A Novel Telehealth Exercise Platform to Reduce Frailty in Hematopoietic Cell Transplantation Survivors: A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Intervention completion rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 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
排除标准
- •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
结局指标
主要结局
Intervention completion rate
时间窗: 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
时间窗: 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.
次要结局
- Changes in the efficacy of the telehealth exercise program on physical functioning - Chair stand(From baseline to week 9)
- Changes in the efficacy of the telehealth exercise program on physical functioning - Gait speed(From baseline to week 9)
- Changes in the efficacy of the telehealth exercise program on physical functioning - Timed balance(From baseline to week 9)