Survivorship Post-HCT Optimization Program
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.
Conditions:
🦠 Hematologic Malignancy
🗓️ Study Start (Actual) 2 December 2022
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. ≥18 years old
    • 2. English speaking
    • 3. Within 90 ± 30 days post allogenic HCT
    • Inclusion Criteria:

      • 1. ≥18 years old
      • 2. English speaking
      • 3. Providing post-discharge care for the patient who has undergone HCT

      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.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2022
  • First Submitted that Met QC Criteria 11 February 2022
  • First Posted 14 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 April 2024
  • Last Update Posted 19 April 2024
  • Last Verified April 2024