An interventional study of Resistance Exercise and Endurance Exercise in Amyotrophic Lateral Sclerosis, sponsored by Johns Hopkins University. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
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.
1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.
This study's enrollment of 60 is above the median of 37 across 678 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
Neurologic
Cardiac
Respiratory
General
Pregnancy
Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.
Other: Resistance Exercise
Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.
Other: Endurance Exercise
In ALS, stretching and range of motion are routinely recommended for the prevention of "frozen shoulder syndrome" and contractures resulting from weakness. The problem is compounded in ALS where upper motor neuron dysfunction may result in spasticity and incapacitating contractures with pain. Therefore, maintaining an aggressive program for stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
Other: Stretching/Range-of-Motion
Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.
Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.
Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
Resistance Exercise Tolerability
Evaluate the tolerability of RESISTANCE exercise in ALS subjects as measured by their ability to complete a 6 month study of a resistance exercise regimen.
Time frame: 6 months
Endurance Exercise Tolerability
Evaluate the tolerability of ENDURANCE exercise in ALS subjects as measured by their ability to complete a 6 month study of an endurance exercise regimen.
Time frame: 6 months
Vital Capacity
Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)
Time frame: 6 months
ALS Functional Rating Scores
Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)
Time frame: 6 months
Muscle Strength
Evaluate the effect of resistance and endurance exercise on measures of muscle strength
Time frame: 6 months
Spasticity
Evaluate the effect of resistance and endurance exercise on spasticity
Time frame: 6 months
Fatigue
Evaluate the effect of resistance and endurance exercise on fatigue
Time frame: 6 months
Quality of Life
Evaluate the effect of resistance and endurance exercise on patient quality of life
Time frame: 6 months
The record gives a start of Jan 2012, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →