Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Feasibility of study intervention as measured by the attrition rate
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
- •Exercises ≤ 2x/week on a regular interval
排除标准
- •Unstable heart disease as determined by the investigator or study physician
- •History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing/training as determined by the investigator
- •Cognitive inability to follow directions and safely participate in exercise
研究组 & 干预措施
High-Dose RIC (Remote Ischemic Conditioning) Intervention
Low-intensity resistance exercise training plus high-dose RIC.
干预措施: Low-intensity resistance exercise training (Other)
High-Dose RIC (Remote Ischemic Conditioning) Intervention
Low-intensity resistance exercise training plus high-dose RIC.
干预措施: High-Dose Remote ischemic conditioning (RIC) (Other)
Low-Dose RIC Intervention
Low-intensity resistance exercise training plus low-dose RIC.
干预措施: Low-intensity resistance exercise training (Other)
Low-Dose RIC Intervention
Low-intensity resistance exercise training plus low-dose RIC.
干预措施: Low-Dose Remote ischemic conditioning (RIC) (Other)
结局指标
主要结局
Feasibility of study intervention as measured by the attrition rate
时间窗: Up to 6 weeks
Attrition rate is expressed as a percentage and is calculated by dividing the number of non-completers by the total number of participants.
Feasibility of study intervention as measured by the number of exercise visits attended per participant
时间窗: Up to 6 weeks
Feasibility of study intervention as measured by the number of participants who completed the study
时间窗: Up to 6 weeks
Feasibility of study intervention as measured by the number of RIC home applications completed per participant
时间窗: Up to 6 weeks
Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire
时间窗: Up to 6 weeks
Each participant will complete an Intervention Acceptability Questionnaire with responses on a 5-point Likert scale, where a higher score indicates greater acceptability.
次要结局
- Change in muscle strength as measured by dynamometry(Baseline to post-intervention visit (approximately 7 weeks))
- Change in exercise tolerance as measured by VO2peak testing(Baseline to post-intervention visit (approximately 7 weeks))
- Change in vascular function as measured by arterial tonometry(Baseline to post-intervention visit (approximately 7 weeks))
- Change in quality of life as measured by PROMIS-29(Baseline to post-intervention visit (approximately 7 weeks))
- Change in Short Physical Performance Battery (SPPB)(Baseline to post-intervention visit (approximately 7 weeks))
- Feasibility of collecting blood samples during study as measured by the success rate of collection(Up to 6 weeks)
- Change in Brief Resilience 5-point Likert Scale(Baseline to post-intervention visit (approximately 7 weeks))