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

February 15, 2008
December 18, 2009
September 2006
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00618670 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Home-based vs. Supervised Exercise for People With Claudication
Home-based vs. Supervised Exercise for Claudicants

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Intermittent Claudication
  • Behavioral: Walking Exercise
    Three times per week for 3 months
  • Behavioral: Control--Resistance Training
    Three times per week for 3 months
  • 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
    Intervention: Behavioral: Walking Exercise
  • 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
    Intervention: Behavioral: Walking Exercise
  • Active Comparator: 3
    Light resistance training without any walking exercise
    Intervention: Behavioral: Control--Resistance Training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
111
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
35 Years and older
No
Contact: Polly Montgomery, MS 405-271-6764 ext 42719 polly-montgomery@ouhsc.edu
United States
 
NCT00618670
AG0095, R01-AG-24296
Yes
Andrew W. Gardner, PhD, University of Oklahoma Health Sciences Center
National Institute on Aging (NIA)
Oklahoma Center for the Advancement of Science and Technology
Principal Investigator: Andrew W Gardner, PhD University of Oklahoma
National Institute on Aging (NIA)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP