Study of the Effects Strengthening Exercises in Individuals With ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)|
|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|
|Study Completion Date :||December 2004|
- Function - ALSFRS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|