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Completed

NCT Number: NCT00654810

Exercise Rehabilitation of Younger and Older People With Claudication

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.

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking exercise

Behavioral

Intermittent treadmill walking to near maximal claudication pain three days per week

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Changes in cardiopulmonary function, calf muscle circulation, and health-related quality of life.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Important dates

Study start
1994
Primary completion
2000
Study completion
2000
First posted
Apr 9, 2008
Registry last updated
Apr 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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