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

Intermittent Claudication Clinical Trial

— StRiDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299956
• Other study ID #: 2023-SFHHB-IC-001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 2029

Study information

• Verified date: March 2024
• Source: Slagelse Hospital
• Contact: Helle Bøgard
• Phone: +4521128969
• Email: hboga[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Other:
• Supervised exercise therapy
Walking on a treadmill at increasing elevation and pace.

Locations

Country	Name	City	State
Denmark	PROgrez	Slagelse

Sponsors (7)

Lead Sponsor	Collaborator
Slagelse Hospital	Kalundborg municipality, Køge Municipality, Næstved municipality, Region Zealand, Solrød Municipality, Vordingborg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Walking Distance	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.	Baseline, 12 weeks and 6 months from end of intervention
Secondary	Pain-free walking distance	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.	Baseline, 12 weeks and 6 months from end of intervention
Secondary	Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)	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.	Baseline, 12 weeks and 6 months from end of intervention