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Completed

NCT Number: NCT02548663

Sport Therapy and Osteopathy Manipulative Treatment in ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sport therapy

Other

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.

Osteopathic Treatment

Other

Frequency: 60 min weekly

Primary outcomes

  1. change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks

    Time frame: 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)

  2. appearance of side effects during the period of intervention administration

    Time frame: 12 weeks

Secondary outcomes

  1. change of pain at 12 weeks

    Time frame: 12 weeks

    Brief Pain Inventory (BPI)

  2. change of quality of life at 12 weeks

    Time frame: 12 weeks

    McGill Quality of Life

  3. change of the neurological functional status at 12 weeks

    Time frame: 12 weeks

    ALS Functional Rating Scale-revised (ALSFRS-R)

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy

Registry information

Official study title

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

Acronym: ME_E_SLA

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 14, 2015
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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