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Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS) |
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Study Focus:
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 |
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Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS |
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Study Category:
Other: Exercise |
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Study Status:
Active, currently recruiting |
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Phase:
Not Applicable |
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Type:
Interventional Trial
with active agents/drugs only |
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Funding Source:
Johns Hopkins University |
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Study Chair(s)/Principal Investigator(s):
Nicholas Maragakis, MD, (Johns Hopkins University) |
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Clinicaltrials.gov ID:
NCT01521728 |
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NEALS Affiliated?
Yes
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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. |
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Participant Duration:
6 months |
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# of Subjects:
60 |
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Enrollment Start Date:
01/01/2012 |
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Posting Last Modified Date:
06/01/2012 |
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Date Study Added to alscortium.org:
01/31/2012 |
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| Eligibility Criteria |
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Gender:
Male & Female |
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Minimum Age:
18 |
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Maximum Age:
80 |
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Min Vital Capacity (% predicted normal):
70% |
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Time since Symptom Onset:
Not applicable |
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Time since Diagnosis:
Not applicable |
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Can participants use Riluzole?
Yes |
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Coordinating Center
Contact Information |
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| Lora L Clawson, CRNP |
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| lclawson@jhmi.edu |
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| 4109558511 |
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| Johns Hopkins University |
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Baltimore, Maryland 21287
UNITED STATES |
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Other Eligibility Criteria:
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
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Site Contact Information (Please click to show/hide) |
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| Maryland |
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Johns Hopkins University
Kristen M Riley, PhD
kriley15@jhmi.edu
410-955-8511
Baltimore, Maryland 21287
UNITED STATES |
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| Massachusetts |
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Massachusetts General Hospital
Amy Swartz
alswartz@partners.org
617-724-0815
Charlestown, Massachusetts 02129
UNITED STATES |
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| Missouri |
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Washington University
Charlie Wulf
wulfc@neuro.wustl.edu
314-362-6980
St. Louis, Missouri 63110
UNITED STATES |
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| North Carolina |
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Carolinas Medical Center
Carissa Ingram
Carissa.Ingram@carolinashealthcare.org
704-446-1982
Charlotte, North Carolina 28207
UNITED STATES |
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Familial ALS- ALS cases are inherited from 2 or more family members, affects 5-10% of ALS cases. Sporadic ALS- disease occurs at random with no clearly associated risk factors; most common form of ALS, affects approximately 90-95% ALS cases. Interventional trial- study where exposure, for example a drug, is assigned; used to determine the effectiveness of a treatment or intervention. With drugs and a placebo- One group gets the active treatment, the other gets the placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Observational study- study in which patients are observed and where no treatment is given; researcher has no control over the experiment because they are done in a more natural setting than an interventional trial. Trial Phase- objectives are different for each phase of a trial. - Phase I, drug is given to a small number of people to see if it is safe.
- Phase II begins to look at effectiveness of the drug.
- Phase III is considered the definitive test of whether a drug is effective, held at multiple research sites and much larger than the previous phases.
Vital Capacity- the maximum amount of air that can be expelled from the lungs after a maximum drawing of air into the lungs, measured by a spirometer and then scored as a percentage. |
