Improving walking capacity in patients with intermittent claudication through exercise training

Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training

This study is testing if a special home exercise program can help people with intermittent claudication walk better than just following regular walking guidelines.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Norwegian University of Science and Technology (Academic / other)
• Locations: 14 sites (Ålesund and 13 other locations)
• Trial ID: NCT06448390 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with stable intermittent claudication symptoms and an Ankle-brachial index of 0.7 or lower.

Not a fit: Patients with pain in areas other than the calves, or those with severe comorbid conditions that impair mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the walking ability and quality of life for patients suffering from intermittent claudication.

How similar studies have performed: Previous studies have shown that exercise training can improve outcomes in patients with intermittent claudication, suggesting that this approach may be effective.

Eligibility criteria

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 this trial is running

Ålesund and 13 other locations

• 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)

Study contacts

• Principal investigator: Joakim Nordanstig, Professor — Sahlgrenska University Hospital
• Study coordinator: Erney Mattsson, Professor

Conditions Claudication, Intermittent