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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842412
First Posted: April 29, 2013
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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.

Condition Intervention Phase
Intermittent Claudication Behavioral: exercise Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Mitochondrial function [ Time Frame: One day ]
    respirometry


Biospecimen Retention:   Samples Without DNA
muscle tissue

Enrollment: 50
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
claudication Behavioral: exercise
one bout of exercise training
healthy Behavioral: exercise
one bout of exercise training

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient clinic, vascular surgery, Trondheim, Norway
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842412


Locations
Norway
Department for circulation and medical imaging, NTNU
Trondheim, Postboks 8905, Norway, 7491
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Øyvind Ellingsen, prof Norwegisn University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01842412     History of Changes
Other Study ID Numbers: 2013/395/REK midt
First Submitted: April 25, 2013
First Posted: April 29, 2013
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Norwegian University of Science and Technology:
Mitochondria, Muscle
Exercise

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms