Clinical trial NCT03905161: Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test
Official title: Does Rhythmic Auditory Stimulation Influence Walking Speed in the 6-minute Walk Test in Patients With Myasthenia Gravis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: Fatigue
6-minute walk test
Rhythmic Auditory Stimulation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MG seen in the Department of Neurology, Rigshospitalet, fulfilling the inclusion criteria.

Brief summary: The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis (MG).

Detailed description: Background

1. The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed.
2. Rhythmic auditory stimulation has repeatedly been shown to improve gait parameters in individuals with neurologic impairment.

The aim of this study is to investigate if rhythmic auditory stimulation can influence walking speed, during a 6MWT in patients with myasthenia gravis.

Patients with MG are asked to complete two 6MWTs separated by minimum 30 minutes of rest. Before the 6MWTs patient is instructed to walk 60 m as fast as possible, and their steps per minute (SPM) is recorded. When completing the 6MWTs, one of the tests is accompanied by music (m6MWT) with a beat per minute (BPM) corresponding to patients' SPM. The order of the 6MWTs is randomly decided by pre-ordered sealed envelopes.

Eligibility criteria: Inclusion Criteria:

* Able to provide signed informed consent.
* Able to read and understand Danish or English.
* Diagnosis of mild to moderate MG (Able to provide signed informed consent.

  * Able to read and understand Danish or English.
  * Diagnosed with generalized mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
  * Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement \> 10%) on electromyography (EMG) or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acetylcholinesterase inhibitors.
* Ability to walk \> 60 meters in a 6MWT.

Exclusion Criteria:

MGFA grade V disease

* Other disorders that are not related to MG, or drugs, that interfere with muscle strength, walking ability, balance and fatigue (e.g. heart failure).
* Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
* Dementia or pregnancy.
* Unspecified reasons judged by the investigator

Primary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: 6 minutes
Secondary outcomes:
measure: Heart rate
timeFrame: 5 minutes
measure: The Borg Rating of Perceived Exertion (RPE) scale.
timeFrame: 2 minutes
measure: Myasthenia gravis composite score (MGC)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Linda K Andersen
role: PRINCIPAL_INVESTIGATOR
References: