Orthotopic Heart TransplantMIGHTEENCT05398744
Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
A study testing Group Exercise Program in people with Orthotopic Heart Transplant, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthotopic Heart Transplant
- What is being tested?
- Group Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- English language proficiency
- 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
Who cannot join
- 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
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- 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
- Unwilling to complete questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthotopic Heart Transplant
- Being tested
- Group Exercise Program
- Keywords
- OHT, Aerobic Exercise, Motivational interviewing, Group Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Exercise ProgramOther
At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Group Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility assessed by participation in training sessions
Attendance at assigned training sessions
Measured: 16 weeks
Study feasibility evaluated by participants' engagement on the activity monitor application
Days of logged activity on the MyHeart application
Measured: 24 weeks
Study feasibility assessed by participants' engagement with exercise physiologist
Participants' attendance at biweekly meetings with exercise physiologist
Measured: 24 weeks
Secondary outcomes (5)
Physical activity of participants
Time spent at target heart rate
Measured: 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.
Measured: 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.
Measured: 24 weeks
Perceived exercise barriers or exercise barriers
Exercise barriers will be measured by analysis of survey responses related to physical activity practices
Measured: 24 weeks
Participants' overall program satisfaction
Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start13 Jul 2022
- Primary completion6 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthotopic Heart TransplantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Edelson, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398744
- Sponsor's protocol ID
- 21-018888
- Acronym
- MIGHTEE
- Status last verified
- Sep 2024
- First submitted
- 26 May 2022
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIGHTEE: Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
- ClinicalTrials.gov ID
- NCT05398744
- Acronym / sponsor ID
- MIGHTEE / 21-018888
- Conditions
- Orthotopic Heart Transplant
- Keywords
- OHT, Aerobic Exercise, Motivational interviewing, Group Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual group aerobic training program | Experimental | Other: Group Exercise Program16-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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Exercise ProgramAt-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks. | Other | Virtual group aerobic training program |
Primary outcome
Study feasibility assessed by participation in training sessions
Time frame: 16 weeks
Attendance at assigned training sessions
Study feasibility evaluated by participants' engagement on the activity monitor application
Time frame: 24 weeks
Days of logged activity on the MyHeart application
Study feasibility assessed by participants' engagement with exercise physiologist
Time frame: 24 weeks
Participants' attendance at biweekly meetings with exercise physiologist
5 secondary outcomes
Physical activity of participants
Time frame: 24 weeks
Health Related Quality of life
Time frame: 24 weeks
Psychological well-being
Time frame: 24 weeks
Perceived exercise barriers or exercise barriers
Time frame: 24 weeks
Participants' overall program satisfaction
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Edelson, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Exercise Program in people with Orthotopic Heart Transplant, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility assessed by participation in training sessions (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.