Back to resultsRelations Between Myotonia and Fitness
Primary Purpose
Congenital Myotonia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Myotonia focused on measuring Congenital myotonia, Myotonia congenita, Thomsons disease, Becker type, Training, Exercise
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with either Myotonia congenita or Paramyotonia congenita.
- Patients who have symptoms of myotonia while they are walking stairs.
Exclusion Criteria:
- 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.
Sites / Locations
- Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training
Control
Arm Description
Participants exercise 3 times a week, 30 minute, on an ergometer bike.
Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Changes in creatine Kinase
Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161835
Brief Title
Relations Between Myotonia and Fitness
Official Title
Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grete Andersen, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Myotonia
Keywords
Congenital myotonia, Myotonia congenita, Thomsons disease, Becker type, Training, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
Participants exercise 3 times a week, 30 minute, on an ergometer bike.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected.
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.
Primary Outcome Measure Information:
Title
Changes in myotonia
Description
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.
Time Frame
Week 0 and week 10
Secondary Outcome Measure Information:
Title
Changes in fitness
Description
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.
Time Frame
baseline and after week 10
Title
Changes in creatine Kinase
Description
Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.
Time Frame
baseline, week 2, week 4, week 7 and week 10
Title
Changes in other myotonia
Description
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.
Time Frame
baseline and after week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with either Myotonia congenita or Paramyotonia congenita.
Patients who have symptoms of myotonia while they are walking stairs.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grete Andersen, MD
Organizational Affiliation
Neuromuscular research unit Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://neuromuscular.dk
Description
Neuromuscular research unit Copenhagen homepage.
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Relations Between Myotonia and Fitness
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