Intermittent ClaudicationStRiDENCT06299956
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark
A study testing Supervised exercise therapy in people with Intermittent Claudication, run by Slagelse Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Supervised exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lars Tang contact
Denmark1 site, 1 recruiting
- Recruiting
PROgrez
Slagelse, 4700
Helle Bøgard, hboga@regionsjaelland.dk
Lars Tang, larta@reggionsjaelland.dk
About this study
Official title: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
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:
Read more
- 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.
- 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.
- 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.
- Conditions
- Intermittent Claudication
- Being tested
- Supervised exercise therapy
- Keywords
- Exercise therapy, Smoking cessation, Implementation, Stakeholders, Walking, Treadmill
- Medical subject headings
- Intermittent Claudication, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise therapyOther
Walking on a treadmill at increasing elevation and pace.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Other | Supervised exercise therapy. Walking on a treadmill 3 times a week, for 12 weeks. Supervised by a physiotherapist. Receives: Other: Supervised exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks and 6 months from end of intervention
Secondary outcomes (2)
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.
Measured: Baseline, 12 weeks and 6 months from end of intervention
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.
Measured: Baseline, 12 weeks and 6 months from end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Sep 2023
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand, Vordingborg Municipality, Kalundborg municipality, Køge Municipality, Næstved municipality, Solrød Municipality
- Responsible party
- Sponsor
- Investigators
- Helle Bøgard, Principal investigator, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299956
- Sponsor's protocol ID
- 2023-SFHHB-IC-001
- Acronym
- StRiDE
- Status last verified
- May 2025
- First submitted
- 1 Mar 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39804879
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercise-based Rehabilitation for People With Intermittent Claudication - Study Protocol for a Danish Implementation Process (StRiDE).
- ClinicalTrials.gov ID
- NCT06299956
- Acronym / sponsor ID
- StRiDE / 2023-SFHHB-IC-001
- Conditions
- Intermittent Claudication
- Keywords
- Exercise therapy, Smoking cessation, Implementation, Stakeholders, Walking, Treadmill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Region Zealand, Vordingborg Municipality, Kalundborg municipality, Køge Municipality, Næstved municipality, Solrød Municipality
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Other | Other: Supervised exercise therapySupervised exercise therapy. Walking on a treadmill 3 times a week, for 12 weeks. Supervised by a physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise therapyWalking on a treadmill at increasing elevation and pace. | Other | The intervention group |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 39804879Hajdu 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.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Tang contact
Helle Bøgard principal investigator
Slagelse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise therapy in people with Intermittent Claudication, run by Slagelse Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helle Bøgard (+4521128969, hboga@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Walking Distance (time frame: Baseline, 12 weeks and 6 months from end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.