The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 25, 2016
October 1, 2016
11 months
April 25, 2013
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mitochondrial function
respirometry
One day
Study Arms (2)
claudication
healthy
Interventions
Eligibility Criteria
Outpatient clinic, vascular surgery, Trondheim, Norway
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
Department for circulation and medical imaging, NTNU
Trondheim, Postboks 8905, 7491, Norway
Related Publications (1)
van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.
PMID: 27760222RESULT
Biospecimen
muscle tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Øyvind Ellingsen, prof
Norwegisn University of Science and Technology
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2013
First Posted
April 29, 2013
Study Start
April 1, 2013
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
October 25, 2016
Record last verified: 2016-10