Exercise Training Study of Patients With Claudicatio Intermittens

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• walking distance [Срок оценки: 12 weeks]
• Quality of life [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Норвегия · 11 центров

• 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
• … и ещё 3 центра

Швеция · 3 центра

• Sahlgrenska University Hospital — Gothenburg
• Linköping University Hiospital — Linköping
• Karolinska Institute — Stockholm

Идентификаторы

NCT: NCT06448390 · 4/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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