This project assessed muscle oxidative metabolism and fatigue in patients affected by amyotrophic lateral sclerosis (ALS) undergoing to three months of individualized cardiovascular and strength training. Muscle oxidative metabolism and strength will be assessed by non-invasive methods, such as near-infrared spectroscopy (NIRS) and mechanomyography (MMG). NIRS is a technique giving indications on the capacity of oxygen extraction of muscles during exercise. MMG allows analyzing the pattern of motor unit recruitment and related fatigue. The investigators will also assess the effects of training on pain tolerance and quality of life (QoL) by the Brief Pain Inventory and the McGill Quality of Life questionnaires, using the validated Italian versions. Patients will be assessed longitudinally before (time T0) and after three months of individualized training (time T1). After one month of de-training (time T2) the investigators will assess the hypothetic persistence of any treatment-related effect. The effect of three months-osteopathic treatment (osteo) on pain and QoL will be assessed as well.
Single blind pilot trial assessing the efficacy and side effects of active training or osteopathic manipulative treatment in ALS. Interventions will be administered for three months (plus one month without intervention) by specialized personnel. Primary outcome measures will include: exercise tolerance and muscle oxygen extraction capacity, side effects. Secondary outcome measures will include: pain, QoL and disease progression scales.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Frequency: 60 min three times/week 1. 20 min: aerobic training on bicycle ergometer. 2. 20 min: strength training at 60% of maximal load. 3. 20 min: proprioception and stretching exercises.
Frequency: 60 min weekly
change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks
exercise tolerance assessed by Cardio pulmonary Exercise Test (CPET); oxygen extraction on vastus lateralis, respiratory muscle and hand thenar eminence muscles assessed by Near Infrared Spectroscopy (NIRS)
Time frame: 12 weeks
appearance of side effects during the period of intervention administration
Time frame: 12 weeks
change of pain at 12 weeks
Brief Pain Inventory (BPI)
Time frame: 12 weeks
change of quality of life at 12 weeks
McGill Quality of Life
Time frame: 12 weeks
change of the neurological functional status at 12 weeks
ALS Functional Rating Scale-revised (ALSFRS-R)
Time frame: 12 weeks
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