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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06299956
Other study ID # 2023-SFHHB-IC-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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