Exercise Training Study of Patients With Claudicatio Intermittens

Last updated: June 3, 2024
Sponsor: Norwegian University of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Peripheral Arterial Occlusive Disease

Intermittent Claudication

Treatment

Physical training

Clinical Study ID

NCT06448390
4/2024
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

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 studyincluding Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .

  13. No Signed consent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Physical training
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Vestre Viken, Drammen sykehus

    Drammen,
    Norway

    Active - Recruiting

  • Sykehuset Østfold Kalnes

    Grålum,
    Norway

    Active - Recruiting

  • Sykehuset Innlandet HF

    Hamar,
    Norway

    Active - Recruiting

  • Sørlandet Sykehus HF Kristiansand

    Kristiansand,
    Norway

    Active - Recruiting

  • Ahus University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Oslo university Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • St Olavs University Hospital

    Trondheim,
    Norway

    Active - Recruiting

  • Sykehuset i Vestfold HF

    Tønsberg,
    Norway

    Active - Recruiting

  • Ålesund Sykehus

    Ålesund,
    Norway

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Linköping University Hiospital

    Linköping,
    Sweden

    Active - Recruiting

  • Karolinska Institute

    Stockholm,
    Sweden

    Active - Recruiting

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