Clinical Trials Directory

Trials / Completed

CompletedNCT00618670

Home-based vs. Supervised Exercise for People With Claudication

Home-based vs. Supervised Exercise for Claudicants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
135 (actual)
Sponsor
University of Oklahoma · Academic / Other
Sex
All
Age
35 Years – 100 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWalking ExerciseThree times per week for 3 months
BEHAVIORALControl--Resistance TrainingThree times per week for 3 months

Timeline

Start date
2006-09-01
Primary completion
2016-09-01
Completion
2016-09-01
First posted
2008-02-20
Last updated
2018-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00618670. Inclusion in this directory is not an endorsement.

Home-based vs. Supervised Exercise for People With Claudication (NCT00618670) · Clinical Trials Directory