Survivorship Post-HCT Optimization Program

NCT05238376 | Completed DMC

• 1 other identifier: Pro00110028
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (6)

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Secondary Outcomes (62)

• Change in physical function/activity, as measured by SPPB

  Baseline, Post-intervention (week 12), 1 Year

• Change in physical function/activity, as measured by 6-minute walk test

  Baseline, Post-intervention (week 12), 1 Year

• Change in physical function/activity, as measured by 30-second sit-to-stand

  Baseline, Post-intervention (week 12), 1 Year

• Change in physical function/activity, as measured by grip strength

  Baseline, Post-intervention (week 12), 1 Year

• Change in physical function/activity, as measured by Fried Frailty

  Baseline, Post-intervention (week 12), 1 Year

Study Arms (2)

Patient

EXPERIMENTAL

These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.

Behavioral: Exercise training

Caregiver

EXPERIMENTAL

These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

12 weeks of high intensity interval training (HIIT) (3x/week) and resistance training (2x/week)

Caregiver; Patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Adult Blood and Marrow Transplant Clinic

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chenyu Lin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: December 2, 2022
• Primary Completion: February 26, 2025
• Study Completion: March 23, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)