NCT06299956 Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
| NCT ID | NCT06299956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Slagelse Hospital |
| Condition | Intermittent Claudication |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2023-09-01 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Helle Bøgard
PRINCIPAL INVESTIGATOR
Slagelse Hospital
Frequently Asked Questions
Who can join the NCT06299956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intermittent Claudication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06299956 currently recruiting?
Yes, NCT06299956 is actively recruiting participants. Contact the research team at hboga@regionsjaelland.dk for enrollment information.
Where is the NCT06299956 trial being conducted?
This trial is being conducted at Slagelse, Denmark.
Who is sponsoring the NCT06299956 clinical trial?
NCT06299956 is sponsored by Slagelse Hospital. The principal investigator is Helle Bøgard at Slagelse Hospital. The trial plans to enroll 600 participants.