The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

Phase 1

Terminated

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00160004
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. One of the members of this team is the physical therapist. The aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). The primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in ALS can maintain or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Study Start: 2006-03
• Study Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-05
• Last Update Posted: 2009-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS

Exclusion Criteria

• Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness measured with Astrand submaximal test

Secondary Outcome Measures

Name	Time	Method
Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
Functional status measured with ALS-FRS-r Rating scale
Quality of life with ALS-AQ40 Questionnaire
Fatigue measured with CIS Questionnaire
Pulmonary function measured with FVC

Trial Locations

Locations (1)

Department of Allied health Occupations, Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands