Study of the Effects Strengthening Exercises in Individuals With ALS

NCT00204464 | Completed Phase 2

• 2 other identifiers: ALS_EXALSA-CM Grant
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Exercise

Outcome Measures

Primary Outcomes (1)

• Function - ALSFRS

Secondary Outcomes (4)

• MVIC

• FVC

• Fatigue

• SF-36

Interventions

Exercise PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• definite and/or probable diagnosis of ALS
• early stages of the disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Washington University School of Medicine: collaborator
• Columbia University: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vanina PM Dal Bello-Haas, PhD, BScPT

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 20, 2005
• Study Completion: December 1, 2004
• Last Updated: November 4, 2005

Record last verified: 2004-12

Locations

US (1)