Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant
NCT ID: NCT04968119
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2021-07-12
2024-10-08
Brief Summary
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The exercise program uses a telehealth platform (e.g. smart phones, tablets or computers) to view pre-recorded exercise videos on coordination, posture, stretching, balance and resistance/aerobic training.
Physical activity may help to improve physical function, including frailty, after bone marrow transplant. Information from this trial may help researchers design future telehealth exercise routines for treating people with cancer.
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Detailed Description
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I. Determine the feasibility of the telehealth exercise program, as evaluated by participation and completion rates.
SECONDARY OBJECTIVE:
I. Explore the effects of the telehealth exercise program on physical functioning.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).
ARM B: Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A (telehealth intervention)
Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).
Exercise Intervention
Participate in telehealth exercise sessions
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (delayed exercise intervention)
Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.
Exercise Intervention
Participate in telehealth exercise sessions
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Exercise Intervention
Participate in telehealth exercise sessions
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>= 2-years from hematopoietic cell transplantation (HCT) and in clinical remission
* Identified as pre-frail or frail based on Bone Marrow Transplant Survivorship Study (BMTSS) questionnaire (i.e. clinically underweight, exhaustion, low energy expenditure, slow walking speed, and muscle weakness), with the presence of \>= 3/5 indices classified as frail and 2/5 indices classified as prefrail
* Able to understand and sign the informed consent document
* Physically able and willing to complete all study procedures
* Has access to the internet and a smartphone
* English speaking
Exclusion Criteria
* Contraindications to exercise (acute infectious disease, physical disability preventing safe performance \[assistive devices\], cognitive impairment or inability to cooperate)
* Participation in regular exercise (\> 60 minutes per week)
* Female who are pregnant or planning to become pregnant
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kyuwan Lee
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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References
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Lee K, Shamunee J, Lindenfeld L, Ross E, Hageman L, Sedrak MS, Wong FL, Nakamura R, Forman SJ, Bhatia S, Armenian SH. Feasibility of implementing a supervised telehealth exercise intervention in frail survivors of hematopoietic cell transplantation: a pilot randomized trial. BMC Cancer. 2023 May 1;23(1):390. doi: 10.1186/s12885-023-10884-5.
Other Identifiers
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NCI-2021-03539
Identifier Type: REGISTRY
Identifier Source: secondary_id
20731
Identifier Type: OTHER
Identifier Source: secondary_id
20731
Identifier Type: -
Identifier Source: org_study_id
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