Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

NCT ID: NCT04968119

Last Updated: 2025-02-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2024-10-08

Brief Summary

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This clinical trial studies the feasibility of implementing a telehealth exercise platform to reduce frailty in patients after bone marrow transplant.

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.

Detailed Description

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PRIMARY OBJECTIVE:

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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Hematopoietic and Lymphoid Cell Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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).

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type OTHER

Participate in telehealth exercise sessions

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Exercise Intervention

Intervention Type OTHER

Participate in telehealth exercise sessions

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Intervention

Participate in telehealth exercise sessions

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* \>= 18 years of age at the time of study enrollment
* \>= 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

* Overt cardiovascular disease (e.g. myocardial infarction, stroke, angina)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 37127595 (View on PubMed)

Other Identifiers

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NCI-2021-03539

Identifier Type: REGISTRY

Identifier Source: secondary_id

20731

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20731

Identifier Type: -

Identifier Source: org_study_id

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