Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients
NCT ID: NCT03326622
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2013-07-01
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
Standard care
This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease duration from first symptoms between 6-24 months to exclude slow and fast progression
* ALSFRS-R ≥ 30
* FVC (%predicted) ≥ 70%
Exclusion Criteria
* 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).
18 Years
90 Years
ALL
No
Sponsors
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University of Lisbon
OTHER
Responsible Party
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Anna Caroline Braga
Investigator
Principal Investigators
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Mamede de Carvalho, MD PhD
Role: STUDY_DIRECTOR
Institute of Molecular Medicine
Anabela Pinto, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Molecular Medicine
References
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Other Identifiers
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FCT - SFRH/BD/78413/2011
Identifier Type: -
Identifier Source: org_study_id