Claudication, IntermittentNCT06448390
Exercise Training Study of Patients With Claudicatio Intermittens
A study testing Physical training in people with Claudication, Intermittent, run by Norwegian University of Science and Technology at 14 sites in 2 countries.
Trial summary
The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Claudication, Intermittent
- What is being tested?
- Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 1 Jan 2024to 31 Dec 2025
- 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
- Pain in the calves after 300 m, or less measured on a treadmill
- Stable symptoms last 6 months or more
- The pain must be gone within 5 minutes after the patients stop walking
- Ankle-Brachial index at 0.7 or lower at rest
- Using statins and antiplatelet drugs since at least 3 months
- age> 18 years
- Signed consent
Who cannot join
- pain in the hips or elsewhere outside the calves while walking
- Remaining pain more than 5 minutes after stopped walking.
- Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
- Use of statins and antiplatelet drugs less than 3 months
- symptoms less than 6 months
- Diabetes measured with HbA1c being over 48 mmol/mol (6%)
Show all 13Show fewer
- Revascularisation the last 6 months
- Pain in the calves after longer than 300 m measured on a treadmill
- Reduced mobility in the ankles
- Reduced physical ability to perform a test on a treadmill.
- Age less than 18 years
- General conditions that impairs the ability to take part in a training study including Obesity, KOLS, heart disease, arthrosis, inflammatory joint diseases .
- No Signed consent
Trial locations and contacts
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
Norway11 sites, 11 recruiting
- Recruiting
Ålesund Sykehus
Ålesund
Torstein Fjørtoft, MD, Torstein.fj@gmail.com
- Recruiting
Haukeland University Hospital
Bergen
Antje Butter, MD, +4740537892, antje.butter@helse-bergen.no
Antje Butter, antje.butter@helse-bergen.no
- Recruiting
Vestre Viken, Drammen sykehus
Drammen
Øyvind Werpen Skoe, MD, Oyvind.skoe@gmail.com
Silje Thronæs
- Recruiting
Sykehuset Østfold Kalnes
Grålum
Thore Borgenvik, MD, Thore.Langfeldt.Borgenvik@so-hf.no
- Recruiting
Sykehuset Innlandet HF
Hamar
Thomas Spansdahl, MD, thomas.spansdahl@sykehuset-innlandet.no
- Recruiting
Sørlandet Sykehus HF Kristiansand
Kristiansand
Erik Mulder Pettersen, MD, Erik.Mulder.Pettersen@sshf.no
Marie Tryland Høiberg, nurse
- Recruiting
Ahus University Hospital
Oslo
Jon Tryggve Ask-Nessa, MD, Jon.Tryggve.Ask-Nessa@ahus.no
MD
- Recruiting
Oslo university Hospital
Oslo
Toril Rabben, MD, torabb@ous-hf.no
- Recruiting
Stavanger University Hospital
Stavanger
Joar Reutz Nøttveit, MD, jorz@sus.no
Tore Galdal
- Recruiting
Sykehuset i Vestfold HF
Tønsberg
Torbjørn Bakken, MD, +4733 34 20 00, torbjorn.bakken@siv.no
Torbjørn Bakken, MD
- Recruiting
St Olavs University Hospital
Trondheim
Magne Torsteinsen, MD, Magne.Torsteinsen@stolav.no
Cathrine Kjemperud, nurse
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Joakim Nordanstig, MD, joakim.nordanstig@vgregion.se
Monica Broeren, nurse
- Recruiting
Linköping University Hiospital
Linköping
Håkan Persson, MD, hakan.parsson@liu.se
Sofie Aronsson, MD, Sofie.Aronsson@regionostergotland.se
- Recruiting
Karolinska Institute
Stockholm
Rebecka Hultgren, rebecka.hultgren@ki.se
Olga Nilsson, Nurse
About this study
Official title: Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
The aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking.
Read the detailed description
Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.
The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.
- Conditions
- Claudication, Intermittent
- Being tested
- Physical training
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
The patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session
| Study group | Role | What they receive |
|---|---|---|
| Five plus training | Active comparator | During "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect. Receives: Behavioral: Physical training |
| walking | Active comparator | Walking at least 30 minutes three times per week. Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking distance
Measured on a tread mill before and after the training period
Measured: 12 weeks
Quality of life
Measured with a questionnaire (VASCUQOL-6) before and after the training period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Claudication, IntermittentStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- web-based prospective randomization between two groups of training for patients with Claudicatio intermittens
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset i Vestfold HF, Oslo University Hospital, Haukeland University Hospital, Sorlandet Hospital HF, St. Olavs Hospital, Sykehuset Ostfold, Helse Stavanger HF, Sykehuset Innlandet HF, Drammen sykehus, Alesund Hospital, Sahlgrenska University Hospital, Karolinska Institutet, University Hospital, Linkoeping
- Responsible party
- Sponsor
- Investigators
- Joakim Nordanstig, Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448390
- Sponsor's protocol ID
- 4/2024
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the ethical permission no individual data can be shared or identified. The participant can be fully informed if that is requested
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
- ClinicalTrials.gov ID
- NCT06448390
- Acronym / sponsor ID
- 4/2024
- Conditions
- Claudication, Intermittent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Sykehuset i Vestfold HF, Oslo University Hospital, Haukeland University Hospital, Sorlandet Hospital HF, St. Olavs Hospital, Sykehuset Ostfold, Helse Stavanger HF, Sykehuset Innlandet HF, Drammen sykehus, Alesund Hospital, Sahlgrenska University Hospital, Karolinska Institutet, University Hospital, Linkoeping
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jun 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 aim of the study is to evaluate whether walking capacity in patients with intermittent claudication is improved more by home-based 5+ exercise training than by current recommendations of daily walking.
Detailed description
Patients with intermittent claudication will by a web-based program be randomized to either "five plus training" or walking at least 30 minutes three times per week. During the "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect.
The patients are followed by absolute walking distance on a treadmill, quality of life questionnaire, and Ankle-brachial index.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- web-based prospective randomization between two groups of training for patients with Claudicatio intermittens
| Arm | Type | Receives |
|---|---|---|
| Five plus training | Active comparator | Behavioral: Physical trainingDuring "five plus training" the participants are standing in front of a wall, which is used for support of the balance. The body is lifted with the calf musculature to the maximal height that the subject can achieve. This is repeated until pain is felt in the calf musculature. Following the initiation of pain the subject performs five extra repetitions. The five extra calf raises are included to secure induction of ischemia followed by reperfusion to secure maximal training effect. |
| walking | Active comparator | Behavioral: Physical trainingWalking at least 30 minutes three times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pain in the calves after 300 m, or less measured on a treadmill
- Stable symptoms last 6 months or more
- The pain must be gone within 5 minutes after the patients stop walking
- Ankle-Brachial index at 0.7 or lower at rest
- Using statins and antiplatelet drugs since at least 3 months
Key exclusion criteria (13 listed)
- pain in the hips or elsewhere outside the calves while walking
- Remaining pain more than 5 minutes after stopped walking.
- Impossible to compress the arteries while measruing ABI or ABI lower than 0.4
- Use of statins and antiplatelet drugs less than 3 months
- symptoms less than 6 months
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 |
|---|---|---|
| Physical trainingThe patients are randomized to either walking 30 minutes 3 times a week or lifting the body to a tip toe position three times a day until pain in the claves and then add another five liftings before ending the session | Behavioural | Five plus training, walking |
Primary outcome
walking distance
Time frame: 12 weeks
Measured on a tread mill before and after the training period
Quality of life
Time frame: 12 weeks
Measured with a questionnaire (VASCUQOL-6) before and after the training period
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 6 Jun 2025.
- Individual participant dataSharing planned: No. According to the ethical permission no individual data can be shared or identified. The participant can be fully informed if that is requested
Related trials for Claudication, Intermittent
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
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
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Joakim Nordanstig, Professor principal investigator
Sahlgrenska University Hospital
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Claudication, Intermittent, run by Norwegian University of Science and Technology at 14 sites in 2 countries.
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 7 inclusion and 13 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 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Norway, Sweden. 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 Erney Mattsson, Professor (0046737854490, erney.mattsson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking distance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.