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NCT05238376 | RECRUITING | Hematologic Malignancy

Survivorship Post-HCT Optimization Program
Sponsor:

Duke University

Brief 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.

Condition or disease

Hematologic Malignancy

Intervention/treatment

Exercise training

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : The Effect of High-intensity Interval Training (HIIT) and Resistance Training on Function, Health, and Quality of Life Outcomes Following Hematopoietic Stem Cell Transplant
Actual Study Start Date : 2022-12-02
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Survivorship Post-HCT Optimization Program

Location Details

NCT05238376

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

Duke Adult Blood and Marrow Transplant Clinic

Durham, North Carolina, United States, 27705