Figure 1
Outline of study participant allocation.
Table 1
Summary of participant characteristics by enrollment arm.
| VARIABLE | IBCR (N = 25) | HBCR (N = 31) | OA* (N = 44) | P | |||
|---|---|---|---|---|---|---|---|
| Sex, male n (%) | 8 | 32 | 3 | 10 | 17 | 39 | 0.02 |
| Age in years: mean, (SD) | 56 | 17 | 44 | 16 | 54 | 16 | 0.01 |
| Weight in Kgs: pre-rehab mean, (SD) | 73 | 22 | 71 | 17 | 64 | 14 | 0.07 |
| Height in meters: mean, (SD) | 162 | 7 | 163 | 7 | 164 | 9 | 0.55 |
| BMI mean, (SD) | 28 | 8 | 27 | 7 | 24 | 6 | 0.04 |
| Waist circumference in cm: mean, (SD) | 96 | 24 | 91 | 16 | 89 | 14 | 0.25 |
| Hip circumference in cm: mean, (SD) | 106 | 17 | 106 | 13 | 97 | 13 | 0.01 |
| Resting heart rate bpm: mean, (SD) | 71 | 9 | 71 | 15 | 77 | 13 | 0.08 |
| Resting respiratory rate (SD) | 18 | 3 | 18 | 3 | 18 | 3 | 0.58 |
| Systolic BP in mmHg: mean, (SD) | 138 | 17 | 132 | 21 | 132 | 20 | 0.42 |
| Diastolic BP in mmHg: mean, (SD) | 84 | 12 | 79 | 11 | 82 | 12 | 0.19 |
| Ejection fraction% (SD) | 50 | 15 | 49 | 14 | 45 | 15 | 0.29 |
| HF PHENOTYPES | N | % | N | % | N | % | P |
| EF >50% | 16 | 64 | 20 | 65 | 21 | 48 | |
| EF 40-50% | 4 | 16 | 3 | 10 | 7 | 16 | 0.51 |
| EF <40% | 5 | 20 | 8 | 26 | 16 | 36 | |
| Rheumatic heart disease | 4 | 16 | 7 | 23 | 8 | 18 | 0.02 |
| Hypertensive heart disease | 16 | 64 | 13 | 42 | 11 | 25 | |
| Others (Ischemic, peripartum, tuberculous & unknown) | 5 | 20 | 11 | 35 | 25 | 56 | |
| Overall Protocol Adherence% | 46 | 18 | 29 | 11 | . | . | . |
[i] IBCR – institution based cardiac rehabilitation, HBCR – home based cardiac rehabilitation, OA – Observational arm. *- no evaluation of adherence since there was no intervention in the OA arm.
Figure 2
Participant Adherence according to Cardiac rehabilitation model.
Table 2
Summary of changes in functional capacity by study arm among participants who completed follow up*.
| CHANGE IN NYHA CLASS | IBCR | HBCR | OA | P | |||
|---|---|---|---|---|---|---|---|
| FREQ. | PERCENT | FREQ. | PERCENT | FREQ. | PERCENT | FISHER’S | |
| Got worse (+1) | 0 | 0 | 0 | 0 | 3 | 8 | 0.06 |
| No change (0) | 7 | 29 | 16 | 59 | 14 | 38 | |
| Better (–1) | 15 | 63 | 10 | 37 | 20 | 54 | |
| Much better (–2) | 2 | 8 | 1 | 4 | 0 | 0 | |
| CHANGE IN 6MWTD | MEAN(M) | SD | MEAN(M) | SD | MEAN(M) | SD. | ANOVA |
| 6MWTD in meters – initial | 278 | 78 | 292 | 59 | 259 | 68 | 0.13 |
| 6 MWTD in meters – month 1 | 314 | 57 | 315 | 57 | 303 | 58 | 0.64 |
| 6 MWTD in meters – month 2 | 323 | 66 | 331 | 56 | 304 | 59 | 0.23 |
| 6 MWTD in meters – month 3 | 316 | 74 | 339 | 52 | 304 | 80 | 0.16 |
| Change in 6 MWT distance in meters (over 3 months) | 31.25 | 64.98 | 40.15 | 54.68 | 38.24 | 71.42 | 0.88 |
| P (Paired t-test) | 0.027 | <0.001 | 0.0025 | ||||
| Adjusted Change in 6MWTD * | 34 | 27.19 | 45 | 26.06 | 33 | 21.94 | 0.134 |
[i] 6MWTD – six-minute walk time distance; NYHA- New York Heart Association, IBCR – institution based cardiac rehabilitation, HBCR – home based cardiac rehabilitation, OA – Observational arm.
* The study design is underpowered to make comparative effectiveness assessments; sensitivity analysis was conducted adjusting for baseline imbalances in age, gender, BMI, and cause of heart failure.
| 6MWTD | 6-minute Walk Time Distance |
| CR | Cardiac Rehabilitation |
| DSMB | Data Safety and Monitoring Board |
| HBCR | Home Based Cardiac Rehabilitation |
| HR | Heart Rate |
| IBCR | Institution Based Cardiac Rehabilitation |
| IQR | Interquartile Range |
| MTRH | Moi Teaching and Referral Hospital |
| NYHA | New York heart association |
| OA | Observational arm |
| SD | Standard Deviation |