ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this study is to determine the muscle strength of a muscle in the thigh after 12 weeks of home exercise.

Key facts

Study ID

NCT03201991

Run by

University of Kansas Medical Center

People needed

9

Starts

2017-05-01

Expected to finish

2018-04-18

Last updated by the study team

2019-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of possible, probable or definite amyotrophic lateral sclerosis (ALS) based on the revised El-Escorial criteria
• Presence in ipsilateral leg of either weakness in any muscle group or of active denervation by needle electromyography (EMG) which is a surrogate marker of early denervation
• Ipsilateral quadriceps femoris strength: >=4
• Ambulatory with or without assistance
• Revised ALS Functional Rating Scale (ALSFRS-R) Score > 30
• Forced expiratory vital capacity (FVC) >50% of predicted

You may not qualify if…

• ALSFRS-R ≤ 30
• Quadriceps femoris strength <4
• Unable to walk or uses wheelchair as primary means of mobility
• More than mild atrophy of quadriceps
• Bleeding disorder or uptake of anticoagulants
• Unwilling to comply with exercise and needle muscle biopsy
• Not a good research candidate according to the medical opinion of investigator

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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