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RIC (Remote Ischemic Conditioning) in Older Individuals

Not Applicable
Conditions
Old Age
Mobility Limitation
Debility
Interventions
Other: Low-intensity resistance exercise training
Other: 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
Inclusion Criteria
  • Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
RIC (Remote Ischemic Conditioning) InterventionRemote 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 InterventionLow-intensity resistance exercise trainingLow-intensity resistance exercise training only.
RIC (Remote Ischemic Conditioning) InterventionLow-intensity resistance exercise trainingLow-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
NameTimeMethod
Feasibility of study intervention as measured by the number of participants who completed the studyUp to 6 weeks
Feasibility of study intervention as measured by the attrition rateUp 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 participantUp to 6 weeks
Feasibility of study intervention as measured by the number of RIC home applications completed per participantUp to 6 weeks
Acceptability of study intervention as measured by an Intervention Acceptability QuestionnaireUp 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
NameTimeMethod
Change in muscle strength as measured by dynamometryBaseline 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 testingBaseline to post-intervention visit (approximately 7 weeks)
Change in vascular function as measured by arterial tonometryBaseline 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 collectionUp to 6 weeks
Change in Brief Resilience 5-point Likert ScaleBaseline to post-intervention visit (approximately 7 weeks)

Higher score indicates greater resilience.

Change in quality of life as measured by PROMIS-29Baseline to post-intervention visit (approximately 7 weeks)

Trial Locations

Locations (1)

Duke University

🇺🇸

Durham, North Carolina, United States

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