Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test

NCT03905161 | Completed

• 1 other identifier: H-18031231 3
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Myasthenia Gravis

Keywords

Fatigue; 6-minute walk test; Rhythmic Auditory Stimulation

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test (6MWT)

  The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test.

  6 minutes

Secondary Outcomes (3)

• Heart rate

  5 minutes

• The Borg Rating of Perceived Exertion (RPE) scale.

  2 minutes

• Myasthenia gravis composite score (MGC)

  30 minutes

Study Arms (1)

Myasthenia patients

Danish patients with myasthenia gravis seen at the Department of Neurology, Rigshospitalet

Other: 6-minute walk test

Interventions

6-minute walk test OTHER

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 for neuromuscular patients.

Myasthenia patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MG seen in the Department of Neurology, Rigshospitalet, fulfilling the inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Myasthenia Gravis; Fatigue

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda K Andersen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiotherapist, PhD student

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: February 10, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

DK (1)