Intermittent Pneumatic Compression + Exercise for Peripheral Arterial Disease

(INTERCEDE Trial)

Recruiting at 3 trial locations

Overseen By Kathryn Domanchuk, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Amputation, Critical limb ischemia, Wheelchair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

230 Participants Needed

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. ^{1 2 3 4 5}

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). ^{6 7 8 9 10}

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. ^{6 8 9 11 12}

Who Is on the Research Team?

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.

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?

Group I: IPC + exercise Experimental Treatment 2 Interventions

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.

Group II: IPC + "no exercise" control Experimental Treatment 2 Interventions

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

Group III: sham control + exercise Active Control 2 Interventions

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.

Group IV: sham control + "no exercise" control Active Control 2 Interventions

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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Intermittent pneumatic compression (IPC) of both the foot and calf at pressures of 120-140 mmHg and a frequency of 3-4 impulses per minute significantly reduces venous pressure, which can enhance blood flow and improve walking ability in individuals with claudication.

The study found that a one-second delay between calf and foot compression was more effective than shorter delays, indicating that timing is crucial for maximizing the benefits of IPC in improving peripheral hemodynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. Delis, KT., Azizi, ZA., Stevens, RJ., et al.[2004]

The novel intermittent pneumatic compression (IPC) device (Gradient Pump) significantly increased foot oxygenation in patients with severe peripheral arterial disease (PAD), while the traditional sequential foot-calf device showed a decrease in oxygenation.

The Gradient Pump also led to significant improvements in haemodynamics, such as increased blood flow and velocity in the popliteal artery, and had higher patient compliance compared to the traditional device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease. Manfredini, F., Malagoni, AM., Felisatti, M., et al.[2021]

The incremental shuttle walking test effectively stratifies mortality risk in patients with pulmonary arterial hypertension (PAH), with a significant reduction in 1-year mortality observed as walking distance increases, from 32% at ≤30 meters to 1% at ≥430 meters.

This study analyzed data from 1,847 PAH patients and established specific distance thresholds for risk categorization, which can be integrated into existing risk assessment tools, demonstrating the test's potential as a simple and effective alternative to traditional maximal exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. Lewis, RA., Billings, CG., Hurdman, JA., et al.[2022]

Youth with congenital heart disease (CHD) often have reduced exercise capacity and lower quality of life, highlighting the need for effective exercise interventions, particularly home-based programs that can be monitored via telemedicine.

A new 12-week randomized crossover trial is being conducted to evaluate the effectiveness of a home-based high-intensity interval training program using a video game-linked cycle ergometer, which may provide better cardiorespiratory benefits compared to traditional moderate-intensity exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Spence, C., Khoo, N., Mackie, A., et al.[2023]

Pediatric patients with congenital heart disease (CHD) demonstrated significantly lower flexibility compared to the general population, with a baseline sit-and-reach score of 24.3 cm versus the population norm, indicating a need for targeted interventions.

After a 60-day fitness program, flexibility in CHD patients improved to normal levels, suggesting that directed training can effectively enhance flexibility in this population, including those with a history of sternotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexibility: A Hidden But Trainable Morbidity in Pediatric Patients with Congenital Heart Disease. Hansen, K., Curran, T., O'Neill, JA., et al.[2023]

In a study of 48 patients with adult congenital heart disease, peak oxygen consumption (pVO2) measured by smartwatches showed a strong correlation with pVO2 measured during cardiopulmonary exercise tests (CPET), indicating that smartwatches can effectively monitor exercise capacity in this population.

The changes in pVO2 over time were also well correlated between the smartwatch and CPET measurements, suggesting that smartwatches can reliably track improvements or declines in exercise capacity in patients with complex heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak oxygen consumption by smartwatches compared with cardiopulmonary exercise test in complex congenital heart disease. Tran, T., Steiner, JM., Venkateswaran, A., et al.[2023]

A study involving 156 children aged 9-16 years with congenital heart disease showed significant seasonal variations in physical activity levels, with peaks in late spring and autumn and dips during winter and summer school holidays.

Using a commercial activity tracker (Fitbit), the study found that children consistently averaged below 12,000 steps per day throughout the year, highlighting the need for season-specific counseling to encourage physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with congenital heart disease exhibit seasonal variation in physical activity. Kuan, MTY., Voss, C., Lopez, J., et al.[2020]

Intermittent pneumatic compression (IPC) significantly enhances popliteal artery blood flow in both healthy individuals and patients with intermittent claudication, with the greatest increase observed when using simultaneous foot and calf compression (IPC(foot+calf)).

The study found that IPC(foot+calf) not only increased blood flow but also improved blood flow velocity and reduced pulsatility index, suggesting that peripheral vasodilation is the key mechanism behind this effect, highlighting its potential for treating peripheral vascular disease.

NCBI (Pubmed)

pubmed.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. Delis, KT., Nicolaides, AN., Labropoulos, N., et al.[2012]

The study involving 29 healthy volunteers demonstrated that using a portable intermittent pneumatic compression (IPC) device significantly increased tissue oxygenation (StO2), especially in a long-sitting position compared to chair-sitting, with a 12% higher StO2 level post-intervention.

The IPC device not only improved StO2 during the intervention but also maintained elevated levels for up to 15 minutes afterward, suggesting its potential effectiveness in enhancing tissue health and possibly reducing the risk of postoperative deep vein thrombosis (DVT) or inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of a new mobile intermittent pneumatic compression device in healthy adults. Chohan, A., Abram, S., Parkes, A., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effect of intermittent pneumatic foot compression on popliteal artery haemodynamics. [2016]

2. England pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. England pubmed.ncbi.nlm.nih.gov

Optimum intermittent pneumatic compression stimulus for lower-limb venous emptying. [2004]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Flexibility: A Hidden But Trainable Morbidity in Pediatric Patients with Congenital Heart Disease. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Peak oxygen consumption by smartwatches compared with cardiopulmonary exercise test in complex congenital heart disease. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Children with congenital heart disease exhibit seasonal variation in physical activity. [2020]

11. United States pubmed.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]

12. England pubmed.ncbi.nlm.nih.gov

Examination of a new mobile intermittent pneumatic compression device in healthy adults. [2022]