Clinical trial NCT06476288: RIC (Remote Ischemic Conditioning) in Older Individuals
Official title: Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Old Age
Mobility Limitation
Debility
Keywords: Exercise
Strength training
Conditioning
RIC
Remote Ischemic Conditioning
Ischemic Conditioning
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of study intervention as measured by the number of participants who completed the study
timeFrame: Up to 6 weeks
measure: Feasibility of study intervention as measured by the attrition rate
timeFrame: Up to 6 weeks
measure: Feasibility of study intervention as measured by the number of exercise visits attended per participant
timeFrame: Up to 6 weeks
measure: Feasibility of study intervention as measured by the number of RIC home applications completed per participant
timeFrame: Up to 6 weeks
measure: Acceptability of study intervention as measured by an Intervention Acceptability Questionnaire
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Feasibility of collecting blood samples during study as measured by the success rate of collection
timeFrame: Up to 6 weeks
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
measure: Change in muscle strength as measured by dynamometry
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
measure: Change in exercise tolerance as measured by VO2peak testing
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
measure: Change in quality of life as measured by PROMIS-29
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
measure: Change in Brief Resilience 5-point Likert Scale
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
measure: Change in vascular function as measured by arterial tonometry
timeFrame: Baseline to post-intervention visit (approximately 7 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: W Todd Cade, PhD
role: PRINCIPAL_INVESTIGATOR
References: