Improving walking capacity in patients with intermittent claudication through exercise training

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a home-based exercise program called 'five plus training' compared to standard walking recommendations for patients with intermittent claudication. Participants will be randomized to either perform calf raises with wall support until they experience pain or to walk for at least 30 minutes three times a week. The primary outcomes will include changes in absolute walking distance on a treadmill, quality of life assessments, and measurements of the Ankle-brachial index. The goal is to determine if the specialized exercise regimen leads to greater improvements in walking capacity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pain in the calves after 300 m, or less measured on a treadmill
2. Stable symptoms last 6 months or more
3. The pain must be gone within 5 minutes after the patients stop walking
4. Ankle-Brachial index at 0.7 or lower at rest
5. Using statins and antiplatelet drugs since at least 3 months
6. age\> 18 years
7. Signed consent

Exclusion Criteria:

1. pain in the hips or elsewhere outside the calves while walking
2. Remaining pain more than 5 minutes after stopped walking.
3. Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
4. Use of statins and antiplatelet drugs less than 3 months
5. symptoms less than 6 months
6. Diabetes measured with HbA1c being over 48 mmol/mol (6%)
7. Revascularisation the last 6 months
8. Pain in the calves after longer than 300 m measured on a treadmill
9. Reduced mobility in the ankles
10. Reduced physical ability to perform a test on a treadmill.
11. Age less than 18 years
12. General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
13. No Signed consent

Where it's running

• Ålesund Sykehus
  Ålesund, Norway Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting
• Vestre Viken, Drammen sykehus
  Drammen, Norway Recruiting
• Sykehuset Østfold Kalnes
  Grålum, Norway Recruiting
• Sykehuset Innlandet HF
  Hamar, Norway Recruiting
• Sørlandet Sykehus HF Kristiansand
  Kristiansand, Norway Recruiting

Study contacts

• Principal investigator: Joakim Nordanstig, Professor — Sahlgrenska University Hospital
• Study coordinator: Erney Mattsson, Professor
• Email: erney.mattsson@gmail.com
• Phone: 0046737854490

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.