We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521728
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Nicholas Maragakis, MD, Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Resistance Exercise Other: Endurance Exercise Other: Stretching/Range-of-Motion Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : January 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Other: 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.
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.
 Other: 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.
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.
 Other: Stretching/Range-of-Motion
Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Resistance Exercise Tolerability [ Time Frame: 6 months ]
    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.

  2. Endurance Exercise Tolerability [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Vital Capacity [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)

  2. ALS Functional Rating Scores [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)

  3. Muscle Strength [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on measures of muscle strength

  4. Spasticity [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on spasticity

  5. Fatigue [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on fatigue

  6. Quality of Life [ Time Frame: 6 months ]
    Evaluate the effect of resistance and endurance exercise on patient quality of life


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants with familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the WFN El Escorial criteria
  2. Participants who are ages 18-80, inclusive.
  3. Slow Vital Capacity (SVC) must be equal to or greater than 70% of predicted value
  4. ALSFRS-R score >30.
  5. Patients who are currently on any medications must be on a stable dose for the past 30 days.
  6. Participants must provide informed consent prior to completion of any study procedures.

Exclusion Criteria:

  1. 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.
  2. Participants who are already performing resistance exercise ≥ 3x/week within 30 days of screening.

  3. 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

  4. 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

  5. Respiratory

    • Subjects with a history of respiratory dysfunction not related to ALS (i.e. COPD)

  6. 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

  7. Pregnancy

    • Female subjects who are pregnant or planning to become pregnant.
    • Female subjects of childbearing potential who are not practicing contraception.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521728


Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Johns Hopkins University
ALS Association
Investigators
Layout table for investigator information
Principal Investigator: Nicholas M Maragakis, MD Johns Hopkins University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nicholas Maragakis, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01521728    
Other Study ID Numbers: NA_00022650
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Nicholas Maragakis, MD, Johns Hopkins University:
ALS
Exercise
Resistance
Endurance
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases