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NCT Number: NCT06299956

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

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.

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Key information

Conditions

Intermittent Claudication Behavior Cardiovascular Diseases Health Behavior Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Smoking Cessation Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised exercise therapy

Other

Walking on a treadmill at increasing elevation and pace.

Primary outcomes

  1. Maximal Walking Distance

    Time frame: 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 outcomes

  1. Pain-free walking distance

    Time frame: 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.

  2. Vascular Quality of Life Questionnaire-6 (VASCUQoL-6)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helle Bøgard

CONTACT

[email protected]

+4521128969

Lars Tang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Slagelse Hospital

Other

Collaborators

  • Kalundborg municipality
  • Køge Municipality
  • Næstved municipality
  • Region Zealand
  • Solrød Municipality
  • Vordingborg Municipality

Registry information

Official study title

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

Acronym: StRiDE

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 8, 2024
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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