NCT00719355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 28, 2012

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

5.9 years

First QC Date

July 17, 2008

Results QC Date

May 15, 2012

Last Update Submit

February 7, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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).

    Baseline and 24 weeks

Secondary Outcomes (1)

  • Onset of Claudication Pain During Constant Work Rate Treadmill Test

    At 24 weeks

Study Arms (2)

Walking with Poles

EXPERIMENTAL

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

Traditional walking program

ACTIVE COMPARATOR

Patients were assigned to a 24 week traditional walking program.

Behavioral: Walking exercise

Interventions

Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.

Also known as: Exercise
Walking with Poles

Patients walked for 20-45 minutes, 3 times/week for 24 weeks.

Also known as: Exercise
Traditional walking program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

Related Publications (6)

  • Collins EG, Langbein WE, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. Cardiovascular training effect associated with polestriding exercise in patients with peripheral arterial disease. J Cardiovasc Nurs. 2005 May-Jun;20(3):177-85. doi: 10.1097/00005082-200505000-00009.

    PMID: 15870588BACKGROUND
  • Collins EG, Edwin Langbein W, Orebaugh C, Bammert C, Hanson K, Reda D, Edwards LC, Littooy FN. PoleStriding exercise and vitamin E for management of peripheral vascular disease. Med Sci Sports Exerc. 2003 Mar;35(3):384-93. doi: 10.1249/01.MSS.0000053658.82687.FF.

    PMID: 12618567BACKGROUND
  • Langbein WE, Collins EG, Orebaugh C, Maloney C, Williams KJ, Littooy FN, Edwards LC. Increasing exercise tolerance of persons limited by claudication pain using polestriding. J Vasc Surg. 2002 May;35(5):887-93. doi: 10.1067/mva.2002.123756.

    PMID: 12021703BACKGROUND
  • Fritschi C, Collins EG, O'Connell S, McBurney C, Butler J, Edwards L. The effects of smoking status on walking ability and health-related quality of life in patients with peripheral arterial disease. J Cardiovasc Nurs. 2013 Jul-Aug;28(4):380-6. doi: 10.1097/JCN.0b013e31824af587.

  • Collins EG, McBurney C, Butler J, Jelinek C, O'Connell S, Fritschi C, Reda D. The Effects of Walking or Walking-with-Poles Training on Tissue Oxygenation in Patients with Peripheral Arterial Disease. Int J Vasc Med. 2012;2012:985025. doi: 10.1155/2012/985025. Epub 2012 Sep 25.

  • Collins EG, O'connell S, McBurney C, Jelinek C, Butler J, Reda D, Gerber BS, Hurt C, Grabiner M. Comparison of walking with poles and traditional walking for peripheral arterial disease rehabilitation. J Cardiopulm Rehabil Prev. 2012 Jul-Aug;32(4):210-8. doi: 10.1097/HCR.0b013e31825828f4.

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

WalkingExercise

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMotor Activity

Limitations and Caveats

Due to the small number of women in the trial, results cannot be generalized to women.

Results Point of Contact

Title
Eileen G. Collins PhD, RN
Organization
University of Illinois at Chicago

Study Officials

  • Eileen Collins, RN, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

June 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 12, 2013

Results First Posted

September 28, 2012

Record last verified: 2013-02

Locations