Amyotrophic Lateral SclerosisNCT01521728
Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
A study testing Resistance Exercise, Endurance Exercise and Stretching/Range-of-Motion in people with Amyotrophic Lateral Sclerosis, run by Johns Hopkins University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Resistance Exercise, Endurance Exercise and Stretching/Range-of-Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Carolinas Medical Center
Charlotte, North Carolina, 28207
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Resistance Exercise, Endurance Exercise, Stretching/Range-of-Motion
- Keywords
- ALS, Exercise, Resistance, Endurance
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseOther
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 ExerciseOther
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-MotionOther
Stretching and range of motion exercise is widely accepted as a "standard of care" for ALS management.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise | Active comparator | 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. Receives: Other: Resistance Exercise |
| Endurance Exercise | Active comparator | 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. Receives: Other: Endurance Exercise |
| Stretching/Range-of-Motion Exercise | Active comparator | 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. Receives: Other: Stretching/Range-of-Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance Exercise Tolerability
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.
Measured: 6 months
Endurance Exercise Tolerability
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.
Measured: 6 months
Secondary outcomes (6)
Vital Capacity
Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC)
Measured: 6 months
ALS Functional Rating Scores
Evaluate the effect of resistance and endurance exercise on patients scores of the ALS Functional rating scale-revised (ALSFRS-R)
Measured: 6 months
Muscle Strength
Evaluate the effect of resistance and endurance exercise on measures of muscle strength
Measured: 6 months
Spasticity
Evaluate the effect of resistance and endurance exercise on spasticity
Measured: 6 months
Fatigue
Evaluate the effect of resistance and endurance exercise on fatigue
Measured: 6 months
Quality of Life
Evaluate the effect of resistance and endurance exercise on patient quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association
- Responsible party
- Principal investigator, Nicholas Maragakis, MD, Johns Hopkins University
- Investigators
- Nicholas M Maragakis, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521728
- Sponsor's protocol ID
- NA_00022650
- Status last verified
- Apr 2016
- First submitted
- 24 Jan 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Resistance and Endurance Exercise in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT01521728
- Acronym / sponsor ID
- NA_00022650
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Exercise, Resistance, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- ALS Association
- Study start
- Jan 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise | Active comparator | Other: Resistance ExerciseResistance 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 | Active comparator | Other: Endurance ExerciseEndurance 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 Exercise | Active comparator | Other: Stretching/Range-of-MotionIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
- Cardiac
- Respiratory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseResistance 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 |
| Endurance ExerciseEndurance 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 |
| Stretching/Range-of-MotionStretching and range of motion exercise is widely accepted as a "standard of care" for ALS management. | Other | Stretching/Range-of-Motion Exercise |
Primary outcome
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.
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.
6 secondary outcomes
Vital Capacity
Time frame: 6 months
ALS Functional Rating Scores
Time frame: 6 months
Muscle Strength
Time frame: 6 months
Spasticity
Time frame: 6 months
Fatigue
Time frame: 6 months
Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas M Maragakis, MD principal investigator
Johns Hopkins University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise, Endurance Exercise and Stretching/Range-of-Motion in people with Amyotrophic Lateral Sclerosis, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance Exercise Tolerability (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.