A Clinical Trial on the Effects of Home-based Five Plus Exercise Training

Intermittent Claudication Clinical Trial

Official title:

A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310256
• Other study ID #: 2011/2533/REK midt
• 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
• 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

Related Conditions & MeSH terms

• Intermittent Claudication

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