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NCT Number: NCT06448390

Exercise Training Study of Patients With Claudicatio Intermittens

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. walking distance

    Time frame: 12 weeks

    Measured on a tread mill before and after the training period

  2. Quality of life

    Time frame: 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erney Mattsson, Professor

CONTACT

[email protected]

0046737854490

Joakim Nordanstig, Professor

CONTACT

[email protected]

+46708259496

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Alesund Hospital
  • Drammen sykehus
  • Haukeland University Hospital
  • Helse Stavanger HF
  • Karolinska Institutet
  • Oslo University Hospital
  • Sahlgrenska University Hospital
  • Sorlandet Hospital HF
  • St. Olavs Hospital
  • Sykehuset Innlandet HF
  • Sykehuset Ostfold
  • Sykehuset i Vestfold HF
  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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