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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00160004
Other study ID # ALSICEJ1
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received September 9, 2005
Last updated June 5, 2009
Start date March 2006
Est. completion date December 2008

Study information

Verified date June 2009
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Behavioral:
Intensive Controlled Exercise


Locations

Country Name City State
Netherlands Department of Allied health Occupations, Radboud University Nijmegen Medical Centre Nijmegen Gelderland

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness measured with Astrand submaximal test
Secondary Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
Secondary Functional status measured with ALS-FRS-r Rating scale
Secondary Quality of life with ALS-AQ40 Questionnaire
Secondary Fatigue measured with CIS Questionnaire
Secondary Pulmonary function measured with FVC
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