Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark

Not Applicable

Recruiting

• Conditions: Intermittent Claudication
• Interventions: Other: Supervised exercise therapy

• Registration Number: NCT06299956
• Lead Sponsor: Slagelse Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The intervention group	Supervised exercise therapy	Supervised exercise therapy. Walking on a treadmill 3 times a week, for 12 weeks. Supervised by a physiotherapist.

Primary Outcome Measures

Name	Time	Method
Maximal Walking Distance	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 Outcome Measures

Name	Time	Method
Pain-free walking distance	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 onset of claudication pain(2-5 on claudication pain scale) The claudication scale is 1-5. First experienced claudication pain(2-5) is noted in meters.
Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)	Baseline, 12 weeks and 6 months from end of intervention	Patient reported questionnaire: Health-related quality of life. Each question is scored 1-4. When using the VQ6, the sum of each individual question score is used to generate a 'Total' Quality of Life Score (ranging from minimum 6 to maximum 24). A higher value indicates better health status.

Trial Locations

Locations (1)

PROgrez; 🇩🇰 Slagelse, Denmark