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Study of the Effects Strengthening Exercises in Individuals With ALS

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ClinicalTrials.gov Identifier: NCT00204464
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 4, 2005
Sponsor:
Collaborators:
Washington University School of Medicine
Columbia University
Information provided by:
University of Saskatchewan

September 14, 2005
September 20, 2005
November 4, 2005
Not Provided
Not Provided
Function - ALSFRS
Same as current
Complete list of historical versions of study NCT00204464 on ClinicalTrials.gov Archive Site
  • MVIC
  • FVC
  • Fatigue
  • SF-36
Same as current
Not Provided
Not Provided
 
Study of the Effects Strengthening Exercises in Individuals With ALS
Preliminary Study: The Effects of a Strengthening Program on Maximum Voluntary Isometric Contraction, Functional Abilities, Fatigue and Quality of Life in Individuals With Amyotrophic Lateral Sclerosis
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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Procedure: Exercise
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
December 2004
Not Provided

Inclusion Criteria:

  • definite and/or probable diagnosis of ALS
  • early stages of the disease

Exclusion Criteria:

  • history of neuromuscular dysfunction not related to ALS
  • active, confounding medical conditions
  • unwillingness or inability to comply with the protocol
  • FVC of less than 90% predicted
  • ALSFRS score of less than 30
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00204464
ALS_EX
ALSA-CM Grant
Not Provided
Not Provided
Not Provided
Not Provided
University of Saskatchewan
  • Washington University School of Medicine
  • Columbia University
Principal Investigator: Vanina PM Dal Bello-Haas, PhD, BScPT University of Saskatchewan
University of Saskatchewan
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP