ClinicalTrials.gg
RecruitingNCT06299956StRiDEUpdated May 25, 2025

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

An interventional study of Supervised exercise therapy in Intermittent Claudication, sponsored by Slagelse Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Slagelse Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2023, registered Mar 2024).
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intermittent Claudication

Keywords

  • Exercise therapy
  • Smoking cessation
  • Implementation
  • Stakeholders
  • Walking
  • Treadmill
03

In context

Intermittent Claudication

309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.

This study's planned enrollment of 600 is above the median of 74 across 242 interventional studies indexed under Intermittent Claudication.

Browse Intermittent Claudication studies →

Lead sponsor

Slagelse Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Evaluated by a vascular surgeon: patients with e.g. medical issues or comorbidity that enables a participation in SET are not referred.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Other
    The intervention group

    Supervised exercise therapy. Walking on a treadmill 3 times a week, for 12 weeks. Supervised by a physiotherapist.

    Other: Supervised exercise therapy

Interventions

  • OtherSupervised exercise therapy

    Walking on a treadmill at increasing elevation and pace.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jan 2029, 64 months after the start.

Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 64 months is above that.

Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2024
First posted
Mar 8, 2024
StartActual
Sep 1, 2023
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2029
Last update
May 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06299956
Lead sponsor
Slagelse Hospital
Collaborators
Region Zealand, Vordingborg Municipality, Kalundborg municipality, Køge Municipality, Næstved municipality, Solrød Municipality
Responsible party
Sponsor
First posted
Mar 8, 2024
Start date
Sep 1, 2023
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
May 25, 2025

Study contacts

Helle Bøgard
Contact
hboga@regionsjaelland.dk
+4521128969
Lars Tang
Contact
larta@regionsjaelland.dk
Helle Bøgard
principal investigator · Slagelse Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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