Telehealth Exercise Platform to Reduce Frailty After Bone Marrow Transplant
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Interventions
- Other: Exercise InterventionOther: Quality-of-Life AssessmentOther: Questionnaire Administration
- Registration Number
- NCT04968119
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- >= 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (telehealth intervention) Exercise 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). Arm A (telehealth intervention) Quality-of-Life Assessment 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 A (telehealth intervention) Questionnaire Administration 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 (delayed exercise intervention) 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. Arm B (delayed exercise intervention) Quality-of-Life Assessment Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I. Arm B (delayed exercise intervention) Questionnaire Administration Patients maintain their normal activities of daily living for 8 weeks before participating in the telehealth exercise program as described in Arm I.
- Primary Outcome Measures
Name Time Method Intervention completion rate Week 9 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.Participation rate Week 9 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.
- Secondary Outcome Measures
Name Time Method Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand From baseline to week 9 Physical functioning (Chair stand ) will be measured in the unit of time as seconds.
Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed From baseline to week 9 Physical functioning (Gait speed ) will be measured in the unit of time as seconds.
Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance From baseline to week 9 Physical functioning (Timed balance) will be measured in the unit of time as seconds.
Trial Locations
- Locations (1)
City of Hope Medical Center
🇺🇸Duarte, California, United States