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Sport Therapy and Osteopathy Manipulative Treatment in ALS (ME_E_SLA)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sport therapy
Osteopathic treatment
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    active; sport therapy

    passive; osteopathic treatment

    Arm Description

    active exercise carefully calibrated on residual capacities.

    manipulative treatment according to osteopathic principles.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 2, 2015
    Last Updated
    September 14, 2015
    Sponsor
    University of Milano Bicocca
    Collaborators
    Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02548663
    Brief Title
    Sport Therapy and Osteopathy Manipulative Treatment in ALS
    Acronym
    ME_E_SLA
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Milano Bicocca
    Collaborators
    Italian Academy of Osteopathic Medicine (AIMO), Saronno, Italy

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyotrophic Lateral Sclerosis
    Keywords
    amyotrophic lateral sclerosis, sport therapy, osteopathic manual treatment, muscle oxidative metabolism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    active; sport therapy
    Arm Type
    Experimental
    Arm Description
    active exercise carefully calibrated on residual capacities.
    Arm Title
    passive; osteopathic treatment
    Arm Type
    Experimental
    Arm Description
    manipulative treatment according to osteopathic principles.
    Intervention Type
    Other
    Intervention Name(s)
    Sport therapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Osteopathic treatment
    Intervention Description
    Frequency: 60 min weekly
    Primary Outcome Measure Information:
    Title
    change in the relationship between maximal oxygen consumption (VO2max) and muscle oxygen extraction capacity at 12 weeks
    Description
    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)
    Time Frame
    12 weeks
    Title
    appearance of side effects during the period of intervention administration
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    change of pain at 12 weeks
    Description
    Brief Pain Inventory (BPI)
    Time Frame
    12 weeks
    Title
    change of quality of life at 12 weeks
    Description
    McGill Quality of Life
    Time Frame
    12 weeks
    Title
    change of the neurological functional status at 12 weeks
    Description
    ALS Functional Rating Scale-revised (ALSFRS-R)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francesca Lanfranconi, MD
    Organizational Affiliation
    University of Milano Bicocca
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
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    24367951
    Citation
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