Study of the Effects Strengthening Exercises in Individuals With ALS
|ClinicalTrials.gov Identifier: NCT00204464|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 4, 2005
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Procedure: Exercise||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Estimated Study Completion Date :||December 2004|
U.S. FDA Resources
- Function - ALSFRS
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204464
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Vanina PM Dal Bello-Haas, PhD, BScPT||University of Saskatchewan|