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

March 28, 2018 updated by: Norwegian University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Postboks 8905
      • Trondheim, Postboks 8905, Norway, 7491
        • Department for circulation and medical imaging, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Active Comparator: Five Plus
Exercise training
Other: Five plus exercise training
calf raise exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
mitochondrial function measured by respirometry
Time Frame: 8 weeks
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial bloodflow measured by plethysmography
Time Frame: 8 weeks
measured by plethysmography
8 weeks
Quality of life assessed by SF 36 and CLAU-S questionnaires
Time Frame: 8 weeks
assessed by SF 36 and CLAU-S questionnaires
8 weeks
Peak oxygen uptake measured by cardio-pulmonal exercise testing
Time Frame: 8 weeks
measured by cardio-pulmonal exercise testing
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Director: Øivind Rognmo, PhD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2533/REK midt

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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