RIC (Remote Ischemic Conditioning) in Older Individuals

Not Applicable

• Conditions: Old Age; Mobility Limitation; Debility

• 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

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Status Verified: 2024-09
• Study Start: 2024-09-30
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-06
• Study Completion: 2026-07

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of study intervention as measured by the attrition rate	Up 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 participant	Up to 6 weeks
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 number of RIC home applications completed per participant	Up to 6 weeks
Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire	Up 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

Name	Time	Method
Feasibility of collecting blood samples during study as measured by the success rate of collection	Up to 6 weeks
Change in Brief Resilience 5-point Likert Scale	Baseline to post-intervention visit (approximately 7 weeks)	Higher score indicates greater resilience.
Change in muscle strength as measured by dynamometry	Baseline 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 testing	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)
Change in Short Physical Performance Battery (SPPB)	Baseline to post-intervention visit (approximately 7 weeks)	The SPPB measures changes in physical function.
Change in quality of life as measured by PROMIS-29	Baseline to post-intervention visit (approximately 7 weeks)

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States