Impact of Exercise on the Complications of Corticosteroids in Patients With Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplantation: the RESTART Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Proportion of patients completing the exercise intervention sessions
研究概览
简要总结
This study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant.
The names of the study interventions involved in this study are:
- Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program
- Attention control (AC) - Home-based stretching program
详细描述
This research study is a feasibility study, which is the first-time investigators are examining an aerobic and resistance exercise (A+R) in patients diagnosed with acute or chronic GVHD after having an allogeneic stem cell transplant and if participating in a specific exercise program can improve glycemic control, body composition, physical fitness and function, and patient-reported outcomes.
This study consists of participants randomly assigned in 2(A+R):1(AC) ratio to one of two groups:
- Aerobic and resistance exercise (A+R), or
- Attention control (AC)
The A+R group will be asked to perform aerobic exercise, which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting), to help build muscle mass and strength. The AC group will be asked to perform stretching only and not to change their activity behavior.
All participants will also undergo four testing visits involving four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
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
- •Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
- •Newly diagnosed with acute or chronic GVHD, starting corticosteroids at a dose of .20 mg/kg or greater for the first time since transplant
- •Received allogeneic stem cell transplant (any conditioning, any donor) at Dana-Farber Cancer Institute
- •Physician's clearance to participate in moderate-vigorous intensity exercise
- •Speak English
- •Currently participate in less than 60 minutes of structured exercise/week
- •Willing to travel to Dana-Farber Cancer Institute for necessary data collection
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Have a plan for hospital admission within the next 13 weeks at the time of recruitment
- •If patients are not enrolled within 14 days after initial steroid treatment, they will be ineligible
- •Pre-existing musculoskeletal or cardiorespiratory conditions
- •Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
- •Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- •Patients with other active malignancies
- •Participate in more than 60 minutes of structured exercise/week
- •Unable to travel to Dana-Farber Cancer Institute for necessary data collection
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
Exercise Group
Home-based, virtually supervised via Zoom, 3x weekly for 12-weeks aerobic and resistance exercise program
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
干预措施: Exercise (Behavioral)
Attention control Group
Home-based, 12-week stretching program only with participants asked not to change their activity behavior.
Participants will also undergo four testing visits across 6-month period. Tests will include four blood draws and three body composition scans via a dual-energy x-ray absorptiometry (DXA).
干预措施: Attention control (Behavioral)
结局指标
主要结局
Proportion of patients completing the exercise intervention sessions
时间窗: 12 weeks
The primary outcome is feasibility and will be assessed by the proportion of patients completing the exercise intervention sessions with \>70% completion considered feasible.
次要结局
- Physical Function - Handgrip Strength(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Physical Function - Timed Up and Go(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Patient reported outcomes - Quality of Life(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Physical function - Margaria Stair Climb(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Body Composition(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Physical Fitness(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Patient reported outcomes - Sleep(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Patient reported outcomes - Fatigue(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Glycemic control level(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Cardiopulmonary Fitness(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Muscular Strength(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Patient reported outcomes - Function(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Physical Function - 6 minute walk test(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
- Patient reported outcomes - Anxiety and Depression(Evaluated at week 1 at baseline and week 7 on treatment, and at week 13 post-treatment also at week 25 follow-up)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute