Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement (REHAB-TAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805309
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Hebrew SeniorLife
National Institute on Aging (NIA)
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Dae Hyun Kim, Brigham and Women's Hospital

Brief Summary:
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. Despite symptomatic and survival benefits, many patients experience functional decline after TAVR. This pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after TAVR.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Behavioral: Exercise Behavioral: Cognitive behavioral interventions Behavioral: Attention control education program Not Applicable

Detailed Description:
We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after TAVR.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : May 6, 2020
Actual Study Completion Date : May 6, 2020


Arm Intervention/treatment
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
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.

Behavioral: Cognitive 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.

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
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.

Active Comparator: Attention Control Education Program
Participants will receive telephone-based education sessions from a study health professional.
Behavioral: Attention 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 Outcome Measures :
  1. Change in the Late-Life Function and Disability Instrument (LLFDI) Score [ Time Frame: At baseline and week 8 ]
    The 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: 0-100).


Secondary Outcome Measures :
  1. Change in the Short Physical Performance Battery (SPPB) Summary Score [ Time Frame: At baseline and week 8 ]
    The summary score is calculated based on chair stands, walking speed, and standing balance (range: 0-12).

  2. Change in the 2-Minute walk distance (meters) [ Time Frame: At baseline and week 8 ]
    The 2-minute walk distance measures endurance.

  3. Change in dominant hand grip strength (kg) [ Time Frame: At baseline and week 8 ]
    Dominant hand grip strength measures upper extremity strength.

  4. Number of participants who experienced adverse events [ Time Frame: At week 8 ]

Other Outcome Measures:
  1. Change in Mini-Mental State Examination (MMSE) score [ Time Frame: At baseline and week 8 ]
    MMSE is an instrument that assesses general cognitive function.

  2. Change in New York Heart Association (NYHA) functional class [ Time Frame: At baseline and week 8 ]
    NYHA assesses the extent of physical activity limitation due to heart failure.

  3. Change in the Self-Efficacy Scale for Exercise (SEE) [ Time Frame: At baseline and week 8 ]
    The SEE scale measures self-efficacy about exercise (range: 0-90).

  4. Change in the Outcome Expectation Scale for Exercise (OEE) [ Time Frame: At baseline and week 8 ]
    The OEE scale measures outcome expectation about exercise (range: 1-5).

  5. Adherence to the home-based exercise program [ Time Frame: At week 8 ]
    The proportion of days with completed daily task during the entire study period will be measured.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 65 years
  • Underwent transcatheter aortic valve replacement
  • Lives within 20-mile radius of the recruiting site
  • Plan to be discharged home
  • Able to provide informed consent

Exclusion Criteria:

  • Stroke or any other medical disease that precludes participation in the exercise program
  • Severe cognitive impairment (Mini-Mental State Examination < 15)
  • Current enrollment in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805309


Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Hebrew SeniorLife
Boston, Massachusetts, United States, 02131
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
Hebrew SeniorLife
National Institute on Aging (NIA)
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dae Hyun Kim, MD, MPH, ScD Beth Israel Deaconess Medical Center
Layout table for additonal information
Responsible Party: Dae Hyun Kim, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02805309    
Other Study ID Numbers: 2017P000106
P30AG031679 ( U.S. NIH Grant/Contract )
P30AG048785 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dae Hyun Kim, Brigham and Women's Hospital:
Transcatheter Aortic Valve Replacement
Exercise
Frailty
Functional Outcomes
Cognitive Behavioral Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction