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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01842412
First received: April 25, 2013
Last updated: March 4, 2014
Last verified: March 2014
  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
Phase 0

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 ] [ Designated as safety issue: No ]
    respirometry


Biospecimen Retention:   Samples Without DNA

muscle tissue


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated 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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01842412     History of Changes
Other Study ID Numbers: 2013/395/REK midt, 2013/395/REK midt
Study First Received: April 25, 2013
Last Updated: March 4, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on April 17, 2014