CompletedNot Applicable

Survivorship Post-HCT Optimization Program

United States16 participantsStarted 2022-12-02

Plain-language summary

The purpose of this project is to investigate the effects of 12 weeks of high-intensity interval training (HIIT) and resistance training on several domains of health including physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant (HCT). In addition, the project will determine the effects of 12 weeks of HIIT and resistance training on physical function, caregiver strain, mental health, and caregiver confidence in individuals who are providing care for patients undergoing HCT.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥18 years old
✓. English speaking
✓. Within 90 ± 30 days post allogenic HCT
✓. ≥18 years old
✓. English speaking
✓. Providing post-discharge care for the patient who has undergone HCT

Exclusion criteria

✕. Have an absolute contraindication to exercise including a recent acute cardiac event (\<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease.
✕. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.

What they're measuring

Adherence to prescribed exercise program, as measured by number of total sessions completed

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by number of intervals completed

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates

Timeframe: 12 weeks

Compliance to prescribed resistance sessions, as measured by number of sets completed

Timeframe: 12 weeks

Compliance to prescribed resistance sessions, as measured by number of repetitions completed

Timeframe: 12 weeks

Trial details

NCT IDNCT05238376

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-26

View on ClinicalTrials.gov More Hematologic Malignancy trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥18 years old
✓. English speaking
✓. Within 90 ± 30 days post allogenic HCT
✓. ≥18 years old
✓. English speaking
✓. Providing post-discharge care for the patient who has undergone HCT

Exclusion criteria

✕. Have an absolute contraindication to exercise including a recent acute cardiac event (\<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease.
✕. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.

What they're measuring

Adherence to prescribed exercise program, as measured by number of total sessions completed

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by number of intervals completed

Timeframe: 12 weeks

Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates

Timeframe: 12 weeks

Compliance to prescribed resistance sessions, as measured by number of sets completed

Timeframe: 12 weeks

Compliance to prescribed resistance sessions, as measured by number of repetitions completed

Timeframe: 12 weeks