Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant

Study Overview
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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.

Official Title
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A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
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* Other: Exercise Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (telehealth intervention)<br>Patients participate in telehealth exercise sessions at home over 30 minutes with a trainer 3 days a week for 8 weeks (24 total sessions). | Other: Exercise Intervention<br>* Participate in telehealth exercise sessions<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm B (delayed exercise intervention)<br>Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I. | Other: Exercise Intervention<br>* Participate in telehealth exercise sessions<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | Rate of participation is defined as number of hematopoietic cell transplantation (HCT) survivors who were approached and participated divided by the total number of eligible HCT survivors who were approached for the study and then multiplied by 100%. Will be considered feasible if >= 50% of eligible patients that are approached for participation enroll onto the study. Minimal descriptive statistical analyses will be performed for all participant baseline characteristics and compared across groups to test for balance across the groups, using t-tests (or non-parametric Wilcoxon rank sum) for continuous variables and chi-square tests for categorical variables. | Week 9 | 
| Intervention completion rate | Will be considered feasible if >= 75% of enrolled participants successfully complete all study measurements (remote physical function) and > 50% of patients randomized to the intervention arm are able to complete > 70% of total exercise sessions (17/24 sessions). Minimal descriptive statistical analyses will be performed for all participant baseline characteristics and compared across groups to test for balance across the groups, using t-tests (or non-parametric Wilcoxon rank sum) for continuous variables and chi square tests for categorical variables. | Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance | Physical functioning (Timed balance) will be measured in the unit of time as seconds. | From baseline to week 9 | 
| Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed | Physical functioning (Gait speed ) will be measured in the unit of time as seconds. | From baseline to week 9 | 
| Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand | Physical functioning (Chair stand ) will be measured in the unit of time as seconds. | From baseline to week 9 |