Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Exercise, Resistance, Endurance
Eligibility Criteria
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.
Sites / Locations
- Cedars-Sinai Medical Center
- Johns Hopkins University
- Massachusetts General Hospital
- Carolinas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Resistance Exercise
Endurance Exercise
Stretching/Range-of-Motion 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.
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.
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.