Status:
COMPLETED
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 exerci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01521728
Start Date
January 1 2012
End Date
February 1 2016
Last Update
April 19 2016
Active Locations (4)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
4
Carolinas Medical Center
Charlotte, North Carolina, United States, 28207