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Recruiting Not applicable

Exercise Training Study of Patients With Claudicatio Intermittens

NCT06448390 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2024-01-01
Last updated
2025-06-06

Condition(s) studied

Claudication, Intermittent

Investigational drug(s) / intervention(s)

Physical training

Physical training: The patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • walking distance — 12 weeks
    Measured on a tread mill before and after the training period
  • Quality of life — 12 weeks
    Measured with a questionnaire (VASCUQOL-6) before and after the training period

Trial sites (14)

FacilityCityRegionStatus
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
Ahus University Hospital Oslo Norway Recruiting
Oslo university Hospital Oslo Norway Recruiting
Stavanger University Hospital Stavanger Norway Recruiting
St Olavs University Hospital Trondheim Norway Recruiting
Sykehuset i Vestfold HF Tønsberg Norway Recruiting
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Linköping University Hiospital Linköping Sweden Recruiting
Karolinska Institute Stockholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06448390 on ClinicalTrials.gov ↗ ← All trials in Sweden