Intermittent ClaudicationNCT02310256
A Clinical Trial on the Effects of Home-based Five Plus Exercise Training
A study testing Five plus exercise training in people with Intermittent Claudication, run by Norwegian University of Science and Technology at 1 site in Norway.
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 50 to 80 years
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Five plus exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- An ankle-brachial index between 0.4 and 0.9.
Who cannot join
- Diagnosed with critical limb ischemia
- Ankle-brachial index (ABI) > 0.90 or < 0.4
- Limited exercise tolerance
- Warfarin or heparin usage
- Underwent a vascular intervention in the last 6 months
- Active cancer, renal- or liver disease
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department for circulation and medical imaging, NTNU
Trondheim, Postboks 8905, 7491
About this study
Official title: A 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. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.
- Conditions
- Intermittent Claudication
- Being tested
- Five plus exercise training
- Keywords
- Mitochondria, muscle, Exercise, Blood Flow Velocity
- Medical subject headings
- Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five plus exercise trainingOther
calf raise exercise
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Five Plus | Active comparator | Exercise training Receives: Other: Five plus exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute walking distance (meters) as measured by 6 minute walking test
treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
Measured: 8 weeks
mitochondrial function measured by respirometry
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
Measured: 8 weeks
Secondary outcomes (3)
Arterial bloodflow measured by plethysmography
measured by plethysmography
Measured: 8 weeks
Quality of life assessed by SF 36 and CLAU-S questionnaires
assessed by SF 36 and CLAU-S questionnaires
Measured: 8 weeks
Peak oxygen uptake measured by cardio-pulmonal exercise testing
measured by cardio-pulmonal exercise testing
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Øivind Rognmo, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310256
- Sponsor's protocol ID
- 2011/2533/REK midt
- Status last verified
- Mar 2018
- First submitted
- 10 Nov 2014
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9.
PubMed 28285932van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6.
PubMed 28592294
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Effects of Home-based Five Plus Exercise Training
- ClinicalTrials.gov ID
- NCT02310256
- Acronym / sponsor ID
- 2011/2533/REK midt
- Conditions
- Intermittent Claudication
- Keywords
- Mitochondria, muscle, Exercise, Blood Flow Velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Dec 2014 (estimated)
- 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. The study will elucidate if such a potential effect is dependent on changes in mitochondrial respiratory capacity, blood flow or both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Five Plus | Active comparator | Other: Five plus exercise trainingExercise training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- An ankle-brachial index between 0.4 and 0.9.
Key exclusion criteria (6 listed)
- Diagnosed with critical limb ischemia
- Ankle-brachial index (ABI) > 0.90 or < 0.4
- Limited exercise tolerance
- Warfarin or heparin usage
- Underwent a vascular intervention in the last 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 |
|---|---|---|
| Five plus exercise trainingcalf raise exercise | Other | Five Plus |
Primary outcome
absolute walking distance (meters) as measured by 6 minute walking test
Time frame: 8 weeks
treadmill 3.2 km/hour and inclination increase every 2 minute combined with 6 minute walking test
mitochondrial function measured by respirometry
Time frame: 8 weeks
Oxygen consumption (pmol O2 per second per mg of wet weight tissue) measured by respirometry
3 secondary outcomes
Arterial bloodflow measured by plethysmography
Time frame: 8 weeks
Quality of life assessed by SF 36 and CLAU-S questionnaires
Time frame: 8 weeks
Peak oxygen uptake measured by cardio-pulmonal exercise testing
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Results publication: PubMed 28285932Van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson E. Calf raise exercise increases walking performance in patients with intermittent claudication. J Vasc Surg. 2017 May;65(5):1473-1482. doi: 10.1016/j.jvs.2016.12.106. Epub 2017 Mar 9.
- Results publication: PubMed 28592294van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJR. Exercise in claudicants increase or decrease walking ability and the response relates to mitochondrial function. J Transl Med. 2017 Jun 7;15(1):130. doi: 10.1186/s12967-017-1232-6.
Related trials for Intermittent Claudication
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. This study is not recruiting at the moment.
Øivind Rognmo, phd study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five plus exercise training in people with Intermittent Claudication, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 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: finished, as of the sponsor's last update on 30 Mar 2018. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absolute walking distance (meters) as measured by 6 minute walking test (time frame: 8 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?
On the ClinicalTrials.gov record for NCT02310256, which also lists 2 linked publications.
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 30 Mar 2018.