Oculopharyngeal Muscular DystrophyNCT02158156
Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
A study testing Exercise in people with Oculopharyngeal Muscular Dystrophy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oculopharyngeal Muscular Dystrophy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Feb 2015
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Danish patients with Oculopharyngeal muscular dystrophy
Who cannot join
- Patients who are too week to train on an cycle-ergometer for 10 weeks
- Patients with other health issues wich confound the interpretation of the efficacy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Neuromuscular Research Unit
Copenhagen, 2100
Vissing, +4535451842
Karen BH Pedersen, Med. student, Bsc
About this study
The investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.
Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.
- Conditions
- Oculopharyngeal Muscular Dystrophy
- Being tested
- Exercise
- Medical subject headings
- Muscular Dystrophy, Oculopharyngeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Excercise | Experimental | 10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on VO2max
Difference in VO2max measured before and after intervention
Measured: 10 weeks
Secondary outcomes (9)
SF-36 Questionaire
Changes in self-rated health from baseline to end of intervention
Measured: 10 weeks
6 minute walk test
Changes in walking distance from baseline to end of intervention
Measured: 10 weeks
Intensity in maximal load (Watt)
Changes in maximal load (watt) in the VO2max-test from baseline to end of intervention.
Measured: 10 weeks
Level of plasma creatine kinase
Marker for exercise-induced muscle damage. Taken week 0,3 and 10.
Measured: 10 weeks
Level of plasma myoglobin
Marker for excercise-induced muscle damage, taken week 0, 3 and 10.
Measured: 10 weeks
6 minute walk test
Changes in walking distance in the test from baseline to end of intervention.
Measured: 10 weeks
A five-time-repetition-sit-to-stand-test
Changes in time of five repetitions from baseline to end of intervention
Measured: 10 weeks
A 14-step-stair-test
Changes in time completing the test from baseline to end of intervention
Measured: 10 weeks
Dynamometry
Changes in external force production from baseline to end of intervention. Dynamometry are measured on hip flexion, dorsal foot flexion, plantar foot flexion, knee flexion, knee extension, and elbow flexion.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oculopharyngeal Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Brorup Heje Pedersen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Karen BH Pedersen, Bsc.med., Principal investigator, Neuromuscular Research Unit, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158156
- Sponsor's protocol ID
- H2-2013-066(A)
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training in Patients With Oculopharyngeal Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT02158156
- Acronym / sponsor ID
- H2-2013-066(A)
- Conditions
- Oculopharyngeal Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 6 Jun 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 investigators want to investigate if patients with Oculopharyngeal Muscular Dystrophy can improve fitness by home-training on a cycle ergometer 30 minute, 3 times a week for 10 weeks.
Participants will be evaluated on maximal oxygen consumption and maximal workload measured by an incremental test at baseline and at the end of the exercise period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excercise | Experimental | Behavioral: Exercise10 weeks of home training on a cycle-ergometer. Exercise 30 minutes every other day or at least three times a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Danish patients with Oculopharyngeal muscular dystrophy
Key exclusion criteria (2 listed)
- Patients who are too week to train on an cycle-ergometer for 10 weeks
- Patients with other health issues wich confound the interpretation of the efficacy.
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 |
|---|---|---|
| ExerciseTen weeks of home-training on a cycle ergometer 3 times a week for 30 minutes. | Behavioural | Excercise |
Primary outcome
Efficacy based on VO2max
Time frame: 10 weeks
Difference in VO2max measured before and after intervention
9 secondary outcomes
SF-36 Questionaire
Time frame: 10 weeks
6 minute walk test
Time frame: 10 weeks
Intensity in maximal load (Watt)
Time frame: 10 weeks
Level of plasma creatine kinase
Time frame: 10 weeks
Level of plasma myoglobin
Time frame: 10 weeks
6 minute walk test
Time frame: 10 weeks
A five-time-repetition-sit-to-stand-test
Time frame: 10 weeks
A 14-step-stair-test
Time frame: 10 weeks
Dynamometry
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
- Website of the Neuromuscular Research Unit, Rigshospitalet, Copenhagen, DenmarkLink provided by the sponsor.
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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.
Karen BH Pedersen, Bsc.med. principal investigator
Neuromuscular Research Unit, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Oculopharyngeal Muscular Dystrophy, run by Copenhagen University Hospital, Rigshospitalet 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on VO2max (time frame: 10 weeks). 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 2014.