Exercise program for improving health after stem cell transplant
The Effect of High-intensity Interval Training (HIIT) and Resistance Training on Function, Health, and Quality of Life Outcomes Following Hematopoietic Stem Cell Transplant
This study tests whether a 12-week exercise program can help people feel better and improve their health after having a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05238376 on ClinicalTrials.gov |
What this trial studies
This project investigates the effects of a 12-week high-intensity interval training (HIIT) and resistance training program on various health domains in patients who have undergone hematopoietic stem cell transplant (HCT). The study aims to assess improvements in physical function, cognitive function, mental health, and quality of life for patients, as well as the impact on caregiver strain and confidence. Participants will be monitored for safety through cardiopulmonary exercise testing to ensure they can safely engage in the exercise regimen.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are within 90 days post-allogenic HCT and are English-speaking.
Not a fit: Patients with absolute contraindications to exercise or significant cardiac issues may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly enhance the overall health and quality of life for patients recovering from hematologic malignancies.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in similar patient populations, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: 1. ≥18 years old 2. English speaking 3. Within 90 ± 30 days post allogenic HCT Caregiver Inclusion Criteria: 1. ≥18 years old 2. English speaking 3. Providing post-discharge care for the patient who has undergone HCT Patient and Caregiver Exclusion Criteria: 1. 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. 2. 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.
Where this trial is running
Durham, North Carolina
- Duke Adult Blood and Marrow Transplant Clinic — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Chenyu Lin, MD — Duke University
- Study coordinator: Lauren Hill, BS
- Email: lauren.bohannon@duke.edu
- Phone: 919-668-2369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.