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RIC (Remote Ischemic Conditioning) Intervention for Limited Mobility
N/A
Waitlist Available
Led By W Todd Cade, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to post-intervention visit (approximately 7 weeks)
Awards & highlights
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.
Who is the study for?
This trial is for people over 65 who have trouble moving around, possibly due to aging, weakness, or frailty. Participants should be able to perform some low-intensity exercises and must not have conditions that would make the trial unsafe or unsuitable for them.
What is being tested?
The study is testing whether adding remote ischemic conditioning (RIC) to low-intensity resistance exercise can improve muscle strength, mass, exercise tolerance, resilience, quality of life and physical function in older adults with limited mobility.
What are the potential side effects?
While specific side effects are not detailed here, RIC generally involves brief and repeated interruptions of blood flow which might cause discomfort. Exercise may lead to muscle soreness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to post-intervention visit (approximately 7 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to post-intervention visit (approximately 7 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire
Feasibility of study intervention as measured by the attrition rate
Feasibility of study intervention as measured by the number of RIC home applications completed per participant
+2 moreSecondary study objectives
Change in Brief Resilience 5-point Likert Scale
Change in Short Physical Performance Battery (SPPB)
Change in exercise tolerance as measured by VO2peak testing
+4 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: RIC (Remote Ischemic Conditioning) InterventionActive Control2 Interventions
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.
Group II: Sham RIC InterventionPlacebo Group1 Intervention
Low-intensity resistance exercise training only.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,764 Previous Clinical Trials
8,132,384 Total Patients Enrolled
Duke UniversityLead Sponsor
2,422 Previous Clinical Trials
3,066,485 Total Patients Enrolled
W Todd Cade, PhDPrincipal InvestigatorDuke University
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