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Clinical Trials/NCT02310256
NCT02310256
Completed
Not Applicable

A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training

Norwegian University of Science and Technology1 site in 1 country30 target enrollmentNovember 2014
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ConditionsIntermittent Claudication

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intermittent Claudication
Sponsor
Norwegian University of Science and Technology
Enrollment
30
Locations
1
Primary Endpoint
absolute walking distance (meters) as measured by 6 minute walking test
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
March 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Diagnosed with intermittent claudication secondary to vascular insufficiency
  • •An ankle-brachial index between 0.4 and 0.9.

Exclusion Criteria

  • •Diagnosed with critical limb ischemia
  • •Ankle-brachial index (ABI) \> 0.90 or \< 0.4
  • •Limited exercise tolerance
  • •Warfarin or heparin usage
  • •Underwent a vascular intervention in the last 6 months
  • •Active cancer, renal- or liver disease

Outcomes

Primary Outcomes

absolute walking distance (meters) as measured by 6 minute walking test

Time Frame: 8 weeks

treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test

mitochondrial function measured by respirometry

Time Frame: 8 weeks

Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry

Secondary Outcomes

  • Peak oxygen uptake measured by cardio-pulmonal exercise testing(8 weeks)
  • Quality of life assessed by SF 36 and CLAU-S questionnaires(8 weeks)
  • Arterial bloodflow measured by plethysmography(8 weeks)

Study Sites (1)

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