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Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standard care
moderate exercise
Sponsored by
University of Lisbon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, aerobic exercise, functional outcome, non-invasive ventilation, oxygen uptake

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS
  • Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
  • ALSFRS-R ≥ 30
  • FVC (%predicted) ≥ 70%

Exclusion Criteria:

  • Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training;
  • Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
  • Signs of associated dementia or psychiatric disorders.

Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    moderate exercise + standard care

    Standard care

    Arm Description

    This group performed a moderate exercise protocol with training zone determined by Cardiopulmonary Exercise testing added to standard care program based on American Academy of Neurology guidelines.

    This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.

    Outcomes

    Primary Outcome Measures

    Functional decline between start and end of the study
    It was used the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R),which rates the functionality of the ALS patients in performing activities involving 4 different areas through 3 sub-scores - bulbar, spinal [upper and lower limb] and also the respiratory function. Each of its questions is rated from 0 (total inability) to 4 points (no functional limitation). The last three questions address the respiratory function (dyspnea, orthopnea, respiratory insufficiency) and assess the respiratory functional outcome. The sub-scores rating: Bulbar sub-score between 0 - 12, the spinal score between 0 - 24 and the respiratory sub-score between 0 - 12.The sum of the sub-scores provide an ALSFRS-R total score = 48. Higher values represent a better functionality.

    Secondary Outcome Measures

    Performance of Cardiopulmonary Exercise testing variables throughout the study
    Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.
    Changes on the Dioxide Carbon output (VCO2) measurement
    Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.
    Changes on the Minute Ventilation (VE) measurement
    Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.

    Full Information

    First Posted
    October 21, 2017
    Last Updated
    October 30, 2017
    Sponsor
    University of Lisbon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03326622
    Brief Title
    Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients
    Official Title
    The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2013 (Actual)
    Primary Completion Date
    March 30, 2015 (Actual)
    Study Completion Date
    June 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Lisbon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluated the influence of a tailored aerobic exercise protocol on the functional outcome in ALS patients. In addition, the investigators compare some CPET variables collected during exercise testing in both groups.
    Detailed Description
    This work aimed to evaluate the effects of a moderate aerobic exercise with controlled intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the functional status in ALS patients versus standard care. Additionally, the investigators explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study. Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using: Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and Oxygen saturation provided by pulse oximetry. CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems. Intervention: G1(Interventional group) performed moderate exercise protocol two times/week in a treadmill in the lower range of the training zone determined by CPET + standard care (range of motion exercise, gait and balance training under continuous pulse oximetry observation). G2 (control group) performed a standard care exercise program at home or at other rehabilitation units without pulse oximetry observation.

    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, aerobic exercise, functional outcome, non-invasive ventilation, oxygen uptake

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    single blinded
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    moderate exercise + standard care
    Arm Type
    Experimental
    Arm Description
    This group performed a moderate exercise protocol with training zone determined by Cardiopulmonary Exercise testing added to standard care program based on American Academy of Neurology guidelines.
    Arm Title
    Standard care
    Arm Type
    Active Comparator
    Arm Description
    This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.
    Intervention Type
    Other
    Intervention Name(s)
    standard care
    Other Intervention Name(s)
    Range of Motion, Gait Training, Balance training
    Intervention Description
    A standard care program based on American Academy of Neurology guidelines (Range Of Motion (ROM) exercises, gait and balance training )at home or another rehabilitation units without intensity control.
    Intervention Type
    Other
    Intervention Name(s)
    moderate exercise
    Intervention Description
    A moderate exercise protocol two times per week in a treadmill in the lower range of the training zone determined by Cardiopulmonary Exercise Testing, monitored by continuous pulse oximetry evaluation.
    Primary Outcome Measure Information:
    Title
    Functional decline between start and end of the study
    Description
    It was used the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R),which rates the functionality of the ALS patients in performing activities involving 4 different areas through 3 sub-scores - bulbar, spinal [upper and lower limb] and also the respiratory function. Each of its questions is rated from 0 (total inability) to 4 points (no functional limitation). The last three questions address the respiratory function (dyspnea, orthopnea, respiratory insufficiency) and assess the respiratory functional outcome. The sub-scores rating: Bulbar sub-score between 0 - 12, the spinal score between 0 - 24 and the respiratory sub-score between 0 - 12.The sum of the sub-scores provide an ALSFRS-R total score = 48. Higher values represent a better functionality.
    Time Frame
    between baseline and 6 months later
    Secondary Outcome Measure Information:
    Title
    Performance of Cardiopulmonary Exercise testing variables throughout the study
    Description
    Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.
    Time Frame
    at study entry and 6 months later.
    Title
    Changes on the Dioxide Carbon output (VCO2) measurement
    Description
    Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.
    Time Frame
    at study entry and 6 months later
    Title
    Changes on the Minute Ventilation (VE) measurement
    Description
    Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.
    Time Frame
    at study entry and 6 months later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consecutive patients diagnosed with definite, probable, or probable laboratory supported ALS Disease duration from first symptoms between 6-24 months to exclude slow and fast progression ALSFRS-R ≥ 30 FVC (%predicted) ≥ 70% Exclusion Criteria: Other medical conditions, like cardiac insufficiency and lung disorders or others conditions limiting exercise training; Heavy smoking habits with laboratorial evidence of significant bronchial constriction; Signs of associated dementia or psychiatric disorders. Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mamede de Carvalho, MD PhD
    Organizational Affiliation
    Institute of Molecular Medicine
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Anabela Pinto, MD PhD
    Organizational Affiliation
    Institute of Molecular Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

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