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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00160004
Enrollment
20
Registered
2005-09-12
Start date
2006-03-31
Completion date
2008-12-31
Last updated
2009-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

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.

Interventions

BEHAVIORALIntensive Controlled Exercise

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Cardiorespiratory fitness measured with Astrand submaximal test

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026