About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Supervised exercise therapy
Other interventionWalking on a treadmill at increasing elevation and pace.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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Slagelse Hospital
Lead sponsor
Region Zealand
Collaborator
Vordingborg Municipality
Collaborator
Kalundborg municipality
Collaborator
Køge Municipality
Collaborator
Næstved municipality
Collaborator
Solrød Municipality
Collaborator