230 Participants Needed

Intermittent Pneumatic Compression + Exercise for Peripheral Arterial Disease

(INTERCEDE Trial)

Recruiting at 3 trial locations
KD
Overseen ByKathryn Domanchuk, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you started taking cilostazol within the last three months, you may need to wait until three months have passed to be eligible.

Is the combination of exercise and intermittent pneumatic compression safe for humans?

The research articles provided do not contain specific safety data for the combination of exercise and intermittent pneumatic compression in humans.12345

How does the treatment of Intermittent Pneumatic Compression + Exercise for Peripheral Arterial Disease differ from other treatments?

This treatment is unique because it combines exercise with intermittent pneumatic compression (IPC), which uses a device to apply pressure to the legs, improving blood flow and oxygenation. Unlike other treatments, IPC mimics the natural pumping action of walking, potentially enhancing circulation and reducing symptoms like claudication (pain caused by too little blood flow).678910

What data supports the effectiveness of this treatment for Peripheral Arterial Disease?

Research shows that intermittent pneumatic compression (IPC) can improve blood flow and walking ability in people with peripheral arterial disease (PAD). Studies found that IPC enhances leg blood flow and can help reduce symptoms like pain during walking, known as claudication.6891112

Who Is on the Research Team?

MM

Mary McDermott, MD

Principal Investigator

Northwestern Universtiy

Are You a Good Fit for This Trial?

This trial is for individuals with Peripheral Artery Disease (PAD), confirmed by an ankle-brachial index (ABI) of ≤0.90, or other vascular/angiographic evidence. Exclusions include wheelchair users, BMI >45 kg/m2, significant visual impairment affecting walking, non-English speakers, recent amputees or clinical trial participants, certain cognitive impairments and severe medical conditions.

Inclusion Criteria

I have been diagnosed with PAD based on specific tests.
I have PAD, confirmed by an ABI test or other vascular or angiographic evidence.

Exclusion Criteria

I use a wheelchair for mobility.
You are already exercising regularly or have participated in exercise rehabilitation in the last three months.
Your Mini-Mental Status Examination (MMSE) score is less than 23, or you have dementia.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent pneumatic compression and/or sham therapy, with or without exercise, for six months

6 months
Regular home-based sessions

Follow-up

Participants are monitored for changes in walking endurance and other health metrics after treatment

6 months
Follow-up assessments at 6 and 12 months

Long-term Follow-up

Participants are assessed for the persistence of treatment benefits and additional health outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Exercise
  • Intermittent Pneumatic Compression
Trial Overview The INTERCEDE trial tests if intermittent pneumatic compression combined with walking exercise improves walking endurance in PAD patients over six months versus a sham device plus exercise. It also examines the lasting effects after treatment ends.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: IPC + exerciseExperimental Treatment2 Interventions
Group II: IPC + "no exercise" controlExperimental Treatment2 Interventions
Group III: sham control + exerciseActive Control2 Interventions
Group IV: sham control + "no exercise" controlActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Published Research Related to This Trial

Intermittent pneumatic foot compression (IPC(foot)) significantly increased popliteal artery blood flow in both normal individuals (by 111%) and patients with intermittent claudication (by 51%), indicating its potential efficacy in improving circulation.
The mechanism behind this increased blood flow appears to be the reduction of peripheral resistance, as evidenced by changes in pulsatility index and end diastolic velocity, suggesting that IPC(foot) could be beneficial for managing peripheral vascular disease.
Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics.Delis, KT., Labropoulos, N., Nicolaides, AN., et al.[2016]
Intermittent pneumatic compression (IPC) significantly enhances venous outflow in both healthy individuals and claudicants, with IPC targeting both the foot and calf (IPC(foot+calf)) showing the greatest improvement in blood flow.
Increasing the pressure from 120 mmHg to 180 mmHg in IPC applied to the foot only provided minimal additional benefits, indicating that the combination of foot and calf compression is the most effective method for improving leg inflow.
Enhancing venous outflow in the lower limb with intermittent pneumatic compression. A comparative haemodynamic analysis on the effect of foot vs. calf vs. foot and calf compression.Delis, KT., Slimani, G., Hafez, HM., et al.[2016]
In a study of 37 patients with intermittent claudication, those using intermittent pneumatic foot compression (IPC(foot)) for 4.5 months saw a 146% increase in initial claudication distance and a 106% increase in absolute claudication distance, indicating significant improvement in walking ability.
IPC(foot) also led to substantial increases in ankle brachial indices and popliteal artery volume flow, suggesting enhanced blood flow and collateral circulation, with benefits persisting for at least 12 months after treatment.
Improving walking ability and ankle brachial pressure indices in symptomatic peripheral vascular disease with intermittent pneumatic foot compression: a prospective controlled study with one-year follow-up.Delis, KT., Nicolaides, AN., Wolfe, JH., et al.[2013]

Citations

Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. [2016]
Enhancing venous outflow in the lower limb with intermittent pneumatic compression. A comparative haemodynamic analysis on the effect of foot vs. calf vs. foot and calf compression. [2016]
Improving walking ability and ankle brachial pressure indices in symptomatic peripheral vascular disease with intermittent pneumatic foot compression: a prospective controlled study with one-year follow-up. [2013]
Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. [2004]
Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease. [2021]
Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. [2022]
Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]
Flexibility: A Hidden But Trainable Morbidity in Pediatric Patients with Congenital Heart Disease. [2023]
Peak oxygen consumption by smartwatches compared with cardiopulmonary exercise test in complex congenital heart disease. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Children with congenital heart disease exhibit seasonal variation in physical activity. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
The acute effects of intermittent pneumatic foot versus calf versus simultaneous foot and calf compression on popliteal artery hemodynamics: a comparative study. [2012]
Examination of a new mobile intermittent pneumatic compression device in healthy adults. [2022]
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