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Recruiting NCT06448390

Exercise Training Study of Patients With Claudicatio Intermittens

No phase Interventional Claudication, Intermittent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical training.
Who it may be relevant to
Registry conditions: Claudication, Intermittent. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • walking distance [Time frame: 12 weeks]
  • Quality of life [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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
  • Using statins and antiplatelet drugs since at least 3 months
  • age> 18 years
  • Signed consent

Exclusion criteria

  • 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
  • symptoms less than 6 months
  • Diabetes measured with HbA1c being over 48 mmol/mol (6%)
  • Revascularisation the last 6 months
  • Pain in the calves after longer than 300 m measured on a treadmill
  • Reduced mobility in the ankles
  • Reduced physical ability to perform a test on a treadmill.
  • Age less than 18 years
  • General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
  • No Signed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Supportive care

Study locations

Norway · 11 centers
  • Ålesund Sykehus — Ålesund
  • Haukeland University Hospital — Bergen
  • Vestre Viken, Drammen sykehus — Drammen
  • Sykehuset Østfold Kalnes — Grålum
  • Sykehuset Innlandet HF — Hamar
  • Sørlandet Sykehus HF Kristiansand — Kristiansand
  • Ahus University Hospital — Oslo
  • Oslo university Hospital — Oslo
  • … and 3 more centers
Sweden · 3 centers
  • Sahlgrenska University Hospital — Gothenburg
  • Linköping University Hiospital — Linköping
  • Karolinska Institute — Stockholm

Identifiers

NCT: NCT06448390 · 4/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗