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Completed

NCT Number: NCT05238376

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Adult Blood and Marrow Transplant Clinic

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient 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.

Treatment and study plan

Exercise Training

Behavioral

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

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

Secondary outcomes

  1. Change in physical function/activity, as measured by SPPB

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

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

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

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

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

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

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

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

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  6. Change in physical function/activity, as measured by PROMIS Physical Function

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  7. Change in physical function/activity, as measured by bioelectrical impedance (BIA)

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  8. Change in physical function/activity, as measured by CPET

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  9. Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  10. Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  11. Change in physical function/activity, as measured by muscle thickness

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  12. Change in physical function/activity, as measured by muscle area

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  13. Change in physical function/activity, as measured by subcutaneous fat layer thickness

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  14. Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  15. Change in cognitive function, as measured by PROMIS Cognitive Function

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  16. Change in cognitive function, as measured by RBANS

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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).

  17. Change in cognitive function, as measured by Trail making test

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  18. Change in cognitive function, as measured by Brief Cope

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  19. Change in mental health, as measured by PHQ-9

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score

  20. Change in mental health, as measured by PC-PTSD/PCL-5

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  21. Change in mental health, as measured by PROMIS Depression

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  22. Change in mental health, as measured by PROMIS Anxiety

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  23. Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk

  24. Change in diet/nutrition, as measured by PG-SGA/Clinician SGA

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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)

  25. Change in diet/nutrition, as measured by ASA-24

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    ASA-24 is a self-administered 24-hour diet recall

  26. Change in diet/nutrition, as measured by Food Security

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    Participants will be given the USDA food security survey to review their food securities or insecurities. This is a 10 item survey.

  27. Change in social support, as measured by PROMIS Emotional Support

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  28. Change in social support, as measured by PROMIS Social Isolation

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  29. Change in social support, as measured by Lorig Self Efficacy

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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).

  30. Change in social support, as measured by CFC-14

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    CFC-14 is a 14 item questionnaire to assess a patient's consideration of immediate and consideration of future consequences

  31. Change in social support, as measured by Brief Resilience Scale

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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).

  32. Change in caregiver support, as measured by Caregiver Strain index

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    Tool to assess strain on long-term caregivers

  33. Change in caregiver support, as measured by Preparedness for Caregiving assessment

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  34. Change in caregiver support, as measured by FACT-GP

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    21 item assessment scored on a 5-point Likert scale

  35. Change in caregiver support, as measured by PHQ-2

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    The PHQ-9 consists of 2 items, each of which is scored 0 to 3, giving a 0 to 6 severity score

  36. Change in caregiver support, as measured by PCL-5

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    The PCL-5 is a 20 item screen to assess symptoms of PTSD.

  37. Change in caregiver support, as measured by Ego Resiliency

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    14 item survey scored from 0-56, where a higher score indicates higher level of resiliency

  38. Change in caregiver support, as measured by PROMIS Depression

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  39. Change in caregiver support, as measured by PROMIS Anxiety

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  40. Change in caregiver support, as measured by PROMIS Emotional Support

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  41. Change in caregiver support, as measured by PROMIS Social Isolation

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    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.

  42. Change in microbiota diversity, as measured by skin swabs

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    Skin swab samples batch sequenced and microbiome analyzed

  43. Change in microbiota diversity, as measured by stool samples

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    Changes in stool samples as measured by 16s rRNA sequencing

  44. Change in biomarkers of inflammation and frailty, as measured by blood plasma samples

    Time frame: Baseline, Post-intervention (week 12), 1 Year

    Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty

  45. Overall survival, as measured by medical record review

    Time frame: 1 year

  46. Disease-free survival, as measured by medical record review

    Time frame: 1 year

  47. Rate of bacterial infection, as measured by medical record review

    Time frame: 1 year

  48. Rate of fungal infection, as measured by medical record review

    Time frame: 1 year

  49. Rate of viral infection, as measured by medical record review

    Time frame: 1 year

  50. Rate of overall infection, as measured by medical record review

    Time frame: 1 year

  51. Rate of hospital admission, as measured by medical record review

    Time frame: 1 year

  52. Rate of intensive care unit admission, as measured by medical record review

    Time frame: 1 year

  53. Hospital length of stay, as measured by medical record review

    Time frame: 1 year

  54. Intensive care unit length of stay, as measured by medical record review

    Time frame: 1 year

  55. Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review

    Time frame: 1 year

  56. Transplant length of stay (in days), as measured by medical record review

    Time frame: 1 year

  57. Number of patients who returned to work, as assessed by Work Assessment

    Time frame: 1 year

  58. Number of falls, as assessed by Falls questionnaire

    Time frame: 1 year

    Participants will answer Yes/No to whether they have had any falls in the preceding 6 months

  59. Number of subjects who experienced delirium, as assessed by DOS assessment

    Time frame: 1 year

    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.

  60. Change in quality of life, as assessed by FACT-BMT assessment

    Time frame: Baseline, Post-intervention (12 weeks), 1 Year

    50 item assessment. Higher total and domain scores indicate greater quality of life.

  61. Change in quality of life, as assessed by EQ-5D-5L assessment

    Time frame: Baseline, Post-intervention (12 weeks), 1 Year

    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.

  62. Change in quality of life, as assessed by OARS IADL assessment

    Time frame: Baseline, Post-intervention (12 weeks), 1 Year

    OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: S-POP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2022
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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