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Completed

NCT Number: NCT01521728

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Behavior Central Nervous System Diseases Metabolic Diseases Motor Activity Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance Exercise

Other

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 Exercise

Other

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/Range-of-Motion

Other

Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • ALS Association

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2012
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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