Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

City of Hope

Status: Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Treatments: Other: Exercise Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04968119

P30CA033572 (U.S. NIH Grant/Contract)

20731 (Other Identifier)

NCI-2021-03539 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Arm A (telehealth intervention)

Experimental group

Description:

Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions).

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Exercise Intervention

Arm B (delayed exercise intervention)

Active Comparator group

Description:

Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Exercise Intervention