Home-based Exercise to Improve Functional Outcomes in Veterans With Recently Healed Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Gait speed
研究概览
简要总结
Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility.
People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical.
This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.
详细描述
Population: 25 Veterans with a healed foot ulcer in the last 3-15 months
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 2 years
Study Design: Randomized, outcome assessor blinded, clinical trial comparing a) a 12-week home-based exercise regimen to b) standard of care
Objectives:
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 其他
- 盲法
- 单盲 (结局评估者)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Adults >= 50 years
- Diagnosis of diabetes
- Prior plantar foot ulcer or moderate-severe diabetic foot infection or minor lower extremity amputation.
- Two feet (can have healed minor amputations of fore and midfoot)
- Willing to wear appropriately fitted footwear for exercise regimen
- Ambulatory without walker
- Willing to enroll in the PODIMETRICS SmartMat program
- Able to give written informed consent
排除标准
- Unable to perform the exercise interventions (e.g. due to hearing or visual impairment)
- Anticipated foot surgery in the next 4 months
- Participating in another exercise program
- Current plantar foot ulcer or pre-ulcer
- Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate safely
研究组 & 干预措施
12-week standard of care
Participants in this group will be provided with guidance on the current standard of care. This includes guidance that these patients should slowly increase ambulation with appropriately fitted footwear.
干预措施: 12-week standard of care (Behavioral)
12-week home based exercise
Consistent with current physical activity recommendations for older adults, participants randomized in this arm will be prescribed 5 days/week of exercise, with seated cycling exercise performed on 3 days a week (Monday, Wednesday and Friday), and strength/balance exercise performed 2 days a week (Tuesday and Thursday).
干预措施: 12-week home based exercise (Behavioral)
结局指标
主要结局
Gait speed
时间窗: 12-weeks
Usual gait speed will be calculated based on a 10-meter walk distance. The investigators will provide individuals with a 14-meter path for walking to provide room for a "flying start." The participant will walk 14 meters, but gait speed will only be timed during the intermediate 10 meters. This will allow us to determine gait speed without the confounding factor of acceleration and deceleration.
次要结局
- Muscular strength(12-weeks)
- Perfusion(12-weeks)
- Feasibility- Recruitment(12-weeks)
- Glycemic control(12-weeks)
- Physical Activity(12-weeks)
- Acceptability- Usage Rating Profile-Intervention(12-weeks)
- Feasibility- Retention(12-weeks)
- Mobility(12-weeks)
- Acceptability(12-weeks)
- Adherence to the exercise regimen(12-weeks)
- Community mobility(12-weeks)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06312579
- 其他研究编号
- E4897-P
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (3个月前)
- 研究完成日期
- (6个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A limited dataset will be created and shared pursuant to a Data Use Agreement. Final data sets will be maintained locally until enterprise-level resources become available. Upon request, we will provide an electronic limited dataset to others in the scientific community with the implementation of appropriate data use agreements.