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

Not Applicable

Completed

• Conditions: Intermittent Claudication
• Interventions: Other: Five plus exercise training

• Registration Number: NCT02310256
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-08
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Five Plus	Five plus exercise training	Exercise training

Primary Outcome Measures

Name	Time	Method
absolute walking distance (meters) as measured by 6 minute walking test	8 weeks	treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
mitochondrial function measured by respirometry	8 weeks	Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry

Secondary Outcome Measures

Name	Time	Method
Peak oxygen uptake measured by cardio-pulmonal exercise testing	8 weeks	measured by cardio-pulmonal exercise testing
Quality of life assessed by SF 36 and CLAU-S questionnaires	8 weeks	assessed by SF 36 and CLAU-S questionnaires
Arterial bloodflow measured by plethysmography	8 weeks	measured by plethysmography

Trial Locations

Locations (1)

Department for circulation and medical imaging, NTNU; 🇳🇴 Trondheim, Postboks 8905, Norway