Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Home-based vs. Supervised Exercise for People With Claudication

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00618670
First received: February 15, 2008
Last updated: December 18, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to examine the effects of a home-based exercise rehabilitation program compared to a supervised exercise program on intermittent claudication (leg pain or discomfort) and ambulatory function.


Condition Intervention
Intermittent Claudication
Behavioral: Walking Exercise
Behavioral: Control--Resistance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-based vs. Supervised Exercise for Claudicants

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in walking efficiency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in calf muscle circulation and calf muscle oxygen [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in health-related quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 111
Study Start Date: September 2006
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Home-based program with progressive increases in exercise duration and intensity (i.e., cadence); walking duration will be longer for the home-based group because the intensity of walking will be lower than the graded treadmill walking performed by the supervised group
Behavioral: Walking Exercise
Three times per week for 3 months
Experimental: 2
Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes, and progressive increments in exercise intensity from 50 to 70% of exercise capacity
Behavioral: Walking Exercise
Three times per week for 3 months
Active Comparator: 3
Light resistance training without any walking exercise
Behavioral: Control--Resistance Training
Three times per week for 3 months

Detailed Description:

This study seeks to 1) compare the changes in ambulatory function, vascular function, and health-related quality of life in patients limited by intermittent claudication following a home-based exercise rehabilitation program, a supervised exercise program, and a light resistance training exercise program; and 2) determine whether changes in walking efficiency, calf muscle circulation, and calf muscle oxygen are the reasons by which both home-based and supervised exercise rehabilitation improve ambulatory function.

We hypothesize that a home-based exercise program utilizing new physical activity monitoring technology that can accurately quantify exercise adherence as well as the intensity, duration, and volume of exercise sessions will result in similar changes in ambulatory function, vascular function, and health-related quality of life compared to a standard, supervised exercise program. Further, both the home-based and supervised exercise rehabilitation programs will result in greater changes in ambulatory function, vascular function, and health-related quality of life than a light resistance training exercise program. Finally, we hypothesize that the changes in walking efficiency, calf muscle circulation, and calf muscle oxygen will each be predictive of improved ambulation following the home-based exercise program as well as the supervised exercise program.

The 3-month program will consist of walking 3 times per week, with progressive increases in duration and intensity. The two walking exercise programs will be matched on the estimated caloric expenditure during the training sessions. Patients in the control group will perform light resistance training without any walking exercise.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
  • Exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
  • Ankle/brachial index (ABI) less than 0.90 at rest, which decreases to less than 0.73 immediately following the treadmill exercise test

Exclusion Criteria:

  • Absence of PAD (peripheral artery disease)
  • Asymptomatic PAD (Fontaine stage I)
  • Rest pain due to PAD (Fontaine stage III)
  • Tissue loss due to PAD (Fontaine stage IV)
  • Medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
  • Cognitive dysfunction (mini-mental state examination score less than 24)
  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: NCT00618670

Contacts
Contact: Polly Montgomery, MS 405-271-6764 ext 42719 polly-montgomery@ouhsc.edu

Locations
United States, Oklahoma
General Clinical Research Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Andrew W Gardner, PhD    405-271-4272 ext 42743    andrew-gardner@ouhsc.edu   
Contact: Polly S Montgomery, MS    405-271-4272    polly-montgomery@ouhsc.edu   
Principal Investigator: Andrew W Gardner, PhD         
Sub-Investigator: Steven M Blevins, MD         
Sponsors and Collaborators
Oklahoma Center for the Advancement of Science and Technology
Investigators
Principal Investigator: Andrew W Gardner, PhD University of Oklahoma
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew W. Gardner, PhD, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00618670     History of Changes
Other Study ID Numbers: AG0095, R01-AG-24296
Study First Received: February 15, 2008
Last Updated: December 18, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
aging
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder
muscle function
muscle strength
quality of life

Additional relevant MeSH terms:
Intermittent Claudication
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014