Exercise Training Study of Patients With Claudicatio Intermittens

Not Applicable

Recruiting

• Conditions: Claudication, Intermittent
• Interventions: Behavioral: Physical training

• Registration Number: NCT06448390
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-07
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
walking	Physical training	Walking at least 30 minutes three times per week.
Five plus training	Physical training	During "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.

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (14)

Sørlandet Sykehus HF Kristiansand; 🇳🇴 Kristiansand, Norway

Linköping University Hiospital; 🇸🇪 Linköping, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Ålesund Sykehus; 🇳🇴 Ålesund, Norway

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Ahus University Hospital; 🇳🇴 Oslo, Norway

Oslo university Hospital; 🇳🇴 Oslo, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sykehuset Østfold Kalnes; 🇳🇴 Grålum, Norway

Sykehuset Innlandet HF; 🇳🇴 Hamar, Norway

Vestre Viken, Drammen sykehus; 🇳🇴 Drammen, Norway

St Olavs University Hospital; 🇳🇴 Trondheim, Norway

Sykehuset i Vestfold HF; 🇳🇴 Tønsberg, Norway