- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521728
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
April 18, 2016 updated by: Nicholas Maragakis, MD, Johns Hopkins University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Massachusetts
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Charlestown, Massachusetts, United States, 02129
- Massachusetts General Hospital
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Carolinas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Resistance Exercise
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.
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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.
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Active Comparator: Endurance 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.
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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.
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Active Comparator: Stretching/Range-of-Motion 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.
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Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resistance Exercise Tolerability
Time Frame: 6 months
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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.
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6 months
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Endurance Exercise Tolerability
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital Capacity
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)
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6 months
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ALS Functional Rating Scores
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)
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6 months
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Muscle Strength
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on measures of muscle strength
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6 months
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Spasticity
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on spasticity
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6 months
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Fatigue
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on fatigue
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6 months
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Quality of Life
Time Frame: 6 months
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Evaluate the effect of resistance and endurance exercise on patient quality of life
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas M Maragakis, MD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
January 24, 2012
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Estimate)
April 19, 2016
Last Update Submitted That Met QC Criteria
April 18, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00022650
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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