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RIC (Remote Ischemic Conditioning) in Older Individuals

NCT ID: NCT06476288

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Old Age Mobility Limitation Debility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be split into two different groups: one receiving a high-dose RIC intervention with low-intensity exercise and the other receiving a low-dose RIC intervention with low-intensity exercise. The assignment to the two different groups will be done by a computer in a process similar to flipping a coin in a 1:1 ratio. There will be 10 participants in each group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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High-Dose RIC (Remote Ischemic Conditioning) Intervention

Low-intensity resistance exercise training plus high-dose RIC.

Group Type ACTIVE_COMPARATOR

Low-intensity resistance exercise training

Intervention Type 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)

Intervention Type 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 RIC Intervention

Low-intensity resistance exercise training plus low-dose RIC.

Group Type PLACEBO_COMPARATOR

Low-intensity resistance exercise training

Intervention Type OTHER

The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.

Low-Dose Remote ischemic conditioning (RIC)

Intervention Type 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.

Interventions

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Low-intensity resistance exercise training

The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.

Intervention Type OTHER

High-Dose Remote ischemic conditioning (RIC)

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.

Intervention Type OTHER

Low-Dose Remote ischemic conditioning (RIC)

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
2. Exercises ≤ 2x/week on a regular interval

Exclusion Criteria

1. Unstable heart disease as determined by the investigator or study physician
2. History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing/training as determined by the investigator
3. Cognitive inability to follow directions and safely participate in exercise
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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W Todd Cade, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00115014

Identifier Type: -

Identifier Source: org_study_id