RIC (Remote Ischemic Conditioning) in Older Individuals
- Conditions
- Old AgeMobility LimitationDebility
- Interventions
- Other: Low-intensity resistance exercise trainingOther: Remote ischemic conditioning (RIC)
- Registration Number
- NCT06476288
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RIC (Remote Ischemic Conditioning) Intervention Remote ischemic conditioning (RIC) Low-intensity resistance exercise training plus RIC. RIC will be applied to the upper arm and then inflated and deflated in cycles. The cycles are 5 minutes long. There are 4 sets of cycles of intervention with inflation of the cuff (5 minutes ON) and deflation of the cuff (5 minutes OFF) for 35 minutes total. The amount of inflation will be pre-determined. This intervention will be completed 5 times per week. Sham RIC Intervention Low-intensity resistance exercise training Low-intensity resistance exercise training only. RIC (Remote Ischemic Conditioning) Intervention Low-intensity resistance exercise training Low-intensity resistance exercise training plus RIC. RIC will be applied to the upper arm and then inflated and deflated in cycles. The cycles are 5 minutes long. There are 4 sets of cycles of intervention with inflation of the cuff (5 minutes ON) and deflation of the cuff (5 minutes OFF) for 35 minutes total. The amount of inflation will be pre-determined. This intervention will be completed 5 times per week.
- Primary Outcome Measures
Name Time Method Feasibility of study intervention as measured by the number of participants who completed the study Up to 6 weeks Feasibility of study intervention as measured by the attrition rate 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 Up to 6 weeks Feasibility of study intervention as measured by the number of RIC home applications completed per participant Up to 6 weeks Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire 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.
- Secondary Outcome Measures
Name Time Method Change in muscle strength as measured by dynamometry Baseline to post-intervention visit (approximately 7 weeks) Measurements made with isokinetic dynamometry, hand-held dynamometry and DXA scans completed at pre- and post-intervention.
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 Short Physical Performance Battery (SPPB) Baseline to post-intervention visit (approximately 7 weeks) The SPPB measures changes in physical function.
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) Higher score indicates greater resilience.
Change in quality of life as measured by PROMIS-29 Baseline to post-intervention visit (approximately 7 weeks)
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States