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Completed

NCT Number: NCT02161835

Relations Between Myotonia and Fitness

Investigators aimed to investigate whether training can increase fitness levels in patients with myotonia, and thereby reduce the symptom of myotonia.

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Key information

Conditions

Congenital Myotonia Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Motor Activity Muscular Diseases Musculoskeletal Diseases Myotonia Congenita Myotonic Disorders Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training

Other

30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in fitness

    Time frame: baseline and after week 10

    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.

  2. Changes in creatine Kinase

    Time frame: baseline, week 2, week 4, week 7 and week 10

    Creatine Kinase (CK) is measure in plasma to follow muscle injury during the trial.

  3. Changes in other myotonia

    Time frame: baseline and after week 10

    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.

Sponsors and collaborators

Lead sponsor

Grete Andersen, MD

Other

Registry information

Official study title

Relations Between Fitness Status and the Severity of Myotonia in Patients With Congenital Myotonia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2014
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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