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

Intermittent Claudication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842412
• Other study ID #: 2013/395/REK midt
• Status: Completed
• Phase: Phase 0
• First received: April 25, 2013
• Last updated: October 24, 2016
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Behavioral:
• exercise
one bout of exercise training

Locations

Country	Name	City	State
Norway	Department for circulation and medical imaging, NTNU	Trondheim	Postboks 8905

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

van Schaardenburgh M, Wohlwend M, Rognmo Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial function	respirometry	One day	No