Study of the Effects Strengthening Exercises in Individuals With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease MND) among
      adults. Motor neurons in the spinal cord, brain stem, and cerebral motor cortex degenerate
      and create a variety of upper (UMN) and lower motor neuron (LMN) clinical signs and symptoms,
      with the most frequently presenting symptom being focal weakness beginning in the leg, arm,
      or bulbar muscles, occurring in more than 70% of patients. Despite the high incidence of
      muscle weakness in patients with ALS, only two case studies evaluating the effects of
      specific muscle strengthening and endurance exercise programs in this patient population have
      been published, and the effects of resistive exercise programs in patients with ALS have not
      been well studied. Some have discouraged exercise programs in patients with ALS because of
      fear of overuse weakness. Yet, in patients with other neuromuscular diseases, resistive
      exercise programs have been shown to be beneficial and have not produced overuse weakness.
      The purpose of this study is to determine the effects of six months strengthening program on
      strength, function, fatigue and quality of life in individuals with ALS.
    

Detailed description: 
      The specific aims of this preliminary, prospective randomized study of individuals with ALS
      are to determine variability, describe trends over a 6-month time frame and to estimate
      differences between individuals with ALS who perform an upper and lower extremity
      strengthening program three times per week and a control group of individuals with ALS with
      respect to the following outcomes:

        1. an increase in muscle strength (maximum voluntary isometric contraction) as measured by
           quantitative muscle testing.

        2. an increase in functional activities as measured by The Amyotrophic Lateral Sclerosis
           Functional Rating Scale (ALSFRS)7 and the Schwab and England Rating Scale (SERS).

        3. a decrease in fatigue as measured by the Fatigue Severity Scale.

        4. an increase in quality of life as measured by the SF-36.Subjects will be randomized into
           two groups - experimental and control. Subjects in the control group will perform a
           daily stretching exercise program for a period of six months. Subjects in the
           experimental groups will perform a strengthening exercise program three times per week
           for a period of six months. All subjects will be evaluated at baseline and then monthly
           using the following outcome measures: (1) maximum voluntary isometric contraction; (2)
           Amyotrophic Lateral Sclerosis Functional Rating Scale; (3) Schwab and England Rating
           Scale; (3) Fatigue Severity Scale; (4) forced vital capacity; and, (5) the SF-36.
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Exercise