Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS
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.
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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