NCT02189018

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

8.9 years

First QC Date

July 10, 2014

Last Update Submit

July 26, 2023

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial diseaseEndovascularExercisePerfusionFunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Lower extremity perfusion

    Ankle brachial index and ultrasound quantification of muscle perfusion

    6 months

Secondary Outcomes (1)

  • Functional capacity

    6 months

Study Arms (4)

Control

ACTIVE COMPARATOR

Ad lib activity at home

Other: Ad lib activity at home

Active Exercise

EXPERIMENTAL

Active exercise on treadmill

Other: Active Exercise

Neuromuscular electrical stimulation

EXPERIMENTAL

Neuromuscular electrical stimulation

Other: Neuromuscular electrical stimulation

Weight loss and active exercise

EXPERIMENTAL

Weight loss plus active exercise on treadmill

Other: Weight loss and active exercise

Interventions

Active ExerciseOTHER

Active exercise on a treadmill

Active Exercise
Neuromuscular electrical stimulationOTHER

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation
Weight loss and active exerciseOTHER

Weight loss and active exercise on a treadmill

Weight loss and active exercise
Ad lib activity at homeOTHER

Ad lib activity at home

Control

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VAMC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1Peripheral Arterial DiseaseMotor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Brajesh K Lal, MD

    Baltimore VAMC, University of Maryland School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 14, 2014

Study Start

August 1, 2014

Primary Completion

July 4, 2023

Study Completion

July 4, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

US(1)