Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised exercise therapy.
- Who it may be relevant to
- Registry conditions: Intermittent Claudication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
Overview
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
- Other Supervised exercise therapy
Walking on a treadmill at increasing elevation and pace.
Primary outcome measures
- Maximal Walking Distance [Time frame: Baseline, 12 weeks and 6 months from end of intervention]
Secondary outcome measures (2)
- Pain-free walking distance [Time frame: Baseline, 12 weeks and 6 months from end of intervention]
- Vascular Quality of Life Questionnaire-6 (VASCUQoL-6) [Time frame: Baseline, 12 weeks and 6 months from end of intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- PROgrez — Slagelse
Publications
- Hajdu SF, Bogard H, Aagaard TV, Roikjaer SG, Simony C, Dalhoff A, Houlind K, Luijk A, Ulriksen I, Jensen LT, Skou ST, Tang LH. Supervised exercise-based rehabilitation for people with intermittent claudication-Study protocol for a Danish implementation process (StRiDE). PLoS One. 2025 Jan 13;20(1):e0315577. doi: 10.1371/journal.pone.0315577. eCollection 2025. PMID 39804879
Identifiers
NCT: NCT06299956 · 2023-SFHHB-IC-001