Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients

NCT03900585 | Withdrawn

• 1 other identifier: H-18031231
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week. Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (1)

• 6 minutes walk test

  Walk test

  6 minutes

Secondary Outcomes (6)

• 30-s sit to stand test

  30 seconds

• Quantitative Myasthenia Gravis Score

  45 minutes

• Myasthenia gravis composite score

  30 minutes

• Myasthenia gravis activity of daily living profile (MG-ADL)

  10 minutes

• Myasthenia gravis quality of life 15-item score (MG-QoL15)

  3 minutes

Study Arms (2)

Interval walking

EXPERIMENTAL

Interval walking for 10 weeks, 150 minutes per week administered by an app on the patient's telephone.

Behavioral: Interval walking

Control

NO INTERVENTION

Patients live as normal, though aerobe training restricted to a maximum of 30 minutes a week.

Interventions

Interval walking BEHAVIORAL

Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.

Interval walking

Eligibility Criteria

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

You may qualify if:

• Able to provide signed informed consent.
• Able to read and understand Danish or English.
• Diagnosed with 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 EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.

You may not qualify if:

• MGFA grade V disease
• Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
• 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

MeSH Terms

Conditions

Myasthenia Gravis

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

Study Officials

• John Vissing, Professor

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Health Science, PhD student

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: April 3, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03