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Clinical Trials/NCT00719355
NCT00719355CompletedPhase 2

Polestriding Versus Walking for PAD Rehabilitation

University of Illinois at Chicago2 sites in 1 country146 target enrollmentStarted: June 2005Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
146
Locations
2
Primary Endpoint
Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test

Study Overview

Brief Summary

The purpose of this study is to compare the effects of polestriding (walking with poles) and traditional walking on physical endurance in subjects with poor circulation in their legs. Another goal is to evaluate the effectiveness of a walking program in increasing the amount of oxygen in the calf muscles and therefore improving overall physical activity and quality of life.

Detailed Description

Peripheral Arterial Disease (PAD/PVD) is caused by decreased blood flow to the legs. The most common symptom is intermittent claudication pain during walking that is relieved by rest. Walking is the primary treatment prescribed for PAD rehabilitation. Polestriding uses muscles of the upper and lower body in a continuous movement. Walking with poles increases stride length, cadence and walking speed and decreases ground reaction forces on the joints. Subjects in this study will participate in a walking program with or without poles.

Dr. Collins' research focuses on physical activity interventions to improve the functional status of persons with chronic illness. Several rehabilitation studies have tested the efficacy of walking exercise for patients with PAD. Studies on polestriding indicate that it may be superior to traditional walking, but these two methods have never been compared. Approximately 30% of patients with coronary artery disease have PAD as their only symptom. As the population ages and more people are affected by this debilitating condition, nurse-initiated rehabilitative therapies, such as polestriding, need to be explored. The consent form explains the purpose of the study in addition to the procedures, risks, benefits, options, confidentiality, costs, and compensation. Participants are also asked to sign a HIPPA authorization.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Peripheral Vascular Disease
  • Cramping/Claudication Pain in legs while walking
  • Ankle Brachial Index (measure of circulation by doppler) .90 or less

Exclusion Criteria

  • Ulcers or sores on feet or legs
  • Unable to walk or confined to a wheelchair
  • Amputations or severe arthritis pain in shoulders, knees, or hips
  • Medical conditions which would exclude subject from participating in an exercise program
  • Vascular Surgery within the last six months, or planning vascular surgery

Outcomes

Primary Outcomes

Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test

Time Frame: Baseline and 24 weeks

Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).

Secondary Outcomes

  • Onset of Claudication Pain During Constant Work Rate Treadmill Test(At 24 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eileen G. Collins

Professor

University of Illinois at Chicago

Study Sites (2)

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