Claudication, Intermittent
Conditions
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.
Interventions
BEHAVIORALPhysical 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
Sponsors
Sykehuset i Vestfold HF
Oslo University Hospital
Haukeland University Hospital
Sorlandet Hospital HF
St. Olavs Hospital
Sykehuset Ostfold
Helse Stavanger HF
Sykehuset Innlandet HF
Drammen sykehus
Alesund Hospital
Sahlgrenska University Hospital
Karolinska Institutet
University Hospital, Linkoeping
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The care provider instructs about the training version. Other people will evaluate the participants before and after the training period
Intervention model description
web-based prospective randomization between two groups of training for patients with Claudicatio intermittens
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway, Sweden
Contacts
Primary ContactErney Mattsson, Professor
Backup ContactJoakim Nordanstig, Professor
Outcome results
None listed