Clinical trial NCT05238376: Survivorship Post-HCT Optimization Program
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Adherence to prescribed exercise program, as measured by number of total sessions completed
timeFrame: 12 weeks
measure: Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)
timeFrame: 12 weeks
measure: Compliance to prescribed HIIT sessions, as measured by number of intervals completed
timeFrame: 12 weeks
measure: Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates
timeFrame: 12 weeks
measure: Compliance to prescribed resistance sessions, as measured by number of sets completed
timeFrame: 12 weeks
measure: Compliance to prescribed resistance sessions, as measured by number of repetitions completed
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in physical function/activity, as measured by SPPB
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by 6-minute walk test
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by 30-second sit-to-stand
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by grip strength
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by Fried Frailty
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by PROMIS Physical Function
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by bioelectrical impedance (BIA)
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by CPET
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by muscle thickness
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by muscle area
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in physical function/activity, as measured by subcutaneous fat layer thickness
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in cognitive function, as measured by PROMIS Cognitive Function
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in cognitive function, as measured by RBANS
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in cognitive function, as measured by Trail making test
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in cognitive function, as measured by Brief Cope
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in mental health, as measured by PHQ-9
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in mental health, as measured by PC-PTSD/PCL-5
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in mental health, as measured by PROMIS Depression
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in mental health, as measured by PROMIS Anxiety
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in diet/nutrition, as measured by PG-SGA/Clinician SGA
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in diet/nutrition, as measured by ASA-24
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in diet/nutrition, as measured by Food Security
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in social support, as measured by PROMIS Emotional Support
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in social support, as measured by PROMIS Social Isolation
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in social support, as measured by Lorig Self Efficacy
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in social support, as measured by CFC-14
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in social support, as measured by Brief Resilience Scale
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by Caregiver Strain index
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by Preparedness for Caregiving assessment
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by FACT-GP
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PHQ-2
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PCL-5
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by Ego Resiliency
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PROMIS Depression
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PROMIS Anxiety
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PROMIS Emotional Support
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in caregiver support, as measured by PROMIS Social Isolation
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in microbiota diversity, as measured by skin swabs
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in microbiota diversity, as measured by stool samples
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Change in biomarkers of inflammation and frailty, as measured by blood plasma samples
timeFrame: Baseline, Post-intervention (week 12), 1 Year
measure: Overall survival, as measured by medical record review
timeFrame: 1 year
measure: Disease-free survival, as measured by medical record review
timeFrame: 1 year
measure: Rate of bacterial infection, as measured by medical record review
timeFrame: 1 year
measure: Rate of fungal infection, as measured by medical record review
timeFrame: 1 year
measure: Rate of viral infection, as measured by medical record review
timeFrame: 1 year
measure: Rate of overall infection, as measured by medical record review
timeFrame: 1 year
measure: Rate of hospital admission, as measured by medical record review
timeFrame: 1 year
measure: Rate of intensive care unit admission, as measured by medical record review
timeFrame: 1 year
measure: Hospital length of stay, as measured by medical record review
timeFrame: 1 year
measure: Intensive care unit length of stay, as measured by medical record review
timeFrame: 1 year
measure: Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review
timeFrame: 1 year
measure: Transplant length of stay (in days), as measured by medical record review
timeFrame: 1 year
measure: Number of patients who returned to work, as assessed by Work Assessment
timeFrame: 1 year
measure: Number of falls, as assessed by Falls questionnaire
timeFrame: 1 year
measure: Number of subjects who experienced delirium, as assessed by DOS assessment
timeFrame: 1 year
measure: Change in quality of life, as assessed by FACT-BMT assessment
timeFrame: Baseline, Post-intervention (12 weeks), 1 Year
measure: Change in quality of life, as assessed by EQ-5D-5L assessment
timeFrame: Baseline, Post-intervention (12 weeks), 1 Year
measure: Change in quality of life, as assessed by OARS IADL assessment
timeFrame: Baseline, Post-intervention (12 weeks), 1 Year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Adult Blood and Marrow Transplant Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Chenyu Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: