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Clinical Trials/NCT06299956
NCT06299956
Recruiting
N/A

Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).

Slagelse Hospital1 site in 1 country600 target enrollmentSeptember 1, 2023

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:

  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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
January 2029
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Slagelse Hospital
Responsible Party
Sponsor

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)

Study Sites (1)

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