Intermittent Claudication
Conditions
Keywords
Exercise therapy, Smoking cessation, Implementation, Stakeholders, Walking, Treadmill
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.
Interventions
Walking on a treadmill at increasing elevation and pace.
Sponsors
Region Zealand
Vordingborg Municipality
Kalundborg municipality
Køge Municipality
Næstved municipality
Solrød Municipality
Slagelse Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Contacts
Primary ContactHelle Bøgard
Backup ContactLars Tang
Outcome results
None listed