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Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326622
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Anna Caroline Braga, University of Lisbon

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: standard care Other: moderate exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: single blinded
Primary Purpose: Supportive Care
Official Title: The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : March 30, 2015
Actual Study Completion Date : June 30, 2015


Arm Intervention/treatment
Experimental: moderate exercise + standard care
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.
Other: standard care
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.
Other Names:
  • Range of Motion
  • Gait Training
  • Balance training

Other: moderate exercise
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.

Active Comparator: Standard care
This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.
Other: standard care
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.
Other Names:
  • Range of Motion
  • Gait Training
  • Balance training




Primary Outcome Measures :
  1. Functional decline between start and end of the study [ Time Frame: between baseline and 6 months later ]

    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 :
  1. Performance of Cardiopulmonary Exercise testing variables throughout the study [ Time Frame: at study entry and 6 months later. ]
    Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.

  2. Changes on the Dioxide Carbon output (VCO2) measurement [ Time Frame: at study entry and 6 months later ]
    Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.

  3. Changes on the Minute Ventilation (VE) measurement [ Time Frame: at study entry and 6 months later ]
    Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


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): NCT03326622


Sponsors and Collaborators
University of Lisbon
Investigators
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Study Director: Mamede de Carvalho, MD PhD Institute of Molecular Medicine
Principal Investigator: Anabela Pinto, MD PhD Institute of Molecular Medicine

Publications:
World Health Organization - Physical activity Fact Sheet nº385. In www.who.int/mediacentre/factsheets/fs385/en/ January; 2015
Wasserman K, Hansen JE, Sue DY, Stringer WW, Sietsema KE, Sun X-G, Whipp BJ.Principles of Exercise Testing and Interpretation: Including Pathophysiology and Clinical Applications, 5th edn; eds (2012). Lippincott Williams & Wilkins, Philadelphia, USA.ISBN 978-1-60913-899-8

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Caroline Braga, Investigator, University of Lisbon
ClinicalTrials.gov Identifier: NCT03326622    
Other Study ID Numbers: FCT - SFRH/BD/78413/2011
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Caroline Braga, University of Lisbon:
Amyotrophic Lateral Sclerosis
aerobic exercise
functional outcome
non-invasive ventilation
oxygen uptake
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