Congenital MyotoniaNCT02161835
Relations Between Myotonia and Fitness
A study testing Training in people with Congenital Myotonia, run by Grete Andersen, MD at 1 site in Denmark.
Trial summary
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Congenital Myotonia
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 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
- Diagnosed with either Myotonia congenita or Paramyotonia congenita.
- Patients who have symptoms of myotonia while they are walking stairs.
Who cannot join
- Pregnant or breastfeeding women.
- Physical or mental condition, which prevent participating in the study protocol or which could influence the results.
- Participating in other studies, which could influence the results.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.
Read the detailed description
Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.
The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.
- Conditions
- Congenital Myotonia
- Being tested
- Training
- Keywords
- Congenital myotonia, Myotonia congenita, Thomsons disease, Becker type, Training, Exercise
- Medical subject headings
- Myotonia Congenita, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Participants exercise 3 times a week, 30 minute, on an ergometer bike. Receives: Other: Training |
| Control | No intervention | Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in myotonia
Changes in myotonia is assessed before and after 10 weeks of exercise training. Myotonia is measured as self-assessment of myotonia using the Myotonia Behavior Scale every day in a week before training start and every day in a week before training finish. Furthermore, myotonia is measured as changes in time climbing a 14 steps stair before and after the 10 weeks training period.
Measured: Week 0 and week 10
Secondary outcomes (3)
Changes in fitness
An incremental test is performed at baseline and in the end of 10 weeks training. The primary outcome is change between the two tests in maximal oxygen consumption and work load.
Measured: baseline and after week 10
Changes in creatine Kinase
Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.
Measured: baseline, week 2, week 4, week 7 and week 10
Changes in other myotonia
Myotonia assessed by eye-open-close test, hand open-close test, and by up-and-go test. The three performance tests describe objectively the degree of myotonia.
The outcome measure is changes between before and after training.
Measured: baseline and after week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital MyotoniaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grete Andersen, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grete Andersen, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Grete Andersen, MD, Principal investigator, Neuromuscular research unit Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161835
- Sponsor's protocol ID
- H-4-2014-026
- Status last verified
- May 2015
- First submitted
- 6 Jun 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
- ClinicalTrials.gov ID
- NCT02161835
- Acronym / sponsor ID
- H-4-2014-026
- Conditions
- Congenital Myotonia
- Keywords
- Congenital myotonia, Myotonia congenita, Thomsons disease, Becker type, Training, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Grete Andersen, MDUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 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.
Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.
Detailed description
Investigators aimed to investigate whether a 10-week bicycle exercise program can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia in everyday life. The effect on myotonia is assessed by a standardized myotonia scale with six statements concerning self-rated myotonia, and a number of performance tests that objectively describes the degree of myotonia.
The effect of the training program is assessed by an incremental test, measuring maximal oxygen uptake, maximal heart rate and maximal workload. The muscle enzyme creatine kinase (CK) is measured in plasma to follow muscle injury and safety during the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: TrainingParticipants exercise 3 times a week, 30 minute, on an ergometer bike. |
| Control | No intervention | –Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with either Myotonia congenita or Paramyotonia congenita.
- Patients who have symptoms of myotonia while they are walking stairs.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women.
- Physical or mental condition, which prevent participating in the study protocol or which could influence the results.
- Participating in other studies, which could influence the results.
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 |
|---|---|---|
| Training30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption. | Other | Training |
Primary outcome
Changes in myotonia
Time frame: Week 0 and week 10
Changes in myotonia is assessed before and after 10 weeks of exercise training. Myotonia is measured as self-assessment of myotonia using the Myotonia Behavior Scale every day in a week before training start and every day in a week before training finish. Furthermore, myotonia is measured as changes in time climbing a 14 steps stair before and after the 10 weeks training period.
3 secondary outcomes
Changes in fitness
Time frame: baseline and after week 10
Changes in creatine Kinase
Time frame: baseline, week 2, week 4, week 7 and week 10
Changes in other myotonia
Time frame: baseline and after week 10
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 14 May 2015.
- Neuromuscular research unit Copenhagen homepage.Link 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.
Grete Andersen, MD principal investigator
Neuromuscular research unit Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Congenital Myotonia, run by Grete Andersen, MD 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 3 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 14 May 2015. 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?
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?
Changes in myotonia (time frame: Week 0 and week 10). 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 14 May 2015.