Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

Browse trials for

• Aortic Valve Stenosis 985

Keywords

• Transcatheter Aortic Valve Replacement
• Exercise
• Frailty
• Functional Outcomes
• Cognitive Behavioral Intervention

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 64 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Study arms

• Experimental
  Exercise & Cognitive Behavioral Int.

  A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.

  Behavioral: Exercise · Behavioral: Cognitive behavioral interventions

• Experimental
  Exercise Alone

  A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program, without cognitive behavioral interventions.

  Behavioral: Exercise

• Active comparator
  Attention Control Education Program

  Participants will receive telephone-based education sessions from a study health professional.

  Behavioral: Attention control education program

Interventions

• BehavioralExercise

  Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.

• BehavioralCognitive behavioral interventions

  The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.

• BehavioralAttention control education program

  A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.

Primary outcomes

1. Change in the Late-Life Function and Disability Instrument (LLFDI) Score

   The LLFDI is a validated patient-reported outcome questionnaire that measures both functional limitations (inability to perform physical tasks - Activity Limitation Domain score, range: 0-100) and disability (inability to perform major life tasks and social roles - Participation Restriction Domain score, range: 0-100). For both scales, higher values indicate better function (lower limitation or lower disability). Two domain scores are analyzed separately.

   Time frame: At baseline and week 8

Secondary outcomes

1. Change in the Short Physical Performance Battery (SPPB) Summary Score

   The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12). Higher scores indicate better physical performance.

   Time frame: At baseline and week 8

2. Change in the 2-Minute Walk Distance (Feet)

   The 2-minute walk distance measures endurance. A longer distance indicates better endurance.

   Time frame: At baseline and week 8

3. Change in Dominant Hand Grip Strength (kg)

   Dominant hand grip strength measures upper extremity strength.

   Time frame: At baseline and week 8

4. Number of Participants Who Experienced Adverse Events

   Number of participants who experience any adverse events and serious adverse events

   Time frame: At week 8

Other outcomes

1. Change in Mini-Mental State Examination (MMSE) Score

   MMSE is an instrument that assesses general cognitive function (range: 0 to 30). Higher scores indicate better cognitive function.

   Time frame: At baseline and week 8

2. Change in New York Heart Association (NYHA) Functional Class

   NYHA assesses the extent of physical activity limitation due to heart failure. It ranges from 1 (ordinary physical activity does not cause symptoms) to 4 (symptoms occur at rest).

   Time frame: At baseline and week 8

3. Change in the Self-Efficacy Scale for Exercise (SEE)

   The SEE scale measures self-efficacy about exercise (range: 0-90). Higher values indicate higher self efficacy.

   Time frame: At baseline and week 8

4. Change in the Outcome Expectation Scale for Exercise (OEE)

   The OEE scale measures outcome expectation about exercise (range: 9-45). Higher scores indicate higher expectation.

   Time frame: At baseline and week 8

5. Adherence to the Home-based Exercise Program

   The proportion of days with completed daily task during the entire study period will be measured.

   Time frame: At week 8

Baseline characteristics

5 further baseline measures are reported on the registry.

Publications

• Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3. PubMed 33962483 ↗

Study documents

• Protocol and statistical analysis plan · Mar 9, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No