Old AgeNCT06476288
RIC (Remote Ischemic Conditioning) in Older Individuals
A study testing Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC) and Low-Dose Remote ischemic conditioning (RIC) in people with Old Age and Mobility Limitation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age, Mobility Limitation, Debility
- What is being tested?
- Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC) and Low-Dose Remote ischemic conditioning (RIC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
- Exercises ≤ 2x/week on a regular interval
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Old Age, Mobility Limitation, Debility
- Being tested
- Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC), Low-Dose Remote ischemic conditioning (RIC)
- Keywords
- Exercise, Strength training, Conditioning, RIC, Remote Ischemic Conditioning, Ischemic Conditioning
- Medical subject headings
- Mobility Limitation, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity resistance exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose RIC (Remote Ischemic Conditioning) Intervention | Active comparator | Low-intensity resistance exercise training plus high-dose RIC. Receives: Other: Low-intensity resistance exercise training; Other: High-Dose Remote ischemic conditioning (RIC) |
| Low-Dose RIC Intervention | Placebo comparator | Low-intensity resistance exercise training plus low-dose RIC. Receives: Other: Low-intensity resistance exercise training; Other: Low-Dose Remote ischemic conditioning (RIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study intervention as measured by the number of participants who completed the study
Measured: 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.
Measured: Up to 6 weeks
Feasibility of study intervention as measured by the number of exercise visits attended per participant
Measured: Up to 6 weeks
Feasibility of study intervention as measured by the number of RIC home applications completed per participant
Measured: 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.
Measured: Up to 6 weeks
Secondary outcomes (7)
Feasibility of collecting blood samples during study as measured by the success rate of collection
Measured: Up to 6 weeks
Change in Short Physical Performance Battery (SPPB)
The SPPB measures changes in physical function.
Measured: 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.
Measured: Baseline to post-intervention visit (approximately 7 weeks)
Change in exercise tolerance as measured by VO2peak testing
Measured: Baseline to post-intervention visit (approximately 7 weeks)
Change in quality of life as measured by PROMIS-29
Measured: Baseline to post-intervention visit (approximately 7 weeks)
Change in Brief Resilience 5-point Likert Scale
Higher score indicates greater resilience.
Measured: Baseline to post-intervention visit (approximately 7 weeks)
Change in vascular function as measured by arterial tonometry
Measured: Baseline to post-intervention visit (approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start30 Sep 2024
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- W Todd Cade, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476288
- Sponsor's protocol ID
- Pro00115014
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Remote Ischemic Conditioning to Achieve High-Intensity Rehabilitation Effects and Increase Resilience in Older Individuals
- ClinicalTrials.gov ID
- NCT06476288
- Acronym / sponsor ID
- Pro00115014
- Conditions
- Old Age, Mobility Limitation, Debility
- Keywords
- Exercise, Strength training, Conditioning, RIC, Remote Ischemic Conditioning, Ischemic Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-Dose RIC (Remote Ischemic Conditioning) Intervention | Active comparator | Other: Low-intensity resistance exercise training, Other: High-Dose Remote ischemic conditioning (RIC)Low-intensity resistance exercise training plus high-dose RIC. |
| Low-Dose RIC Intervention | Placebo comparator | Other: Low-intensity resistance exercise training, Other: Low-Dose Remote ischemic conditioning (RIC)Low-intensity resistance exercise training plus low-dose RIC. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk
- Exercises ≤ 2x/week on a regular interval
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity resistance exercise trainingThe intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks. | Other | High-Dose RIC (Remote Ischemic Conditioning) Intervention, Low-Dose RIC Intervention |
| 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 | High-Dose RIC (Remote Ischemic Conditioning) Intervention |
| 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. | Other | Low-Dose RIC Intervention |
Primary outcome
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
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
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
Each participant will complete an Intervention Acceptability Questionnaire with responses on a 5-point Likert scale, where a higher score indicates greater acceptability.
7 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W Todd Cade, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity resistance exercise training, High-Dose Remote ischemic conditioning (RIC) and Low-Dose Remote ischemic conditioning (RIC) in people with Old Age and Mobility Limitation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study intervention as measured by the number of participants who completed the study (time frame: Up to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.