Clinical trial NCT04968119: Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant
Official title: A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation rate
timeFrame: Week 9
measure: Intervention completion rate
timeFrame: Week 9
Secondary outcomes:
measure: Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance
timeFrame: From baseline to week 9
measure: Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed
timeFrame: From baseline to week 9
measure: Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand
timeFrame: From baseline to week 9
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kyuwan Lee
role: PRINCIPAL_INVESTIGATOR
References: