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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
16
12 weeks of high intensity interval training (HIIT) (3x/week) and resistance training (2x/week)
Duke Adult Blood and Marrow Transplant Clinic
Durham, North Carolina, United States
Adherence to prescribed exercise program, as measured by number of total sessions completed
Time frame: 12 weeks
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
Compliance to prescribed resistance sessions, as measured by number of repetitions completed
Time frame: 12 weeks
Change in physical function/activity, as measured by SPPB
All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by 6-minute walk test
The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
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Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by 30-second sit-to-stand
Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by grip strength
The hand grip is an indicator of upper body strength and has been found to be a good predictor of future functional limitations and disabilities. The hand grip score is determined based on how quickly the participant can squeeze the hand dynamometer.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Fried Frailty
The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by PROMIS Physical Function
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by bioelectrical impedance (BIA)
Participants will have body composition assessed by bioelectrical impedance spectroscopy (BIS) via a bioimpedance analysis (BIA) device. BIA equipment does not measure muscle mass directly, but instead derives an estimate of muscle mass based on whole-body electrical conductivity.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by CPET
Exercise capacity will be assessed using a symptom-limited Cardiopulmonary Exercise Test (CPET) on a cycle ergometer or for a six-minute step test with expired gas analysis to determine VO2peak, according to guidelines for clinical populations (Jones et al., 2012). All CPET data will be recorded as the highest 30-second value elicited during the CPET.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMAT.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus. Complex grayscale analysis of the images is used to calculate the IMGC.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by muscle thickness
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by muscle area
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by subcutaneous fat layer thickness
Longitudinal and transverse ultrasound images of the m. rectus femoris, vastus lateralis, m. intercostalis / m. pectoralis, (head) m. temporalis, and/or (head) styloglossus, using greyscale analyses.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)
This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by PROMIS Cognitive Function
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by RBANS
RBANS evaluation produces five index scores as well as a total summary score, and total scaled score. Scores range from 40 to 160, with higher scores indicating better performance (Smith et al., 2014). The scaled score classifies neuropsychological performance as: extremely low (69 and below), borderline (70-79), low average (80-89), average (90-109), high average (110-119), superior (120-129), and very superior (130 and above) (Batty et al., 2016; Randolph et al., 1998).
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Trail making test
Trail Making Test parts A and B (TMT-A and -B) will be used for identification of cognitively impairment. Total time to completion will be used as outcome variable for both parts (ranging from 0 to 300 seconds, with higher scores indicating worse performance (Smith et al., 2014). An adjusted mean T-score also will be calculated ranging from 0 to 100 (mean score 50, higher score indicating better performance). The T-score can be adjusted for age, sex, education and ethnicity.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Brief Cope
Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PHQ-9
The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PC-PTSD/PCL-5
PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PROMIS Depression
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PROMIS Anxiety
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)
PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by PG-SGA/Clinician SGA
Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by ASA-24
ASA-24 is a self-administered 24-hour diet recall
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by Food Security
Participants will be given the USDA food security survey to review their food securities or insecurities. This is a 10 item survey.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by PROMIS Emotional Support
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by PROMIS Social Isolation
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by Lorig Self Efficacy
The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by CFC-14
CFC-14 is a 14 item questionnaire to assess a patient's consideration of immediate and consideration of future consequences
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by Brief Resilience Scale
BRS assesses the patient's ability to recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Caregiver Strain index
Tool to assess strain on long-term caregivers
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Preparedness for Caregiving assessment
Items are scored by calculating the mean of all items with a range of 0-4. The higher the score, the more prepared the caregiver feels to give care.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by FACT-GP
21 item assessment scored on a 5-point Likert scale
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PHQ-2
The PHQ-9 consists of 2 items, each of which is scored 0 to 3, giving a 0 to 6 severity score
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PCL-5
The PCL-5 is a 20 item screen to assess symptoms of PTSD.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Ego Resiliency
14 item survey scored from 0-56, where a higher score indicates higher level of resiliency
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Depression
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Anxiety
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Emotional Support
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Social Isolation
The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in microbiota diversity, as measured by skin swabs
Skin swab samples batch sequenced and microbiome analyzed
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in microbiota diversity, as measured by stool samples
Changes in stool samples as measured by 16s rRNA sequencing
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in biomarkers of inflammation and frailty, as measured by blood plasma samples
Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty
Time frame: Baseline, Post-intervention (week 12), 1 Year
Overall survival, as measured by medical record review
Time frame: 1 year
Disease-free survival, as measured by medical record review
Time frame: 1 year
Rate of bacterial infection, as measured by medical record review
Time frame: 1 year
Rate of fungal infection, as measured by medical record review
Time frame: 1 year
Rate of viral infection, as measured by medical record review
Time frame: 1 year
Rate of overall infection, as measured by medical record review
Time frame: 1 year
Rate of hospital admission, as measured by medical record review
Time frame: 1 year
Rate of intensive care unit admission, as measured by medical record review
Time frame: 1 year
Hospital length of stay, as measured by medical record review
Time frame: 1 year
Intensive care unit length of stay, as measured by medical record review
Time frame: 1 year
Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review
Time frame: 1 year
Transplant length of stay (in days), as measured by medical record review
Time frame: 1 year
Number of patients who returned to work, as assessed by Work Assessment
Time frame: 1 year
Number of falls, as assessed by Falls questionnaire
Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
Time frame: 1 year
Number of subjects who experienced delirium, as assessed by DOS assessment
The Delirium Observation Screening Scale is a 13-item observational scale of verbal and nonverbal behavior. The observations can be done during regular care. The DOS is used to optimize recognition of delirium.
Time frame: 1 year
Change in quality of life, as assessed by FACT-BMT assessment
50 item assessment. Higher total and domain scores indicate greater quality of life.
Time frame: Baseline, Post-intervention (12 weeks), 1 Year
Change in quality of life, as assessed by EQ-5D-5L assessment
The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the "5L," ranging from "no problems" to "extreme problems." All scores are converted into a summary index.
Time frame: Baseline, Post-intervention (12 weeks), 1 Year
Change in quality of life, as assessed by OARS IADL assessment
OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
Time frame: Baseline, Post-intervention (12 weeks), 1 Year