Exercise and Weight Loss in PAD

NCT02607033 | Completed Results DMC

• 2 other identifiers: E1788-WIK2RX001788-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

Conditions

Peripheral Arterial Disease

Keywords

Exercise; Weight Loss; Mobility Limitation

Outcome Measures

Primary Outcomes (2)

• Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention

  The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention

  6 months

• Difference in Ankle Brachial Index Pre-intervention to Post-intervention

  A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing.

  6 months

Secondary Outcomes (2)

• Score on the Modified Physical Performance Test Post-intervention

  6 months

• Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention

  6 months

Study Arms (2)

Exercise and Weight Loss

EXPERIMENTAL

Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months

Other: Exercise; Other: Weight Loss

Exercise

ACTIVE COMPARATOR

Individuals assigned to this group will be asked to complete the exercise intervention for xic months

Other: Exercise

Interventions

Exercise OTHER

Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.

Exercise; Exercise and Weight Loss

Weight Loss OTHER

Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.

Exercise and Weight Loss

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>25 kg/m2
• Ankle Brachial Index (ABI) \<.90
• Able to participate in a supervised exercise program at the Baltimore VA
• No current plan for surgical revascularization
• Claudication or leg symptoms when walking

You may not qualify if:

• Unstable angina or a recent heart attack
• Active cancer
• Dementia
• Current foot or leg ulcers
• Already exercise 2x/week or more.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity; Weight Loss; Mobility Limitation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Lower recruitment with an overall small sample size limited the number of participants to be analyzed in the study. An unequal drop out rate between the groups also limits interpretation of data at the six-month time point.

Results Point of Contact

• Title: Odessa Addison
• Organization: Baltimore VA Hosptial

odessa.addison@va.gov

4106057000

Study Officials

• Odessa R. Addison, PhD DPT

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 17, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)