Debility, Mobility Limitation, Old Age
Conditions
Keywords
Exercise, Strength training, Conditioning, RIC, Remote Ischemic Conditioning, Ischemic Conditioning
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.
Interventions
OTHERLow-intensity resistance exercise training
The intervention protocol will consist of 60 minutes of low-intensity resistance exercise training 3x/week for 6 weeks.
OTHERHigh-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.
OTHERLow-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.
Sponsors
Duke University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥ 65 years and referred to an exercise program for functional decline, deconditioning, or fall risk 2. Exercises ≤ 2x/week on a regular interval
Exclusion criteria
1. Unstable heart disease as determined by the investigator or study physician 2. History of any orthopaedic, neurologic, or metabolic condition that would contraindicate exercise testing/training as determined by the investigator 3. Cognitive inability to follow directions and safely participate in exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline to post-intervention visit (approximately 7 weeks) | The SPPB measures changes in physical function. |
| Change in muscle strength as measured by dynamometry | 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. |
| 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 | Baseline to post-intervention visit (approximately 7 weeks) | Higher score indicates greater resilience. |
| Change in vascular function as measured by arterial tonometry | Baseline to post-intervention visit (approximately 7 weeks) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORW Todd Cade, PhD
Duke University
Outcome results
None listed