RecruitingNot ApplicableNCT06299956

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

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


Sponsor

Slagelse Hospital

Enrollment

600 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.

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Interventions

OTHERSupervised exercise therapy

Walking on a treadmill at increasing elevation and pace.


Locations(1)

PROgrez

Slagelse, Denmark

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NCT06299956


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