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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG057693-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.
Walking exercise is first-line therapy for PAD. However, many PAD patients are unable or unwilling to exercise. Therefore, in people with PAD, the investigators will determine whether intermittent pneumatic compression augments the benefits of exercise and whether intermittent pneumatic compression alone improves walking performance compared to sham control. The investigators will conduct a randomized trial (2 x 2 factorial design) of 230 PAD participants randomized to one of four groups: Group A: intermittent pneumatic compression + exercise; Group B: intermittent pneumatic compression+ "no exercise" control; Group C: sham control + exercise; and Group D: sham control + "no exercise" control. The intermittent pneumatic compression and sham interventions will be delivered for six months. The primary outcome is change in six-minute walk distance at 6-month follow-up. In secondary aims, the investigators will determine whether the benefits of intermittent pneumatic compression persist even after intermittent pneumatic compression is discontinued and delineate mechanisms by which intermittent pneumatic compression affects walking performance, by measuring changes in MRI-measured calf muscle perfusion and physical activity. The investigators will determine whether intermittent pneumatic compression improves systemic endothelial function, by measuring changes in brachial artery flow-mediated dilation (FMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPC + exercise | Experimental | Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be helped to engage in home-based walking exercise therapy. |
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| IPC + "no exercise" control | Experimental | Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be asked to participate in an educational/informational intervention consisting of an attention control intervention |
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| sham control + exercise | Active Comparator | Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants in this group will be helped to engage in home-based walking exercise therapy. |
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| sham control + "no exercise" control | Active Comparator | Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants will be asked to participate in an educational/informational intervention, designed as an attention control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent pneumatic compression | Device | Intermittent pneumatic compression is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 120 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression combined with exercise improves the 6-minute walk at 6-month follow-up compared to exercise alone. | Baseline to 6-month follow-up |
| Six-minute walk distance (intermittent pneumatic compression therapy alone (without exercise) vs. sham alone (without exercise) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone (without exercise) improves the 6-minute walk at 6-month follow-up, compared to the sham control alone (without exercise). | Baseline to 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves the six-minute walk at 12-month follow-up, 6 months after the intermittent pneumatic compression therapy intervention is completed, compared to exercise alone. | Baseline to 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial biogenesis (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves mitochondrial biogenesis (PGC-1α) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI >0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI >0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary McDermott, MD | Northwestern Universtiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36588397 | Derived | Nayak P, Polonsky T, Tian L, Greenland P, Xu S, Zhang D, Zhao L, Criqui MH, Kibbe MR, Gladders B, Goodney P, Ho K, Guralnik JM, McDermott MM. Medical therapies, comorbid conditions, and functional performance in people with peripheral artery disease enrolled in clinical trials between 2004 and 2021. Vasc Med. 2023 Apr;28(2):144-146. doi: 10.1177/1358863X221145533. Epub 2023 Jan 1. |
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Group assignment regarding the intermittent pneumatic compression device is double-blinded and neither investigators nor participants in the study will know which intermittent pneumatic compression device each participant has (therapeutic intervention vs. sham). Participants will be aware of their exercise group assignment after randomization, but the study coordinators collecting follow-up data will be unaware of each participant's group assignment.
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| exercise | Behavioral | Participants will be asked to walk for exercise five days/week, working up to 50 minutes of exercise per day. The intervention includes a) group meetings at the medical center with the coach and other PAD participants; b) regularly scheduled individual telephone check-in by the coach c) weekly remote monitoring by the coach; d) use of the activity monitor to monitor exercise intensity and duration. |
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| Sham device | Device | The sham control device is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 25 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour. |
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| Health Education | Behavioral | Participants attend health-education lectures and receive telephone calls at the same frequency as the exercise group. On-site lectures are delivered by faculty and staff at the medical center. Telephone calls review health-related handouts from the NIA website that are mailed in advance of the telephone call. Content does not include exercise information. |
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| Six-minute walk distance (IPC only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves the six-minute walk distance at 12-month follow-up, 6 months after the intermittent pneumatic compression therapy intervention is completed, compared to the sham control. | Baseline to 12-month follow-up |
| Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves calf muscle perfusion at 6-month follow-up, compared to exercise alone. | Baseline to 6-month follow-up |
| Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves brachial artery FMD at 6-month follow-up, compared to exercise alone. | Baseline to 6-month follow-up |
| Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves physical activity measured by Actigraph activity monitor at 6-month follow-up, compared to exercise alone. | Baseline to 6-month follow-up |
| Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves calf muscle perfusion at 12-month follow-up, compared to exercise alone. | Baseline to 12-month follow-up |
| Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves brachial artery FMD at 12-month follow-up, compared to exercise alone. | Baseline to 12-month follow-up |
| Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves physical activity measured by Actigraph activity monitor at 12-month follow-up, compared to exercise alone. | Baseline to 12-month follow-up |
| Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves calf muscle perfusion at 6-month follow-up, compared to the sham control. | Baseline to 6-month follow-up |
| Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves brachial artery FMD at 6-month follow-up, compared to the sham control. | Baseline to 6-month follow-up |
| Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves physical activity measured by Actigraph activity monitor at 6-month follow-up, compared to the sham control. | Baseline to 6-month follow-up |
| Calf muscle perfusion (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves calf muscle perfusion at 12-month follow-up, compared to the sham control. | Baseline to 12-month follow-up |
| Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves brachial artery FMD at 12-month follow-up, compared to the sham control. | Baseline to 12-month follow-up |
| Physical Activity measured by Actigraph activity monitor (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves physical activity measured by Actigraph activity monitor at 12-month follow-up, compared to the sham control. | Baseline to 12-month follow-up |
| Mitochondrial activity (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves mitochondrial activity (Cytochrome C oxidase) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Vascular endothelial growth factor abundance (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves vascular endothelial growth factor abundance at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Anti-oxidant enzyme activity (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves anti-oxidant enzyme activity (MnSOD) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Immunohistochemistry-measured mitochondrial activity (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves immunohistochemistry-measured mitochondrial activity (COX and SDH) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Autophagy (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves autophagy (LC3, LAMP2, PARKIN) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Capillary density (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves capillary density (CD31) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Satellite cell content (intermittent pneumatic compression therapy + exercise v. exercise only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy combined with exercise improves satellite cell content (Pax7) at 6-month follow- up, compared to exercise alone. | Baseline to 6-month follow-up |
| Mitochondrial biogenesis (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves mitochondrial biogenesis (PGC-1α) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Mitochondrial activity (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves mitochondrial activity (Cytochrome C oxidase) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Vascular endothelial growth factor abundance (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves vascular endothelial growth factor abundance at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Anti-oxidant enzyme activity (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves anti-oxidant enzyme activity (MnSOD) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Immunohistochemistry-measured mitochondrial activity (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves immunohistochemistry-measured mitochondrial activity (COX and SDH) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Autophagy (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves autophagy (LC3, LAMP2, PARKIN) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Capillary density (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves capillary density (CD31) at 6-month follow- up, compared to the sham control. | Baseline to 6-month follow-up |
| Satellite cell content (intermittent pneumatic compression therapy only v. sham only) | Among PAD participants, the investigators will determine whether intermittent pneumatic compression therapy alone improves satellite cell content (Pax7) at 6-month follow- up, compared to the sham control | Baseline to 6-month follow-up |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D048228 | Intermittent Pneumatic Compression Devices |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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