation; and 9. terminal illness such as cancer
Interventions	Exercise:Total duration: 12 wk Aerobic/resistance/mix: aerobic Frequency: 3 sessions/wk Duration: 30‐45 min/session, max 1 hr Intensity: Borg < 15 ('moderate') Modality: walking Setting: home‐based Other: exercise + CBT group also received 12 wk weekly 1‐hr sessions of CBT for 12 wk. No other co‐interventions mentioned
Outcomes	HRQoL (MLWHFQ) and mortality
Comparison	Usual care "Participants assigned to the UC [usual care] group received no information or counselling from their health care provider other than that normally provided"
Country and setting	USA Single‐centre
Follow‐up	24 wk (after randomisation)
Notes	Exercise group participants had 12 weekly face‐to‐face home visits by research nurse to monitor walking progress and to tailor the exercise prescription. "At the first home visit for EX, the research nurse (1) educated the patient on the rationale for EX in HF; (2) instructed on self‐monitoring of symptoms [dyspnea, heart rate (HR), fatigue] during walking; (3) provided the patient with a Polar monitor and instruction on how to use it; (4) provided patient with EX logs and instructions; (5) instructed on use of the 6‐ to 20‐point Borg's rate of perceived exertion (RPE) scale; (6) provided patient with blood pressure cuff and weight scale, if not available; and (7) observed participant response to walking out side home"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	"Data collectors were blinded to group assignment"
Selective reporting (reporting bias)	Low risk	Outcome described in methods are reported in results
Intention‐to‐treat analysis?	Low risk	Although not stated, CONSORT diagram suggests groups analysed according to initial randomised allocation
Incomplete outcome data?	Low risk	QUORUM diagram and details of losses to follow‐up reported. In exercise group, 1 patient died and 3 withdrew at 24 wk. In usual care group, 2 participants and 1 participant withdraw at 12 and 24 wk, respectively. In combined CBT/exercise group 2 withdrew at 12 wk. 1 lost to follow‐up and 1 withdrew at 24 wk. In CBT group, 1 withdrew at 12 wk and 24 wk. 1 died and 1 lost to follow‐up at 24 wk
Groups balanced at baseline?	Low risk	"There were no BL differences between groups on any demographic or outcome variables"
Groups received same intervention?	Low risk	Groups appeared to receive same care other that exercise and CBT interventions