Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

In this study the investigators will ask participants with ALS to exercise in one of three ways: weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of motion exercise (the current

Disease:

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

Study Type:

Interventional Trial

Study Category:

Exercise

Study Status:

Not enrolling

Phase:

Not Applicable

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

Nicholas Maragakis, MD, (Johns Hopkins University)

Clinicaltrials.gov ID (11 digit #):

NCT01521728

Neals Affiliated?

Yes

Coordinating Center Contact Information

Johns Hopkins University
Lora L Clawson, CRNP / .(JavaScript must be enabled to view this email address) / 4109558511
.(JavaScript must be enabled to view this email address) Baltimore, Maryland 21287 United States

Full Study Summary:

The first questions asked by patients with a new diagnosis of Amyotrophic Lateral Sclerosis (ALS) often include: "Does exercise help slow the progression of the disease?", "Is there any harm in exercising?", or "What type of exercise (endurance or resistance) is most appropriate?" At this time, however, there is a lack of answers for people who suffer from an illness that affects their strength above all else. Yet the beneficial effects of exercise in both healthy people as well as people with other diseases have been extensively studied and resulted in recommendations about the types of exercise that are beneficial. In this study the investigators will ask participants with ALS to exercise in one of three ways: weightlifting (resistance exercise), stationary bicycling (endurance exercise), and range of motion exercise (the current "standard of care" for ALS patients). The investigators will use several different types of tests to determine whether one type of exercise is tolerated better and is safer than another. The investigators will also collect information about how the body responds to exercise in ALS. This study will help in the development of a larger national study to understand how exercise can be combined with other treatments to potentially improve strength and alter the course of the disease.

Study Sponsor:

Johns Hopkins University

Participant Duration:

6 months

Estimated Enrollment:

60

Estimated Study Start Date:

12/31/2011

Estimated Study Completion Date:

02/29/2016

Posting Last Modified Date:

01/10/2018

Date Study Added to alsconsortium.org:

01/30/2012
  • More Information

    On April 3, 2018, Drs. Gabrielle Steinhorn and Nicholas J. Maragakis from Johns Hopkins University led a webinar on the results of the recently completed Trial of Resistance and Endurance Exercise in ALS. Click here to watch a recording of the webinar.

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Min Vital Capacity (% predicted normal):

    70

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Participants with familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the WFN El Escorial criteria
    Participants who are ages 18-80, inclusive.
    Slow Vital Capacity (SVC) must be equal to or greater than 70% of predicted value
    ALSFRS-R score >30.
    Patients who are currently on any medications must be on a stable dose for the past 30 days.
    Participants must provide informed consent prior to completion of any study procedures.

    Exclusion Criteria:

    Participants who are already performing >30 min. of endurance exercise/day for ≥ 3x/week (Borg scale-- "hard" or "somewhat hard") within 30 days of screening.
    Participants who are already performing resistance exercise ≥ 3x/week within 30 days of screening.

    Neurologic
    Patients participating in other ALS-related clinical drug trials
    Participants with history of ALS symptoms over 5 years duration
    Inability to obtain consent (psychiatric or dementing illness)
    History of neuromuscular dysfunction not related to ALS

    Cardiac
    Patents with clinically significant ECG abnormalities
    Uncontrolled hypertension (SBP>160 or DBP>110)
    Recent history of angina (within the last 2 years)
    Recent history of abnormal stress test (within the last 2 years)
    Symptomatic severe aortic stenosis
    Active endocarditis
    Symptomatic heart failure

    Respiratory
    Subjects with a history of respiratory dysfunction not related to ALS (i.e. COPD)

    General
    Subjects with chronic infectious disease including HIV, hepatitis B or C.
    History of substance abuse within the past year
    Patients who have a history of poor compliance to medical regimens or study requirements.
    Uncontrolled diabetes
    Recent embolism (within the last 6 months)
    Severe orthopedic conditions that would prohibit exercise

    Pregnancy
    Female subjects who are pregnant or planning to become pregnant.
    Female subjects of childbearing potential who are not practicing contraception.

    Concomitant Medications
    Subjects who are taking more than 1000 IU of Vitamin C per day
    Subjects who are taking more than 400 IU of Vitamin E per day
    Subjects who are taking more than 600 mg of Coenzyme Q-10 per day
    Subjects who are taking more than 2 g of creatine per day

  • Site Contact Information

    Cedars-Sinai Medical Center
    Los Angeles, California 90048
    United States

    Johns Hopkins University
    Kristen M Riley, PhD / .(JavaScript must be enabled to view this email address) / 410-955-8511
    Baltimore, Maryland 21287
    United States

    Massachusetts General Hospital
    Amy Swartz / .(JavaScript must be enabled to view this email address) / 617-724-0815
    Charlestown, Massachusetts 02129
    United States

    Carolinas Medical Center
    Carissa Ingram / .(JavaScript must be enabled to view this email address) / 704-446-1982
    Charlotte, North Carolina 28207
    United States

  • Study Results

    Click here to download a publication of the study results.