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Completed

NCT Number: NCT02310256

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

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.

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Key information

Conditions

Intermittent Claudication Behavior Cardiovascular Diseases Motor Activity Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for circulation and medical imaging, NTNU

Trondheim, Postboks 8905, 7491, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Five plus exercise training

Other

calf raise exercise

Primary outcomes

  1. absolute walking distance (meters) as measured by 6 minute walking test

    Time frame: 8 weeks

    treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test

  2. mitochondrial function measured by respirometry

    Time frame: 8 weeks

    Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry

Secondary outcomes

  1. Arterial bloodflow measured by plethysmography

    Time frame: 8 weeks

    measured by plethysmography

  2. Quality of life assessed by SF 36 and CLAU-S questionnaires

    Time frame: 8 weeks

    assessed by SF 36 and CLAU-S questionnaires

  3. Peak oxygen uptake measured by cardio-pulmonal exercise testing

    Time frame: 8 weeks

    measured by cardio-pulmonal exercise testing

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 8, 2014
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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