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

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.

• 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.