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Enrolling by invitation NCT06476288

RIC (Remote Ischemic Conditioning) in Older Individuals

No phase Interventional Old Age Mobility Limitation Debility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC), Low-Dose Remote ischemic conditioning (RIC).
Who it may be relevant to
Registry conditions: Old Age, Mobility Limitation, Debility. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Feasibility of study intervention as measured by the number of participants who completed the study [Time frame: Up to 6 weeks]
  • Feasibility of study intervention as measured by the attrition rate [Time frame: Up to 6 weeks]
  • Feasibility of study intervention as measured by the number of exercise visits attended per participant [Time frame: Up to 6 weeks]
  • Feasibility of study intervention as measured by the number of RIC home applications completed per participant [Time frame: Up to 6 weeks]
  • Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire [Time frame: Up to 6 weeks]
Secondary outcome measures (7)
  • Feasibility of collecting blood samples during study as measured by the success rate of collection [Time frame: Up to 6 weeks]
  • Change in Short Physical Performance Battery (SPPB) [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in muscle strength as measured by dynamometry [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in exercise tolerance as measured by VO2peak testing [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in quality of life as measured by PROMIS-29 [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in Brief Resilience 5-point Likert Scale [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]
  • Change in vascular function as measured by arterial tonometry [Time frame: Baseline to post-intervention visit (approximately 7 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT06476288 · Pro00115014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗