Exercise Training Study of Patients With Claudicatio Intermittens

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorwegian University of Science and Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pain in the calves after 300 m, or less measured on a treadmill

Stable symptoms last 6 months or more

The pain must be gone within 5 minutes after the patients stop walking

Ankle-Brachial index at 0.7 or lower at rest

Disqualifiers

pain in the hips or elsewhere outside the calves while walking

Remaining pain more than 5 minutes after stopped walking.

Impossible to compress the arteries while measruing ABI or ABI lower than 0.4

Use of statins and antiplatelet drugs less than 3 months

Trial design

Design model

Single group

Treatments tested in this trial

  • Physical training

    Behavioral

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Five plus trainingActive comparator 1 intervention
Group B: walkingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

walking distance

Measured on a tread mill before and after the training period

Time frame
12 weeks
2

Quality of life

Measured with a questionnaire (VASCUQOL-6) before and after the training period

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norwegian University of Science and Technology

Lead sponsor

Sykehuset i Vestfold HF

Collaborator

Oslo University Hospital

Collaborator

Haukeland University Hospital

Collaborator

Sorlandet Hospital HF

Collaborator

St. Olavs Hospital

Collaborator

Sykehuset Ostfold

Collaborator

Helse Stavanger HF

Collaborator

Sykehuset Innlandet HF

Collaborator

Drammen sykehus

Collaborator

Alesund Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska Institutet

Collaborator

University Hospital, Linkoeping

Collaborator