Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT06299956
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
Sponsor:
Slagelse Hospital
Organization:
Study Overview
Official Title:
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
StRiDE
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: