Sport Therapy and Osteopathy Manipulative Treatment in ALS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548663

Acronym

ME_E_SLA

Enrollment

Registered

2015-09-14

Start date

2014-06-30

Completion date

2015-05-31

Last updated

2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism

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.

Interventions

OTHERSport therapy

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.

OTHEROsteopathic treatment

Frequency: 60 min weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
change of pain at 12 weeks	12 weeks	Brief Pain Inventory (BPI)
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026