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Home-based vs. Supervised Exercise for People With Claudication

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking Exercise
Control--Resistance Training
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring aging, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder, muscle function, muscle strength, quality of life

Eligibility Criteria

35 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • General Clinical Research Center, University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

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

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

Light resistance training without any walking exercise

Outcomes

Primary Outcome Measures

Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain

Secondary Outcome Measures

Change in walking efficiency
Change in calf muscle circulation and calf muscle oxygen
Change in health-related quality of life

Full Information

First Posted
February 15, 2008
Last Updated
March 30, 2018
Sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00618670
Brief Title
Home-based vs. Supervised Exercise for People With Claudication
Official Title
Home-based vs. Supervised Exercise for Claudicants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology, National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
aging, gait, musculoskeletal disorder therapy, peripheral blood vessel disorder, muscle function, muscle strength, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Experimental
Arm Description
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
Arm Title
3
Arm Type
Active Comparator
Arm Description
Light resistance training without any walking exercise
Intervention Type
Behavioral
Intervention Name(s)
Walking Exercise
Intervention Description
Three times per week for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Control--Resistance Training
Intervention Description
Three times per week for 3 months
Primary Outcome Measure Information:
Title
Change in the walking distance to onset of leg pain, and the change in walking distance to maximal leg pain
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in walking efficiency
Time Frame
3 months
Title
Change in calf muscle circulation and calf muscle oxygen
Time Frame
3 months
Title
Change in health-related quality of life
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W Gardner, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center, University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7674529
Citation
Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
Results Reference
background
PubMed Identifier
11454114
Citation
Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.
Results Reference
background
PubMed Identifier
12042688
Citation
Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8. doi: 10.1097/00008483-200205000-00011.
Results Reference
background
PubMed Identifier
14981444
Citation
Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. doi: 10.1016/j.jvs.2003.08.037.
Results Reference
background
PubMed Identifier
16242558
Citation
Gardner AW, Montgomery PS, Flinn WR, Katzel LI. The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. J Vasc Surg. 2005 Oct;42(4):702-9. doi: 10.1016/j.jvs.2005.05.049.
Results Reference
background
PubMed Identifier
30922751
Citation
Gardner AW, Parker DE, Montgomery PS. Changes in vascular and inflammatory biomarkers after exercise rehabilitation in patients with symptomatic peripheral artery disease. J Vasc Surg. 2019 Oct;70(4):1280-1290. doi: 10.1016/j.jvs.2018.12.056. Epub 2019 Mar 25.
Results Reference
derived
PubMed Identifier
28116164
Citation
Gardner AW, Parker DE, Montgomery PS. Predictors of Improved Walking after a Supervised Walking Exercise Program in Men and Women with Peripheral Artery Disease. Int J Vasc Med. 2016;2016:2191350. doi: 10.1155/2016/2191350. Epub 2016 Dec 25.
Results Reference
derived
PubMed Identifier
26240075
Citation
Gardner AW, Parker DE, Montgomery PS. Sex-specific predictors of improved walking with step-monitored, home-based exercise in peripheral artery disease. Vasc Med. 2015 Oct;20(5):424-31. doi: 10.1177/1358863X15596237. Epub 2015 Aug 3.
Results Reference
derived
PubMed Identifier
25237048
Citation
Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.
Results Reference
derived
PubMed Identifier
24102029
Citation
Gardner AW, Alaupovic P, Parker DE, Montgomery PS, Esponda OL, Casanegra AI. Influence of peripheral artery disease and statin therapy on apolipoprotein profiles. Int J Vasc Med. 2013;2013:548764. doi: 10.1155/2013/548764. Epub 2013 Sep 11.
Results Reference
derived
PubMed Identifier
21262997
Citation
Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.
Results Reference
derived

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Home-based vs. Supervised Exercise for People With Claudication

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