ALS Study Determining Various Biomarkers and Strength Comparison After Exercise (ADVANCE)

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Other

Study Status:

Active, currently recruiting

Phase:

Not Applicable

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

Omar Jawdat, MD, University of Kansas Medical Center

Clinicaltrials.gov ID (11 digit #):

NCT03201991

Neals Affiliated?

No

Coordinating Center Contact Information

University of Kansas Medical Center
Laura Herbelin / .(JavaScript must be enabled to view this email address) / 913-588-5095
.(JavaScript must be enabled to view this email address) Kansas City, Kansas 66160 United States

Full Study Summary:

Study Sponsor:

University of Kansas Medical Center

Participant Duration:

12 weeks

Estimated Enrollment:

7

Estimated Study Start Date:

05/01/2017

Estimated Study Completion Date:

05/01/2018

Posting Last Modified Date:

08/02/2017

Date Study Added to alsconsortium.org:

08/02/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    University of Kansas Medical Center
    Laura Herbelin / .(JavaScript must be enabled to view this email address) / 913-588-5095
    Kansas City, Kansas 66160
    United States