RIC (Remote Ischemic Conditioning) in Older Individuals

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06476288
Status
Enrolling By Invitation

Conditions

  • Debility
  • Mobility Limitation
  • Old Age

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-intensity resistance exercise training — OTHER
    The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.
  • High-Dose Remote ischemic conditioning (RIC) — OTHER
    Treatment dose of RIC- the RIC cuff will be inflated to 20 mmHg over the participant's systolic blood pressure. The treatment dose of RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.
  • Low-Dose Remote ischemic conditioning (RIC) — OTHER
    This dose will be the control for the study. Low-dose RIC- the RIC cuff will be inflated to 10 mmHg below the participant's diastolic blood pressure. The low-dose RIC will be applied in 4 sets of cycles with inflating the cuff and leaving it pumped for 5 minutes then deflating the cuff for an off period of 5 minutes. Total treatment time will be 35 minutes.

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: High-Dose RIC (Remote Ischemic Conditioning) Intervention
    Low-intensity resistance exercise training plus high-dose RIC.
  • Placebo Comparator: Low-Dose RIC Intervention
    Low-intensity resistance exercise training plus low-dose RIC.

Primary Outcome Measure

Feasibility of study intervention as measured by the number of participants who completed the study [ Time Frame: Up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

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By research site
Duke University· Durham, NC

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