The Effect of High-intensity Interval Training (HIIT) and Resistance Training on Function, Health, and Quality of Life Outcomes Following Hematopoietic Stem Cell Transplant

Duke University1 site in 1 country16 target enrollmentDecember 2, 2022

ConditionsHematologic Malignancy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hematologic Malignancy
Sponsor: Duke University
Enrollment: 16
Locations: 1
Primary Endpoint: Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2, 2022

End Date

March 23, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥18 years old
•English speaking
•Within 90 ± 30 days post allogenic HCT
•Caregiver Inclusion Criteria:
•≥18 years old
•English speaking
•Providing post-discharge care for the patient who has undergone HCT
•Patient and Caregiver

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

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

Time Frame: 12 weeks

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

Time Frame: 12 weeks

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

Time Frame: 12 weeks

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

Time Frame: 12 weeks

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

Time Frame: 12 weeks

Secondary Outcomes

Change in physical function/activity, as measured by SPPB(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by CPET(Baseline, Post-intervention (week 12), 1 Year)
Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)(Baseline, Post-intervention (week 12), 1 Year)
Change in mental health, as measured by PHQ-9(Baseline, Post-intervention (week 12), 1 Year)
Change in mental health, as measured by PROMIS Anxiety(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by PCL-5(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by subcutaneous fat layer thickness(Baseline, Post-intervention (week 12), 1 Year)
Change in cognitive function, as measured by PROMIS Cognitive Function(Baseline, Post-intervention (week 12), 1 Year)
Change in mental health, as measured by PROMIS Depression(Baseline, Post-intervention (week 12), 1 Year)
Change in social support, as measured by Brief Resilience Scale(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by PHQ-2(Baseline, Post-intervention (week 12), 1 Year)
Change in biomarkers of inflammation and frailty, as measured by blood plasma samples(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by PROMIS Depression(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 PROMIS Physical Function(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by bioelectrical impedance (BIA)(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)(Baseline, Post-intervention (week 12), 1 Year)
Change in cognitive function, as measured by RBANS(Baseline, Post-intervention (week 12), 1 Year)
Change in cognitive function, as measured by Brief Cope(Baseline, Post-intervention (week 12), 1 Year)
Change in diet/nutrition, as measured by PG-SGA/Clinician SGA(Baseline, Post-intervention (week 12), 1 Year)
Change in social support, as measured by PROMIS Emotional Support(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by Preparedness for Caregiving assessment(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)
Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)(Baseline, Post-intervention (week 12), 1 Year)
Change in cognitive function, as measured by Trail making test(Baseline, Post-intervention (week 12), 1 Year)
Change in mental health, as measured by PC-PTSD/PCL-5(Baseline, Post-intervention (week 12), 1 Year)
Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)(Baseline, Post-intervention (week 12), 1 Year)
Change in diet/nutrition, as measured by Food Security(Baseline, Post-intervention (week 12), 1 Year)
Change in social support, as measured by CFC-14(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by PROMIS Anxiety(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by PROMIS Emotional Support(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by muscle thickness(Baseline, Post-intervention (week 12), 1 Year)
Change in physical function/activity, as measured by muscle area(Baseline, Post-intervention (week 12), 1 Year)
Change in diet/nutrition, as measured by ASA-24(Baseline, Post-intervention (week 12), 1 Year)
Change in social support, as measured by PROMIS Social Isolation(Baseline, Post-intervention (week 12), 1 Year)
Change in social support, as measured by Lorig Self Efficacy(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by Caregiver Strain index(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by FACT-GP(Baseline, Post-intervention (week 12), 1 Year)
Change in caregiver support, as measured by Ego Resiliency(Baseline, Post-intervention (week 12), 1 Year)
Change in microbiota diversity, as measured by stool samples(Baseline, Post-intervention (week 12), 1 Year)
Transplant length of stay (in days), as measured by medical record review(1 year)
Change in caregiver support, as measured by PROMIS Social Isolation(Baseline, Post-intervention (week 12), 1 Year)
Change in microbiota diversity, as measured by skin swabs(Baseline, Post-intervention (week 12), 1 Year)
Overall survival, as measured by medical record review(1 year)
Disease-free survival, as measured by medical record review(1 year)
Rate of fungal infection, as measured by medical record review(1 year)
Rate of overall infection, as measured by medical record review(1 year)
Rate of hospital admission, as measured by medical record review(1 year)
Intensive care unit length of stay, as measured by medical record review(1 year)
Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review(1 year)
Number of falls, as assessed by Falls questionnaire(1 year)
Change in quality of life, as assessed by OARS IADL assessment(Baseline, Post-intervention (12 weeks), 1 Year)
Rate of bacterial infection, as measured by medical record review(1 year)
Rate of intensive care unit admission, as measured by medical record review(1 year)
Change in quality of life, as assessed by EQ-5D-5L assessment(Baseline, Post-intervention (12 weeks), 1 Year)
Rate of viral infection, as measured by medical record review(1 year)
Hospital length of stay, as measured by medical record review(1 year)
Number of subjects who experienced delirium, as assessed by DOS assessment(1 year)
Number of patients who returned to work, as assessed by Work Assessment(1 year)
Change in quality of life, as assessed by FACT-BMT assessment(Baseline, Post-intervention (12 weeks), 1 Year)