Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)

University of Milano Bicocca

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Sport therapy; Other: Osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02548663

ME_E_SLA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

active; sport therapy

Experimental group

Description:

active exercise carefully calibrated on residual capacities.

Treatment:

Other: Sport therapy

passive; osteopathic treatment

Experimental group

Description:

manipulative treatment according to osteopathic principles.

Treatment:

Other: Osteopathic treatment