Exercise Training Study of Patients With Claudicatio Intermittens

Claudication, Intermittent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448390
• Other study ID #: 4/2024
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Norwegian University of Science and Technology
• Contact: Erney Mattsson, Professor
• Phone: 0046737854490
• Email: erney.mattsson[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Norway	Ålesund Sykehus	Ålesund
Norway	Haukeland University Hospital	Bergen
Norway	Vestre Viken, Drammen sykehus	Drammen
Norway	Sykehuset Østfold Kalnes	Grålum
Norway	Sykehuset Innlandet HF	Hamar
Norway	Sørlandet Sykehus HF Kristiansand	Kristiansand
Norway	Ahus University Hospital	Oslo
Norway	Oslo university Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	Sykehuset i Vestfold HF	Tønsberg
Norway	St Olavs University Hospital	Trondheim
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Linköping University Hiospital	Linköping
Sweden	Karolinska Institute	Stockholm

Sponsors (15)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Drammen sykehus, Haukeland University Hospital, Helse Stavanger HF, Karolinska Institutet, Oslo universitetssykehus HF, Oslo University Hospital, Sahlgrenska University Hospital, Sweden, Sorlandet Hospital HF, St. Olavs Hospital, Sykehuset i Vestfold HF, Sykehuset Innlandet HF, Sykehuset Ostfold, University Hospital, Linkoeping

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking distance	Measured on a tread mill before and after the training period	12 weeks
Primary	Quality of life	Measured with a questionnaire (VASCUQOL-6) before and after the training period	12 weeks