Clinical trial NCT06448390: Exercise Training Study of Patients With Claudicatio Intermittens
Official title: Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Claudication, Intermittent
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sykehuset i Vestfold HF
name: Oslo University Hospital
name: Haukeland University Hospital
name: Sorlandet Hospital HF
name: St. Olavs Hospital
name: Sykehuset Ostfold
name: Helse Stavanger HF
name: Sykehuset Innlandet HF
name: Drammen sykehus
name: Alesund Hospital
name: Sahlgrenska University Hospital
name: Karolinska Institutet
name: University Hospital, Linkoeping
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: web-based prospective randomization between two groups of training for patients with Claudicatio intermittens
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: walking distance
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken, Drammen sykehus
city: Grålum
country: Norway
facility: Sykehuset Østfold Kalnes
city: Hamar
country: Norway
facility: Sykehuset Innlandet HF
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF Kristiansand
city: Oslo
country: Norway
facility: Ahus University Hospital
city: Oslo
country: Norway
facility: Oslo university Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St Olavs University Hospital
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold HF
city: Ålesund
country: Norway
facility: Ålesund Sykehus
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hiospital
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Sahlgrenska University Hospital
name: Joakim Nordanstig, Professor
role: PRINCIPAL_INVESTIGATOR
References: