Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intermittent Claudication
- Sponsor
- Slagelse Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Maximal Walking Distance
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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:
- 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.
- 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.
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximal Walking Distance
Time Frame: 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.
Secondary Outcomes
- Pain-free walking distance(Baseline, 12 weeks and 6 months from end of intervention)
- Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)(Baseline, 12 weeks and 6 months from end of intervention)