Image

Exercise Training Study of Patients With Claudicatio Intermittens

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

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.

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.

Eligibility

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

Study details

Claudication, Intermittent

NCT06448390

Norwegian University of Science and Technology

15 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.