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Completed

NCT Number: NCT05398744

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Exercise Program

Other

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

Primary outcomes

  1. Study feasibility assessed by participation in training sessions

    Time frame: 16 weeks

    Attendance at assigned training sessions

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

    Time frame: 24 weeks

    Days of logged activity on the MyHeart application

  3. Study feasibility assessed by participants' engagement with exercise physiologist

    Time frame: 24 weeks

    Participants' attendance at biweekly meetings with exercise physiologist

Secondary outcomes

  1. Physical activity of participants

    Time frame: 24 weeks

    Time spent at target heart rate

  2. Health Related Quality of life

    Time frame: 24 weeks

    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.

  3. Psychological well-being

    Time frame: 24 weeks

    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.

  4. Perceived exercise barriers or exercise barriers

    Time frame: 24 weeks

    Exercise barriers will be measured by analysis of survey responses related to physical activity practices

  5. Participants' overall program satisfaction

    Time frame: 24 weeks

    Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Acronym: MIGHTEE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2022
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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