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Enrolling by Invitation

NCT Number: NCT06476288

RIC (Remote Ischemic Conditioning) 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.

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Key information

Conditions

Old Age Behavior Debility Frailty Mobility Limitation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of study intervention as measured by the number of participants who completed the study

    Time frame: Up to 6 weeks

  2. Feasibility of study intervention as measured by the attrition rate

    Time frame: 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.

  3. Feasibility of study intervention as measured by the number of exercise visits attended per participant

    Time frame: Up to 6 weeks

  4. Feasibility of study intervention as measured by the number of RIC home applications completed per participant

    Time frame: Up to 6 weeks

  5. Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire

    Time frame: 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 outcomes

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

    Time frame: Up to 6 weeks

  2. Change in Short Physical Performance Battery (SPPB)

    Time frame: Baseline to post-intervention visit (approximately 7 weeks)

    The SPPB measures changes in physical function.

  3. Change in muscle strength as measured by dynamometry

    Time frame: 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.

  4. Change in exercise tolerance as measured by VO2peak testing

    Time frame: Baseline to post-intervention visit (approximately 7 weeks)

  5. Change in quality of life as measured by PROMIS-29

    Time frame: Baseline to post-intervention visit (approximately 7 weeks)

  6. Change in Brief Resilience 5-point Likert Scale

    Time frame: Baseline to post-intervention visit (approximately 7 weeks)

    Higher score indicates greater resilience.

  7. Change in vascular function as measured by arterial tonometry

    Time frame: Baseline to post-intervention visit (approximately 7 weeks)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 26, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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