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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Orthotopic Heart Transplant
• Intervention / Treatment: Other: Group Exercise Program

Detailed Description

Orthotopic heart transplant (OHT) is the definitive therapy for children with cardiac disease, however, survival after transplant is limited, and quality of life after transplant is less than healthy peers'. The transplanted heart usually works well, pumping blood as well as most healthy hearts. As such, the American Heart Association recommends no specific exercise related restrictions for heart transplant recipients. Although most children have normal cardiac function after OHT, children with transplanted hearts have impaired exercise performance, and do not exercise as much as their peers. This finding is concerning, as impaired exercise tolerance is associated with reduced survival, diminished health related quality of life, and depression and anxiety. These factors negatively impact adherence, and further limit graft survival. Thus, identifying interventions that positively impact physical activity and promote graft longevity, like individualized exercise programs, should be a priority for post-transplant care.

Investigators propose that increasing physical activity in children and adolescents after OHT may be a critical modifiable method for increasing graft longevity and improving quality of life. Investigators will explore this through a pilot program. Participants will wear an activity monitor to record physical activity, parents/caregivers and participants will complete surveys, and participants will engage with psychologists and exercise physiologists.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Patients

• 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

Exclusion Criteria for Patients

• 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

Inclusion Criteria for Parents

• Parent of a patient that fits all inclusionary/exclusionary eligibility criteria
• 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

Exclusion Criteria for Parents

- Unwilling to complete questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual group aerobic training program; 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; At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity of participants	Time spent at target heart rate	24 weeks
Health Related Quality of life	Health related quality of life (HRQL) will be measured by participants' responses to Pediatric Quality of Life (PEDSQL) questionnaire, generating scores from 0-100 with a higher score indicating better quality of life.	24 weeks
Psychological well-being	Psychological well-being will be evaluated by participants' responses on questionnaires using Patient Reported Outcome Measurement Information System (PROMIS). PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population) with a higher score indicating more of the psychological concept being measured.	24 weeks
Perceived exercise barriers or exercise barriers	Exercise barriers will be measured by analysis of survey responses related to physical activity practices	24 weeks
Participants' overall program satisfaction	Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires	24 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jonathan Edelson, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Motivational interviewing; Aerobic Exercise; OHT; Group Exercise
• Other Study ID Numbers: 21-018888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No