Study of the Effects Strengthening Exercises in Individuals With ALS

This study has been completed.
Sponsor:
Collaborators:
Washington University School of Medicine
Columbia University
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00204464
First received: September 14, 2005
Last updated: November 3, 2005
Last verified: December 2004
  Purpose

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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Procedure: Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Function - ALSFRS

Secondary Outcome Measures:
  • MVIC
  • FVC
  • Fatigue
  • SF-36

Estimated Enrollment: 40
Estimated Study Completion Date: December 2004
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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204464

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
University of Saskatchewan
Washington University School of Medicine
Columbia University
Investigators
Principal Investigator: Vanina PM Dal Bello-Haas, PhD, BScPT University of Saskatchewan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204464     History of Changes
Other Study ID Numbers: ALS_EX, ALSA-CM Grant
Study First Received: September 14, 2005
Last Updated: November 3, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Saskatchewan:
Amyotrophic Lateral Sclerosis
Exercise

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014