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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Johns Hopkins University
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Nicholas Maragakis, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01521728
First received: January 24, 2012
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 Intervention
Amyotrophic Lateral Sclerosis
Other: Resistance Exercise
Other: Endurance Exercise
Other: Stretching/Range-of-Motion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Resistance Exercise Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Endurance Exercise Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Vital Capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)

  • ALS Functional Rating Scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)

  • Muscle Strength [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on measures of muscle strength

  • Spasticity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on spasticity

  • Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on fatigue

  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the effect of resistance and endurance exercise on patient quality of life


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521728

Contacts
Contact: Kristen M Riley, PhD 4109558511 kriley15@jhmi.edu
Contact: Lora L Clawson, CRNP 4109558511 lclawson@jhmi.edu

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Peggy Allred, PT, DPT    424-315-2694    Peggy.allred@cshs.org   
Principal Investigator: Richard Lewis, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kristen M Riley, PhD    410-955-8511    kriley15@jhmi.edu   
Principal Investigator: Nicholas M Maragakis, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Kellen Haley    617-726-1844    kehaley@partners.org   
Principal Investigator: Nazem Atassi, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Rita Rouse    704-446-1902    Rita.Rouse@carolinashealthcare.org   
Principal Investigator: Benjamin Brooks, MD         
Sponsors and Collaborators
Johns Hopkins University
ALS Association
Investigators
Principal Investigator: Nicholas M Maragakis, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Nicholas Maragakis, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01521728     History of Changes
Other Study ID Numbers: NA_00022650
Study First Received: January 24, 2012
Last Updated: October 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
ALS
Exercise
Resistance
Endurance

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 20, 2014