Improving Functioning in Peripheral Arterial Disease

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary McDermott, Northwestern University
ClinicalTrials.gov Identifier:
NCT00106327
First received: March 22, 2005
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease.


Condition Intervention
Cardiovascular Diseases
Peripheral Vascular Diseases
Behavioral: Exercise
Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Functioning in Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Six-minute walk distance [ Time Frame: Measured at baseline and follow-up study visits ] [ Designated as safety issue: No ]
  • Summary performance score [ Time Frame: Measured at baseline and follow-up study visits ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: September 2003
Study Completion Date: March 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6-month supervised treadmill exercise program
Behavioral: Exercise
6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program.
Experimental: 2
6-month supervised lower extremity progressive resistance training program
Behavioral: Exercise
6 months of supervised treadmill exercise or strength training, three times per week, followed by a 6 month home-based program.
Active Comparator: 3
Diet/nutrition control group
Behavioral: Diet
11 nutrition education sessions

Detailed Description:

BACKGROUND:

Previous work demonstrates that functional limitations associated with peripheral arterial disease (PAD) are diverse and include slower walking speed, poorer walking endurance, and impaired balance as compared to persons without PAD. Although treadmill-walking exercise improves treadmill performance in patients with intermittent claudication (IC), treadmill performance does not correlate well with community walking ability in older men and women. In older patient populations without PAD, resistance training improves functioning and walking endurance, but this mode of exercise has not been sufficiently studied in PAD. Furthermore, although 65% to 70% of men and women with PAD are either asymptomatic or have exertional leg symptoms other than IC, no prior studies have assessed the effects of exercise interventions in PAD patients who do not have IC.

DESIGN NARRATIVE:

The randomized, control study will determine whether a 6-month supervised treadmill exercise program and a supervised lower extremity progressive resistance training program, respectively, improve lower extremity functioning compared to a nutrition control group among 150 PAD patients with and without IC. The investigators hypothesize that participants in the treadmill walking exercise program and participants in the progressive resistance training program, respectively, will experience greater improvement in functional outcomes than participants in the nutrition control group. The primary functional outcome measures in descending order of importance are 6-minute walk distance and the summary performance score. The summary performance score is a composite measure of lower extremity functioning (usual walking speed, standing balance, and time required for five repeated chair rises) measured on a 0-12 scale that predicts future risk of nursing home placement, mobility loss, and mortality. The study will also identify mechanisms by which the exercise interventions improve functioning in PAD. Mechanisms to be studied include changes in blood viscosity, calf blood flow, brachial artery endothelial reactivity, and inflammatory cytokine levels. By identifying the optimal exercise program for improving functioning in PAD patients with and without IC, the findings will have substantial clinical and public health implications for millions of patients with PAD.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 150 peripheral arterial disease patients with and without IC

Exclusion Criteria:

  • Below or above-knee amputation
  • Wheelchair confinement
  • Inability to walk on a treadmill or inability to perform progressive resistance training
  • Inability to return to the medical center three times weekly for 6 months
  • Walking impairment due to a cause other than PAD
  • Class II New York Heart Association (NYHA) heart failure or angina (heart failure or angina occurring at rest or with minimal exertion)
  • Planned lower extremity revascularization or any other major surgery within 12 months
  • Any increase in anginal symptoms during the previous 6 months or angina at rest
  • Subjects with silent coronary ischemia, defined as ST segment depression greater than or equal to 1 mm during baseline exercise treadmill test without associated chest discomfort, unless they have had a normal perfusion stress test during the previous 6 months
  • Subjects with left-bundle branch block or significant ST-T wave changes on their baseline ECG who do not have a perfusion stress test demonstrating absence of reversible ischemia within the previous 6 months
  • Lower extremity revascularization, major orthopedic surgery, or other major surgery during the previous 3 months
  • Myocardial infarction or coronary artery bypass grafting during the previous 3 months
  • Major medical illnesses that may interfere with subject's ability to complete the interventions and/or follow-up testing
  • Current foot ulcer
  • ABI greater than 0.95
  • Life expectancy less than 12 months
  • Does not speak English
  • Patient is currently involved in another clinical trial
  • Dementia
  • Poorly controlled blood pressure
  • Current significant exercise, defined as exercising three times weekly for 30 minutes with sufficient exertion to produce a sweat or other exercise that is comparable to the exercise interventions offered in our protocol
  • Treatment for cancer (other than non-melanoma skin cancer) during the past 12 months (including radiation therapy, chemotherapy, or surgery)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106327

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611-3008
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Mary McDermott, MD Northwestern University Feinberg School of Medicine
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary McDermott, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT00106327     History of Changes
Other Study ID Numbers: 171, R01HL073351, R01 HL073351
Study First Received: March 22, 2005
Last Updated: July 24, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 31, 2014