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

NCT ID: NCT01842412

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intermittent Claudication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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claudication

exercise

Intervention Type BEHAVIORAL

one bout of exercise training

healthy

exercise

Intervention Type BEHAVIORAL

one bout of exercise training

Interventions

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exercise

one bout of exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øyvind Ellingsen, prof

Role: STUDY_DIRECTOR

Norwegisn University of Science and Technology

Locations

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Department for circulation and medical imaging, NTNU

Trondheim, Postboks 8905, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 27760222 (View on PubMed)

Other Identifiers

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2013/395/REK midt

Identifier Type: -

Identifier Source: org_study_id

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