Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Claudication, Intermittent
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 100
- Locations
- 14
- Primary Endpoint
- walking distance
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Detailed Description
Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect. The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pain in the calves after 300 m, or less measured on a treadmill
- •Stable symptoms last 6 months or more
- •The pain must be gone within 5 minutes after the patients stop walking
- •Ankle-Brachial index at 0.7 or lower at rest
- •Using statins and antiplatelet drugs since at least 3 months
- •age\> 18 years
- •Signed consent
Exclusion Criteria
- •pain in the hips or elsewhere outside the calves while walking
- •Remaining pain more than 5 minutes after stopped walking.
- •Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
- •Use of statins and antiplatelet drugs less than 3 months
- •symptoms less than 6 months
- •Diabetes measured with HbA1c being over 48 mmol/mol (6%)
- •Revascularisation the last 6 months
- •Pain in the calves after longer than 300 m measured on a treadmill
- •Reduced mobility in the ankles
- •Reduced physical ability to perform a test on a treadmill.
Outcomes
Primary Outcomes
walking distance
Time Frame: 12 weeks
Measured on a tread mill before and after the training period
Quality of life
Time Frame: 12 weeks
Measured with a questionnaire (VASCUQOL-6) before and after the training period