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| Name | Class |
|---|---|
| ALS Association | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Capacity | Evaluate the effect of resistance and endurance exercise on slow vital capacity (SVC) | 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) |
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Inclusion Criteria:
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
Cardiac
Respiratory
General
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas M Maragakis, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Johns Hopkins University |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
| 6 months |
| Muscle Strength | Evaluate the effect of resistance and endurance exercise on measures of muscle strength | 6 months |
| Spasticity | Evaluate the effect of resistance and endurance exercise on spasticity | 6 months |
| Fatigue | Evaluate the effect of resistance and endurance exercise on fatigue | 6 months |
| Quality of Life | Evaluate the effect of resistance and endurance exercise on patient quality of life | 6 months |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28207 | United States |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |