Study of the Effects Strengthening Exercises in Individuals With ALS

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00204464
• Lead Sponsor: University of Saskatchewan

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:

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.

Study Timeline

• Status Verified: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Last Update Submitted: 2005-11-03
• Last Update Posted: 2005-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Function - ALSFRS

Secondary Outcome Measures

Name	Time	Method
MVIC
FVC
Fatigue
SF-36

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States