Sport Therapy and Osteopathy Manipulative Treatment in ALS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sport Therapy for Contrasting the Deterioration of Muscle Oxidative Metabolism in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) - Project ME_E_SLA

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Sport therapy
* Other: Osteopathic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of ALS early stages of disease able to perform exercise with major muscle groups. Exclusion Criteria: non-invasive ventilation (NIV) tracheostomy coronaropathy ongoing infectious diseases cognitive deficits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active; sport therapy<br>active exercise carefully calibrated on residual capacities. | Other: Sport therapy<br>* Frequency: 60 min three times/week 20 min: aerobic training on bicycle ergometer. 20 min: strength training at 60% of maximal load. 20 min: proprioception and stretching exercises.<br>|
| Experimental: passive; osteopathic treatment<br>manipulative treatment according to osteopathic principles. | Other: Osteopathic treatment<br>* Frequency: 60 min weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks | 
| appearance of side effects during the period of intervention administration |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of pain at 12 weeks | Brief Pain Inventory (BPI) | 12 weeks | 
| change of quality of life at 12 weeks | McGill Quality of Life | 12 weeks | 
| change of the neurological functional status at 12 weeks | ALS Functional Rating Scale-revised (ALSFRS-R) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism