Sport Therapy and Osteopathy Manipulative Treatment in ALS

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Osteopathic treatment; Other: Sport therapy

• Registration Number: NCT02548663
• Lead Sponsor: University of Milano Bicocca

Brief Summary

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

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
passive; osteopathic treatment	Osteopathic treatment	manipulative treatment according to osteopathic principles.
active; sport therapy	Sport therapy	active exercise carefully calibrated on residual capacities.

Primary Outcome Measures

Name	Time	Method
change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks	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)
appearance of side effects during the period of intervention administration	12 weeks

Secondary Outcome Measures

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