Exercise therapy for people with leg pain from poor circulation in Denmark
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
This study is testing a supervised exercise program combined with quitting smoking to see if it helps adults in Denmark with leg pain from poor circulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Slagelse Hospital Academic / other |
| Locations | 1 site (Slagelse) |
| Trial ID | NCT06299956 on ClinicalTrials.gov |
What this trial studies
This project aims to implement a supervised exercise therapy program combined with smoking cessation for adults suffering from intermittent claudication in Region Zealand, Denmark. Participants will engage in treadmill walking sessions three times a week for 12 weeks, with a focus on monitoring the implementation process and outcomes. The study will assess the effectiveness of the intervention through quality monitoring and feedback collection over a six-month follow-up period after the exercise therapy is completed.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing leg pain due to intermittent claudication related to arteriosclerosis.
Not a fit: Patients with contraindications or comorbidities that prevent participation in supervised exercise therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and quality of life for patients with intermittent claudication.
How similar studies have performed: Other studies have shown positive outcomes with supervised exercise therapy for intermittent claudication, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Slagelse
- PROgrez — Slagelse, Denmark (Recruiting)
Study contacts
- Principal investigator: Helle Bøgard — Slagelse Hospital
- Study coordinator: Helle Bøgard
- Email: hboga@regionsjaelland.dk
- Phone: +4521128969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.