Study of the Effects Strengthening Exercises in Individuals With ALS
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Exercise
Eligibility 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
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Function - ALSFRS
Secondary Outcome Measures
MVIC
FVC
Fatigue
SF-36
Full Information
NCT ID
NCT00204464
First Posted
September 14, 2005
Last Updated
November 3, 2005
Sponsor
University of Saskatchewan
Collaborators
Washington University School of Medicine, Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00204464
Brief Title
Study of the Effects Strengthening Exercises in Individuals With ALS
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Saskatchewan
Collaborators
Washington University School of Medicine, Columbia University
4. Oversight
5. Study Description
Brief 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:
an increase in muscle strength (maximum voluntary isometric contraction) as measured by quantitative muscle testing.
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).
a decrease in fatigue as measured by the Fatigue Severity Scale.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Function - ALSFRS
Secondary Outcome Measure Information:
Title
MVIC
Title
FVC
Title
Fatigue
Title
SF-36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanina PM Dal Bello-Haas, PhD, BScPT
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Effects Strengthening Exercises in Individuals With ALS
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