Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study

NCT05398744 | Completed

• 1 other identifier: 21-018888
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this 16-week group aerobic training program, delivered remotely via video-conferencing, is to assess program feasibility, and determine if program increases physical activity in adolescents after heart transplant.

Conditions

Orthotopic Heart Transplant

Keywords

OHT; Aerobic Exercise; Motivational interviewing; Group Exercise

Outcome Measures

Primary Outcomes (3)

• Study feasibility assessed by participation in training sessions

  Attendance at assigned training sessions

  16 weeks

• Study feasibility evaluated by participants' engagement on the activity monitor application

  Days of logged activity on the MyHeart application

  24 weeks

• Study feasibility assessed by participants' engagement with exercise physiologist

  Participants' attendance at biweekly meetings with exercise physiologist

  24 weeks

Secondary Outcomes (5)

• Physical activity of participants

  24 weeks

• Health Related Quality of life

  24 weeks

• Psychological well-being

  24 weeks

• Perceived exercise barriers or exercise barriers

  24 weeks

• Participants' overall program satisfaction

  24 weeks

Study Arms (1)

Virtual group aerobic training program

EXPERIMENTAL

16-week, virtual group aerobic training program led by exercise physiologist. Duration: 24 weeks. Four weeks recording of baseline activity through activity monitor; 16-week virtual group aerobic training program, 3 times per week for 30 minutes; and four weeks of follow-up.

Other: Group Exercise Program

Interventions

Group Exercise Program OTHER

At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.

Virtual group aerobic training program

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-18 years old
• More than 12 months removed from their initial heart transplant
• Agreement to participate in study protocol and willing/able to return for follow-up.
• Access to computer and/or internet for uploading health data from wearable electronic activity monitor.
• Access to an electronic device (phone, tablet, or computer) with a camera feature, microphone, and the capacity to use Zoom, the virtual platform which will stream the group exercise session.
• Clinical EKG with normal sinus rhythm
• English language proficiency

You may not qualify if:

• Patients who are restricted from exercise
• Patients who are pregnant
• History of pharmaceutically treated rejection within the prior 6 months
• Physical or behavioral conditions that would prevent them from participating in aerobic exercise (i.e., significant motor disability, illness precluding participation in the exercise regimen as described).
• Inability to complete a standard maximal exercise stress test (as defined by those who did not achieve an respiratory exchange ratio (RER)\>1.1 and who gave submaximal effort according to exercise physiologist performing EST)
• EKG or ambulatory rhythm monitor performed within the last 12 months which shows 2nd or 3rd degree atrioventricular (AV) block
• Patients with a medication change after their baseline EST expected to affect their heart rate response to exercise (i.e. initiation/discontinuation of a beta-blocker, beta-agonist during exercise, or ivabradine)
• Pacemaker
• English language proficiency at least at a 5th grade level or for limited English proficient (LEP) parents, preferred language proficiency of at least a 5th grade level
• \- Unwilling to complete questionnaires

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Jonathan Edelson, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: July 13, 2022
• Primary Completion: June 6, 2024
• Study Completion: June 26, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)