The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Cardiorespiratory fitness measured with Astrand submaximal test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Cardiorespiratory fitness measured with Astrand submaximal test
Secondary Outcomes
- 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