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Recruiting Not applicable

Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark

NCT06299956 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2023-09-01
Last updated
2025-05-25

Condition(s) studied

Intermittent Claudication

Investigational drug(s) / intervention(s)

Supervised exercise therapy

Supervised exercise therapy: Walking on a treadmill at increasing elevation and pace.

Study summary

The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.

The objective of this project is to describe:

1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
3. Outcomes available for assessment of benefits and harms from the SET intervention.

Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest. * Distal blood pressure with an ankle-brachial index (ABI) \> 50 mmHg for non-diabetics or toe brachial index (TBI) \> 40 mmHg for diabetics. Exclusion criteria: • Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.

Primary outcome measure(s)

  • Maximal Walking Distance — Baseline, 12 weeks and 6 months from end of intervention
    Treadmill test 3.2 km/h and 0% inclination for 2 min. Then the inclination will incline 2% every 2 min until the patient cannot walk further. The distance is noted in meters.

Trial sites (1)

FacilityCityRegionStatus
PROgrez Slagelse Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06299956 on ClinicalTrials.gov ↗ ← All trials in Denmark