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

NCT00160004 | Terminated Phase 1

• 1 other identifier: ALSICEJ1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Exercise; Fatigue; Quality-of-life

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness measured with Astrand submaximal test

Secondary Outcomes (5)

• 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

Interventions

Intensive Controlled Exercise BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Department of Allied health Occupations, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

• Drory VE, Goltsman E, Reznik JG, Mosek A, Korczyn AD. The value of muscle exercise in patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001 Oct 15;191(1-2):133-7. doi: 10.1016/s0022-510x(01)00610-4.

  PMID: 11677004 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Activity; Fatigue

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marten Munneke, PhD

  Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 2006
• Study Completion: December 1, 2008
• Last Updated: June 8, 2009

Record last verified: 2009-06

Locations

NL (1)