ALS Study Determining Various Biomarkers and Strength Comparison After Exercise

Study Purpose:

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

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

Resistance Exercise Program




Study Chair(s)/Principal Investigator(s):

Omar Jawdat, MD, University of Kansas Medical Center ID:


Neals Affiliated?


Coordinating Center Contact Information

University of Kansas Medical Center

Kansas City, Kansas, 66160 United States

Full Study Summary:

Study participation lasts a total of three months and includes two study visits. Subjects are asked to undergo strength testing, physical exams, lab draws, and muscle biopsies at each study visit. Muscle biopsies are done in the quadriceps muscle. In between study visits, subjects are asked to maintain a weekly exercise regimen given to them by the study physical therapist.

Study Sponsor:

University of Kansas Medical Center

Participant Duration:

12 weeks

Estimated Enrollment:


Estimated Study Start Date:

05 / 01 / 2017

Estimated Study Completion Date:

04 / 18 / 2018

Posting Last Modified Date:

12 / 19 / 2019

Date Study Added to

06 / 28 / 2017

Minimum Age:

18 Years

Maximum Age:


Can participants use Riluzole?


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

University of Kansas Medical Center

Kansas City, Kansas 66160
United States