Clinical trial NCT00160004: The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Official title: The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Exercise
Fatigue
Quality-of-life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiorespiratory fitness measured with Astrand submaximal test
Secondary outcomes:
measure: Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
measure: Functional status measured with ALS-FRS-r Rating scale
measure: Quality of life with ALS-AQ40 Questionnaire
measure: Fatigue measured with CIS Questionnaire
measure: Pulmonary function measured with FVC
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Allied health Occupations, Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands
name: Marten Munneke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.