Relations Between Myotonia and Fitness

NCT02161835 | Completed

• 1 other identifier: H-4-2014-026
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Myotonia

Keywords

Congenital myotonia; Myotonia congenita; Thomsons disease; Becker type; Training; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0 and week 10

Secondary Outcomes (3)

• Changes in fitness

  baseline and after week 10

• Changes in creatine Kinase

  baseline, week 2, week 4, week 7 and week 10

• Changes in other myotonia

  baseline and after week 10

Study Arms (2)

Training

EXPERIMENTAL

Participants exercise 3 times a week, 30 minute, on an ergometer bike.

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.

Interventions

Training OTHER

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

Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with either Myotonia congenita or Paramyotonia congenita.
• Patients who have symptoms of myotonia while they are walking stairs.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grete Andersen, MD: lead

Study Sites (1)

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Links

• Neuromuscular research unit Copenhagen homepage.

MeSH Terms

Conditions

Myotonia Congenita; Motor Activity

Condition Hierarchy (Ancestors)

Myotonic Disorders; Muscular Diseases; Musculoskeletal Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Grete Andersen, MD

  Neuromuscular research unit Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 12, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

DK (1)