Exercise training for Blood Cancers

Duke Adult Blood and Marrow Transplant Clinic, Durham, NC
Blood CancersExercise training - Behavioral
Eligibility
18 - 80
All Sexes

Study Summary

This trial will investigate the effects of high-intensity interval training and resistance training on physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant, as well as in the caregivers of these patients.

Eligible Conditions
  • Blood Cancers

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

6 Primary · 62 Secondary · Reporting Duration: Baseline, Post-intervention (week 12), 1 Year

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

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Patient
1 of 2
Caregiver
1 of 2

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Exercise training · No Placebo Group · N/A

Patient
Behavioral
Experimental Group · 1 Intervention: Exercise training · Intervention Types: Behavioral
Caregiver
Behavioral
Experimental Group · 1 Intervention: Exercise training · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 1
~1130

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, post-intervention (week 12), 1 year

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,239 Previous Clinical Trials
3,040,665 Total Patients Enrolled
Anthony Sung, MDPrincipal InvestigatorDuke University
9 Previous Clinical Trials
632 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years old.
You must be able to speak English.
You have had an allogenic hematopoietic cell transplantation (HCT) within the past 90-120 days.
You need to have a plan for taking care of yourself after leaving the hospital following a hematopoietic stem cell transplant.
I'm sorry, it seems like you did not complete the criteria. Could you please provide me with more information?
References

Frequently Asked Questions

Is there currently an opportunity for participants to join this investigation?

"Affirmative. Based on the information housed by clinicaltrials.gov, this study is actively recruiting participants and was last modified on October 5th 2022. 70 people need to be recruited from 1 medical site for full participation in the trial." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial accept patients of age 25 and up?

"According to the requirements for entry, participants must be aged between 18 and 80 in order to take part." - Anonymous Online Contributor

Unverified Answer

Are the criteria for enrolment in this trial compatible with my qualifications?

"The trial is accepting 70 adults (aged 18 to 80) with hematologic neoplasms. To be eligible, participants must meet the following conditions: speaking English fluently; having undergone allogenic HCT within 90 ± 30 days prior to enrollment; providing post-discharge care for a patient who has received HCT and being both a patient and caregiver." - Anonymous Online Contributor

Unverified Answer

How many participants are involved in the current experiment?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical investigation is recruiting volunteers as of now, having been initially advertised on November 1st 2022 and edited most recently on October 5th 2022. The study requires 70 participants to be sourced from 1 centre." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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