Effects of Exercise Training on Muscle Strength and Aerobic Capacity in Patients with Amyotrophic Lateral Sclerosis

Not Applicable

Recruiting

Conditions: Amyotrophic Lateral Sclerosis
Neurological - Neurodegenerative diseases
Musculoskeletal - Other muscular and skeletal disorders

Registration Number: ACTRN12617001244392

Lead Sponsor: Alessandra Ferri

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

Patients with definite, probable or possible amyotrophic lateral sclerosis (based on El Escorial Criteria)
- Age: >18 years old
- Patients able to understand and comply with the requirements of the entire study (i.e. cycle on a bicycle), and to give an informed consent

Exclusion Criteria

- Any medical disorder that would make physical activity contraindicated, including active malignancy, severe heart, lung, renal and liver failure
- Women who are pregnant or breastfeeding
- Participation in pharmacological studies within the last 30 days before screening

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in maximal aerobic capacity (VO2peak) evaluated via a metabolic cart during a graded cardiopulmonary exercise testing to exhaustion on a cycle ergometer[ Baseline and 12 weeks after the commencement of exercise training];Mean change in maximal strength of the leg extensors (particularly the quadriceps muscle) evaluated on a leg extension machine. The patients is sitting on a chair and extend (from a bending position) both legs at the same time, and then lower them back to the starting position. The strength will be evaluated as the maximal weight lifted by the patient no more than 10 times (10RM) .[ Baseline, 6 weeks and 12 weeks after the commencement of exercise training];Mean change in maximal capacity of muscle oxygen extraction, as evaluated during a graded cardiopulmonary exercise test on a cycle ergometer, by Near Infrared Spectroscopy with a small probe positioned on the belly of the vastus lateralis muscle.[ Baseline and 12 weeks after the commencement of exercise training]

Secondary Outcome Measures

Name	Time	Method
Mean change in physical function, evaluated by the 6 minutes walking test. The patient will walk at his own speed for 6min on a flat, hard surface. The distance that the patient can cover in this time will be recorded. [ Baseline and 12 weeks after the commencement of exercise training];Mean change in physical function, as evaluated by Timed Up and Go test. The patients will rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down. The time spent for this activity will be recorded.[ Baseline and 12 weeks after the commencement of exercise training];Mean change in the ALS functional rating scale revisited (ALSFRS-R)[ Baseline and 12 weeks after the commencement of exercise training];Assessment of quality of life using McGill Quality of Life questionnaire[ Baseline and 12 weeks after the commencement of exercise training]