Hematologic MalignancyS-POPNCT05238376
Survivorship Post-HCT Optimization Program
A study testing Exercise training in people with Hematologic Malignancy, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 23 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Adult Blood and Marrow Transplant Clinic
Durham, North Carolina, 27705
About this study
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
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
- Being tested
- Exercise training
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
12 weeks of high intensity interval training (HIIT) (3x/week) and resistance training (2x/week)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to prescribed exercise program, as measured by number of total sessions completed
Measured: 12 weeks
Compliance to prescribed HIIT sessions, as measured by total session time (in minutes)
Measured: 12 weeks
Compliance to prescribed HIIT sessions, as measured by number of intervals completed
Measured: 12 weeks
Compliance to prescribed HIIT sessions, as measured by number/percentage of intervals meeting target heart rates
Measured: 12 weeks
Compliance to prescribed resistance sessions, as measured by number of sets completed
Measured: 12 weeks
Compliance to prescribed resistance sessions, as measured by number of repetitions completed
Measured: 12 weeks
Secondary outcomes (62)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-intervention (week 12), 1 Year
Change in microbiota diversity, as measured by skin swabs
Skin swab samples batch sequenced and microbiome analyzed
Measured: 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
Measured: 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
Measured: Baseline, Post-intervention (week 12), 1 Year
Overall survival, as measured by medical record review
Measured: 1 year
Disease-free survival, as measured by medical record review
Measured: 1 year
Rate of bacterial infection, as measured by medical record review
Measured: 1 year
Rate of fungal infection, as measured by medical record review
Measured: 1 year
Rate of viral infection, as measured by medical record review
Measured: 1 year
Rate of overall infection, as measured by medical record review
Measured: 1 year
Rate of hospital admission, as measured by medical record review
Measured: 1 year
Rate of intensive care unit admission, as measured by medical record review
Measured: 1 year
Hospital length of stay, as measured by medical record review
Measured: 1 year
Intensive care unit length of stay, as measured by medical record review
Measured: 1 year
Number of patients with grade 2+ graft-versus-host disease, as measured by medical record review
Measured: 1 year
Transplant length of stay (in days), as measured by medical record review
Measured: 1 year
Number of patients who returned to work, as assessed by Work Assessment
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Post-intervention (12 weeks), 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start2 Dec 2022
- Primary completion26 Feb 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chenyu Lin, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238376
- Sponsor's protocol ID
- Pro00110028
- Acronym
- S-POP
- Status last verified
- Sep 2025
- First submitted
- 2 Feb 2022
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05238376
- Acronym / sponsor ID
- S-POP / Pro00110028
- Conditions
- Hematologic Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Behavioral: Exercise trainingThese 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. |
| Caregiver | Experimental | Behavioral: Exercise trainingThese 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training12 weeks of high intensity interval training (HIIT) (3x/week) and resistance training (2x/week) | Behavioural | Caregiver, Patient |
Primary outcome
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
62 secondary outcomes
Change in physical function/activity, as measured by SPPB
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by 6-minute walk test
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by 30-second sit-to-stand
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by grip strength
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Fried Frailty
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by PROMIS Physical Function
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by bioelectrical impedance (BIA)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by CPET
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Intramuscular Adipose Tissue (IMAT)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by Intramuscular Glycogen Content (IMGC)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by muscle thickness
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by muscle area
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in physical function/activity, as measured by subcutaneous fat layer thickness
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Montreal Cognitive Assessment (MOCA)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by PROMIS Cognitive Function
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by RBANS
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Trail making test
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in cognitive function, as measured by Brief Cope
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PHQ-9
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PC-PTSD/PCL-5
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PROMIS Depression
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in mental health, as measured by PROMIS Anxiety
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by Perioperative Nutrition Screen (PONS)
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by PG-SGA/Clinician SGA
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by ASA-24
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in diet/nutrition, as measured by Food Security
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by PROMIS Emotional Support
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by PROMIS Social Isolation
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by Lorig Self Efficacy
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by CFC-14
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in social support, as measured by Brief Resilience Scale
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Caregiver Strain index
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Preparedness for Caregiving assessment
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by FACT-GP
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PHQ-2
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PCL-5
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by Ego Resiliency
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Depression
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Anxiety
Time frame: Baseline, Post-intervention (week 12), 1 Year
Change in caregiver support, as measured by PROMIS Emotional Support
Time frame: Baseline, Post-intervention (week 12), 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingPhase 3
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Multiple Myeloma
RecruitingObservational study
Menin Inhibitors in Pediatric Relapsed or Refractory Acute Leukemia
Acute Leukemia, Relapsed or Refractory Pediatric Leukemia
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenyu Lin, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Hematologic Malignancy, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to prescribed exercise program, as measured by number of total sessions completed (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.