Relations Between Myotonia and Fitness

NCT ID: NCT02161835

Last Updated: 2015-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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

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Congenital Myotonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training

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

Group Type EXPERIMENTAL

Training

Intervention Type OTHER

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

Control

Participants is tested with the 4 objective myotonia test and measurements of self-assessed myotonia by the Myotonia Behavior Scale is collected.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grete Andersen, MD

OTHER

Sponsor Role lead

Responsible Party

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Grete Andersen, MD

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Grete Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Neuromuscular research unit Copenhagen

Locations

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Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://neuromuscular.dk

Neuromuscular research unit Copenhagen homepage.

Other Identifiers

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H-4-2014-026

Identifier Type: -

Identifier Source: org_study_id

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