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Exercise for Women With Peripheral Arterial Disease

Primary Purpose

Peripheral Artery Disease, Claudication, Women

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

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women 60 years of age and older having a 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
  • an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test
  • at least one year past menopause

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.)
  • use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
  • cognitive dysfunction (mini-mental state examination score < 24)
  • active cancer, renal disease, or liver disease
  • a calf skin fold measurement > 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
  • pulse arterial oxygen saturation of the index finger < 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange

Sites / Locations

  • Clinical Research Center, Penn State College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised Exercise

Control

Arm Description

Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity.

Light resistance training without any walking

Outcomes

Primary Outcome Measures

Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
Change in 6-minute walk distance

Secondary Outcome Measures

Change in calf muscle oxygen saturation
Change in daily ambulatory activity
Change in walking economy
Change in peak oxygen uptake

Full Information

First Posted
November 15, 2010
Last Updated
February 27, 2019
Sponsor
University of Oklahoma
Collaborators
Oklahoma Center for the Advancement of Science and Technology, Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01241747
Brief Title
Exercise for Women With Peripheral Arterial Disease
Official Title
Exercise for Women With Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 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, Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group. Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Claudication, Women

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Supervised Exercise
Arm Type
Experimental
Arm Description
Supervised program consisting of graded treadmill walking, with progressive increments in exercise duration from 15 to 40 minutes at an exercise intensity of 40% of exercise capacity.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Light resistance training without any walking
Intervention Type
Behavioral
Intervention Name(s)
Walking Exercise
Intervention Description
3 times per week for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Resistance training 3 times per week for 3 months
Primary Outcome Measure Information:
Title
Change in walking distance to onset of leg pain and the change in walking distance to maximal leg pain
Time Frame
3 months
Title
Change in 6-minute walk distance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in calf muscle oxygen saturation
Time Frame
3 months
Title
Change in daily ambulatory activity
Time Frame
3 months
Title
Change in walking economy
Time Frame
3 months
Title
Change in peak oxygen uptake
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women 60 years of age and older having a 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 an ankle/brachial index (ABI) < 0.90 at rest or < 0.73 immediately following the treadmill exercise test at least one year past menopause 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.) use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation) cognitive dysfunction (mini-mental state examination score < 24) active cancer, renal disease, or liver disease a calf skin fold measurement > 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue pulse arterial oxygen saturation of the index finger < 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew W Gardner, PhD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
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
result
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
result
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
result
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
result
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
result

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Exercise for Women With Peripheral Arterial Disease

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