RIC (Remote Ischemic Conditioning) in Older Individuals

NCT06476288 | Enrolling By Invitation DMC

• 1 other identifier: Pro00115014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age; Mobility Limitation; Debility

Keywords

Exercise; Strength training; Conditioning; RIC; Remote Ischemic Conditioning; Ischemic Conditioning

Outcome Measures

Primary Outcomes (5)

• 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

  Attrition rate is expressed as a percentage and is calculated by dividing the number of non-completers by the total number of participants.

  Up to 6 weeks

• 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

  Each participant will complete an Intervention Acceptability Questionnaire with responses on a 5-point Likert scale, where a higher score indicates greater acceptability.

  Up to 6 weeks

Secondary Outcomes (7)

• Feasibility of collecting blood samples during study as measured by the success rate of collection

  Up to 6 weeks

• Change in Short Physical Performance Battery (SPPB)

  Baseline to post-intervention visit (approximately 7 weeks)

• Change in muscle strength as measured by dynamometry

  Baseline to post-intervention visit (approximately 7 weeks)

• Change in exercise tolerance as measured by VO2peak testing

  Baseline to post-intervention visit (approximately 7 weeks)

• Change in quality of life as measured by PROMIS-29

  Baseline to post-intervention visit (approximately 7 weeks)

Study Arms (2)

High-Dose RIC (Remote Ischemic Conditioning) Intervention

ACTIVE COMPARATOR

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

Other: Low-intensity resistance exercise training; Other: High-Dose Remote ischemic conditioning (RIC)

Low-Dose RIC Intervention

PLACEBO COMPARATOR

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

Other: Low-intensity resistance exercise training; Other: Low-Dose Remote ischemic conditioning (RIC)

Interventions

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.

High-Dose RIC (Remote Ischemic Conditioning) Intervention

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.

Low-Dose RIC Intervention

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 RIC (Remote Ischemic Conditioning) Intervention; Low-Dose RIC Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Mobility Limitation; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Study Officials

• W Todd Cade, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)