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

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID: NCT01521728
Run by: Johns Hopkins University
People needed: 60
Starts: 2012-01-01
Expected to finish: 2016-02-01
Last updated by the study team: 2016-04-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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
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.

Where it is running

Cedars-Sinai Medical Center — Los Angeles, California, United States
Johns Hopkins University — Baltimore, Maryland, United States
Massachusetts General Hospital — Charlestown, Massachusetts, United States
Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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