Activity To Improve Outcomes in Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2023-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multifactor Risk Reduction for Optimal Management of PAD

NCT00537225

Peripheral Arterial Disease

COMPLETED NA

Micro- and Macrovascular Adaptations in Patients With Peripheral Arterial Disease During Supervised Exercise Therapy

NCT00675402

PAOD (Peripheral Arterial Obstructive Disease)

UNKNOWN

Impact and Safety of Blood Flow Restriction in Patients With Peripheral Arterial Occlusive Disease

NCT07043114

PAOD (Peripheral Arterial Obstructive Disease)

COMPLETED NA

Improving Walking in Peripheral Artery Disease

NCT05103280

Peripheral Artery Disease

COMPLETED NA

Evaluation of FM220 in Patients With Peripheral Arterial Disease (PAD)

NCT00146666

Peripheral Arterial Disease Intermittent Claudication

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.

We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Occlusive Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Ad lib activity at home

Group Type ACTIVE_COMPARATOR

Ad lib activity at home

Intervention Type OTHER

Ad lib activity at home

Active Exercise

Active exercise on treadmill

Group Type EXPERIMENTAL

Active Exercise

Intervention Type OTHER

Active exercise on a treadmill

Neuromuscular electrical stimulation

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type OTHER

Neuromuscular electrical stimulation

Weight loss and active exercise

Weight loss plus active exercise on treadmill

Group Type EXPERIMENTAL

Weight loss and active exercise

Intervention Type OTHER

Weight loss and active exercise on a treadmill

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active Exercise

Active exercise on a treadmill

Intervention Type OTHER

Neuromuscular electrical stimulation

Intervention Type OTHER

Weight loss and active exercise

Weight loss and active exercise on a treadmill

Intervention Type OTHER

Ad lib activity at home

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 21-90 years
* Ankle brachial index \< 0.9

Exclusion Criteria

* Cancer under active treatment, except prostate, skin, and hematologic cancers
* Planned for open lower extremity bypass surgery
* Body mass index \>45
* Lower extremity gangrene

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No