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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

July 17, 2008
February 7, 2013
June 2005
May 2011   (final data collection date for primary outcome measure)
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).
Length of exercise duration on the treadmill constant work rate exercise test [ Time Frame: At 24 and 32 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719355 on ClinicalTrials.gov Archive Site
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.
Decreased amount of claudication pain during constant work rate treadmill test [ Time Frame: At 24 and 32 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Polestriding Versus Walking for Subjects With Poor Leg Circulation
Polestriding Versus Walking for PAD Rehabilitation

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Behavioral: Walking with poles
    Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.
    Other Name: Exercise
  • Behavioral: Walking exercise
    Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
    Other Name: Exercise
  • 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.
    Intervention: Behavioral: Walking with poles
  • Active Comparator: Traditional walking program
    Patients were assigned to a 24 week traditional walking program.
    Intervention: Behavioral: Walking exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719355
2004-0477, R01NR008877
No
Eileen G. Collins, University of Illinois
University of Illinois
National Institute of Nursing Research (NINR)
Principal Investigator: Eileen Collins, RN, PhD University of Illinois
University of Illinois
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP