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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSlagelse Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Supervised exercise therapy

    Other intervention

    Walking on a treadmill at increasing elevation and pace.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: The intervention groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 weeks and 6 months from end of intervention

Secondary outcomes

1

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.

Time frame
Baseline, 12 weeks and 6 months from end of intervention
2

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.

Time frame
Baseline, 12 weeks and 6 months from end of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Slagelse Hospital

Lead sponsor

Region Zealand

Collaborator

Vordingborg Municipality

Collaborator

Kalundborg municipality

Collaborator

Køge Municipality

Collaborator

Næstved municipality

Collaborator

Solrød Municipality

Collaborator