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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose RIC (Remote Ischemic Conditioning) Intervention | Active Comparator | Low-intensity resistance exercise training plus high-dose RIC. |
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| Low-Dose RIC Intervention | Placebo Comparator | Low-intensity resistance exercise training plus low-dose RIC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | Up to 6 weeks |
| 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 RIC home applications completed per participant | 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. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of collecting blood samples during study as measured by the success rate of collection | Up to 6 weeks | |
| Change in Short Physical Performance Battery (SPPB) | The SPPB measures changes in physical function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W Todd Cade, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D000073496 | Frailty |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D001519 | Behavior |
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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.
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| 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. |
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| 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. |
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| 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. | Baseline to post-intervention visit (approximately 7 weeks) |
| Change in exercise tolerance as measured by VO2peak testing | Baseline to post-intervention visit (approximately 7 weeks) |
| Change in quality of life as measured by PROMIS-29 | Baseline to post-intervention visit (approximately 7 weeks) |
| Change in Brief Resilience 5-point Likert Scale | Higher score indicates greater resilience. | 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) |