RIC (Remote Ischemic Conditioning) in Older Individuals

Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mobility Limitation; Old Age; Debility
• Intervention / Treatment: Other: Low-intensity resistance exercise training; Other: High-Dose Remote ischemic conditioning (RIC); Other: Low-Dose Remote ischemic conditioning (RIC)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High-Dose RIC (Remote Ischemic Conditioning) Intervention; Low-intensity resistance exercise training plus high-dose RIC.	Other: Low-intensity resistance exercise training; The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.; 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.
Placebo Comparator: Low-Dose RIC Intervention; Low-intensity resistance exercise training plus low-dose RIC.	Other: Low-intensity resistance exercise training; The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The SPPB measures changes in physical function.	Baseline to post-intervention visit (approximately 7 weeks)
Change in muscle strength as measured by dynamometry	Measurements made with isokinetic dynamometry, hand-held dynamometry and DXA scans completed at pre- and post-intervention.	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)
Change in Brief Resilience 5-point Likert Scale	Higher score indicates greater resilience.	Baseline to post-intervention visit (approximately 7 weeks)
Change in vascular function as measured by arterial tonometry		Baseline to post-intervention visit (approximately 7 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: W Todd Cade, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Remote Ischemic Conditioning; Strength training; Conditioning; Ischemic Conditioning; RIC
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Frailty; Mobility Limitation; Motor Activity
• Other Study ID Numbers: Pro00115014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No