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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02310256
Other study ID # 2011/2533/REK midt
Secondary ID
Status Completed
Phase N/A
First received November 10, 2014
Last updated March 28, 2018
Start date November 2014
Est. completion date March 2016

Study information

Verified date March 2018
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosed with intermittent claudication secondary to vascular insufficiency

- An ankle-brachial index between 0.4 and 0.9.

Exclusion Criteria:

- Diagnosed with critical limb ischemia

- Ankle-brachial index (ABI) > 0.90 or < 0.4

- Limited exercise tolerance

- Warfarin or heparin usage

- Underwent a vascular intervention in the last 6 months

- Active cancer, renal- or liver disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Five plus exercise training
calf raise exercise

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Van Schaardenburgh M, Wohlwend M, Rognmo Ø, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9. — View Citation

van Schaardenburgh M, Wohlwend M, Rognmo Ø, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary absolute walking distance (meters) as measured by 6 minute walking test treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test 8 weeks
Primary mitochondrial function measured by respirometry Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry 8 weeks
Secondary Arterial bloodflow measured by plethysmography measured by plethysmography 8 weeks
Secondary Quality of life assessed by SF 36 and CLAU-S questionnaires assessed by SF 36 and CLAU-S questionnaires 8 weeks
Secondary Peak oxygen uptake measured by cardio-pulmonal exercise testing measured by cardio-pulmonal exercise testing 8 weeks
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