Exercise Rehabilitation of Younger and Older People With Claudication

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00654810
First received: April 7, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.


Condition Intervention
Intermittent Claudication
Behavioral: Walking Exercise

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: Exercise Rehabilitation of Younger and Older People With Claudication

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: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: February 1994
Study Completion Date: January 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Low intensity group (40% of maximal exercise capacity)
Behavioral: Walking Exercise
Intermittent treadmill walking to near maximal claudication pain three days per week
Experimental: 2
High intensity group (80% of maximal exercise capacity)
Behavioral: Walking Exercise
Intermittent treadmill walking to near maximal claudication pain three days per week

Detailed Description:

Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of intermittent claudication
  • Exercise tolerance limited by intermittent claudication during a screening treadmill test
  • Ankle/brachial index (ABI) at rest less than 0.90
  • Live independently at home

Exclusion Criteria:

  • Absence of PAD (peripheral artery disease)
  • Asymptomatic PAD (Fontaine stage I)
  • Rest pain PAD (Fontaine stage III)
  • Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
  • Active cancer, renal disease, or liver disease
  • Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication
  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: NCT00654810

Locations
United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
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: NCT00654810     History of Changes
Other Study ID Numbers: AG0097, K01-AG-00657
Study First Received: April 7, 2008
Last Updated: April 7, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
functional ability
gait
musculoskeletal disorder therapy
peripheral blood vessel disorder

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

ClinicalTrials.gov processed this record on July 23, 2014