| Study name |
Home‐based exercise program for recovery after transcatheter aortic valve replacement: a pilot study |
| Methods |
Parallel‐assignment RCT |
| Participants |
Older adults after TAVR |
| Interventions |
Experimental: exercise and cognitive‐behavioural intervention. A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualised exercise programme and cognitive‐behavioural interventions
Experimental: exercise alone. A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualised exercise programme, without cognitive‐behavioural interventions
Active comparator: attention control education programme. Participants will receive telephone‐based education sessions from a study health professional |
| Outcomes |
Primary outcome measure
Change in Late‐Life Function and Disability Instrument (LLFDI) score [Time Frame: at baseline and at Week 8, LLFDI is a validated patient‐reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks) and disability (inability to perform major life tasks and social roles) (range 0 to 100)]
Secondary outcome measures
Change in Short Physical Performance Battery (SPPB) summary score [Time Frame: at baseline and at Week 8, summary score is calculated based on chair stands, walking speed, and standing balance (range 0 to 12)] Change in 2‐minute walk distance (meters) [Time Frame: at baseline and at Week 8, 2‐minute walk distance measures endurance] Change in dominant handgrip strength (kg) [Time Frame: at baseline and at Week 8, dominant handgrip strength measures upper extremity strength] Number of participants who experienced adverse events [Time Frame: at Week 8]
Other outcome measures
Change in Mini‐Mental State Examination (MMSE) score [Time Frame: at baseline and at Week 8, MMSE is an instrument that assesses general cognitive function] Change in New York Heart Association (NYHA) functional class [Time Frame: at baseline and at Week 8, NYHA assesses the extent of physical activity limitation due to heart failure] Change in Self‐Efficacy Scale for Exercise (SEE) [Time Frame: at baseline and at Week 8, SEE Scale measures self‐efficacy about exercise (range 0 to 90)] Change in Outcome Expectation Scale for Exercise (OEE) [Time Frame: at baseline and at Week 8, OEE Scale measures outcome expectation about exercise (range 1 to 5)] Adherence to home‐based exercise programme [Time Frame: at Week 8, proportion of days with completed daily task during entire study period will be measured]
|
| Starting date |
1 August 2017 |
| Contact information |
Dae Hyun Kim, Associate Physician, Brigham and Women's Hospital |
| Notes |
Estimated enrolment: 60 participants. Estimated study completion date: 31 May 2020
Location: United States, Massachusetts |
