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Polestriding Versus Walking for Subjects With Poor Leg Circulation

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Eileen G. Collins, University of Illinois
ClinicalTrials.gov Identifier:
NCT00719355
First received: July 17, 2008
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
 Behavioral: Walking with poles
Behavioral: Walking exercise
 Phase 2

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: Polestriding Versus Walking for PAD Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Onset of Claudication Pain During Constant Work Rate Treadmill Test [ Time Frame: At 24 weeks ] [ Designated as safety issue: No ]
    Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.


Enrollment: 146
Study Start Date: June 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walking with Poles
Patients were assigned to a 24 week walking with poles program of rehabilitation. The intervention was the additional of poles to the walking program.
 Behavioral: Walking with poles
Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
Other Name: Exercise
Active Comparator: Traditional walking program
Patients were assigned to a 24 week traditional walking program.
 Behavioral: Walking exercise
Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Other Name: Exercise

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719355

Locations
United States, Illinois
Edward Hines Jr. VA Hospital
Hines, Illinois, United States, 60141
Sponsors and Collaborators
University of Illinois
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Eileen Collins, RN, PhD University of Illinois
  More Information

Publications:

Responsible Party: Eileen G. Collins, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT00719355     History of Changes
Other Study ID Numbers: 2004-0477, R01NR008877
Study First Received: July 17, 2008
Results First Received: May 15, 2012
Last Updated: February 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013