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Trial record 1 of 1 for:    NCT02548663
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Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)

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ClinicalTrials.gov Identifier: NCT02548663
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
Information provided by (Responsible Party):
University of Milano Bicocca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Sport therapy Other: Osteopathic treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sport Therapy for Contrasting the Deterioration of Muscle Oxidative Metabolism in Patients Affected by Amyotrophic Lateral Sclerosis (ALS) - Project ME_E_SLA
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: active; sport therapy
active exercise carefully calibrated on residual capacities.
 Other: Sport 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.
Experimental: passive; osteopathic treatment
manipulative treatment according to osteopathic principles.
 Other: Osteopathic treatment
Frequency: 60 min weekly


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548663


Sponsors and Collaborators
University of Milano Bicocca
Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
Investigators
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Principal Investigator: Francesca Lanfranconi, MD University of Milano Bicocca
More Information
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Publications:

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT02548663    
Other Study ID Numbers: ME_E_SLA
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by University of Milano Bicocca:
amyotrophic lateral sclerosis
sport therapy
osteopathic manual treatment
muscle oxidative metabolism
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases