The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication

October 24, 2016 updated by: Norwegian University of Science and Technology
The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinic, vascular surgery, Trondheim, Norway

Description

Inclusion Criteria:

  • A history of any type of uni- or bilateral exertion leg pain.
  • A maximal claudication distance that is less than 300 meter
  • Diagnosed with intermittent claudication secondary to vascular insufficiency
  • An ankle-brachial index between 0.4 and 0.9.
  • Lives in Trondheim

Exclusion Criteria:

  • Diagnosed with critical limb ischemia
  • ankle-brachial index > 0.90 or < 0.4
  • Limited exercise tolerance
  • Warfarin or heparin usage
  • Diabetes mellitus
  • Underwent a vascular intervention in the last 3 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy
Behavioral: exercise
one bout of exercise training
claudication
Behavioral: exercise
one bout of exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitochondrial function
Time Frame: One day
respirometry
One day

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Øyvind Ellingsen, prof, Norwegisn 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

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/395/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.

Clinical Trials on Intermittent Claudication

Clinical Trials on exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe