Intermittent ClaudicationNCT01842412
The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
An observational study of Intermittent Claudication, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2013to May 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient clinic, vascular surgery, Trondheim, Norway
Who may be able to join
- A history of any type of uni- or bilateral exertion leg pain.
- A maximal claudication distance that is less than 300 meter
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- An ankle-brachial index between 0.4 and 0.9.
- Lives in Trondheim
Who cannot join
- Diagnosed with critical limb ischemia
- ankle-brachial index > 0.90 or < 0.4
- Limited exercise tolerance
- Warfarin or heparin usage
- Diabetes mellitus
- Underwent a vascular intervention in the last 3 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
The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.
- Conditions
- Intermittent Claudication
- Being tested
- exercise
- Keywords
- Mitochondria, Muscle, Exercise
- 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.
exerciseBehavioural
one bout of exercise training
| Study group | Role | What they receive |
|---|---|---|
| claudication | Not described Receives: Behavioral: exercise | |
| healthy | Not described Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function
respirometry
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMay 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øyvind Ellingsen, prof, Study director, Norwegisn University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842412
- Sponsor's protocol ID
- 2013/395/REK midt
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.
PubMed 27760222
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Initial Effect of Training on Mitochondrial Function in Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01842412
- Acronym / sponsor ID
- 2013/395/REK midt
- Conditions
- Intermittent Claudication
- Keywords
- Mitochondria, Muscle, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Apr 2013 (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 hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| claudication | – | Behavioral: exercise |
| healthy | – | Behavioral: exercise |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic, vascular surgery, Trondheim, Norway
Key inclusion criteria (5 listed)
- A history of any type of uni- or bilateral exertion leg pain.
- A maximal claudication distance that is less than 300 meter
- Diagnosed with intermittent claudication secondary to vascular insufficiency
- An ankle-brachial index between 0.4 and 0.9.
- Lives in Trondheim
Key exclusion criteria (7 listed)
- Diagnosed with critical limb ischemia
- ankle-brachial index > 0.90 or < 0.4
- Limited exercise tolerance
- Warfarin or heparin usage
- Diabetes mellitus
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 |
|---|---|---|
| exerciseone bout of exercise training | Behavioural | claudication, healthy |
Primary outcome
Mitochondrial function
Time frame: One day
respirometry
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 25 Oct 2016.
- Results publication: PubMed 27760222van Schaardenburgh M, Wohlwend M, Rognmo O, Mattsson EJ. Mitochondrial Respiration after One Session of Calf Raise Exercise in Patients with Peripheral Vascular Disease and Healthy Older Adults. PLoS One. 2016 Oct 19;11(10):e0165038. doi: 10.1371/journal.pone.0165038. eCollection 2016.
Related trials for 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
Recruiting
Community-based Exercise Following Revascularization for PAD
Peripheral Artery Disease
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.
Øyvind Ellingsen, prof study director
Norwegisn 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?
An observational study of 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 5 inclusion and 7 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 25 Oct 2016. 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?
Mitochondrial function (time frame: One day). 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 NCT01842412, 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 Oct 2016.