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

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.

NCT Number	NCT06299956
Lead Sponsor	Slagelse Hospital Collaborators: Region Zealand, Vordingborg Municipality, Kalundborg municipality, Køge Municipality, Næstved municipality, Solrød Municipality
Conditions	Intermittent Claudication
Enrollment	600 participants
Start Date	2023-09-01
Primary Completion	2029-01 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-25