NCT03326622

Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Lisbon · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-03-30
• Completion: 2015-06-30
• First posted: 2017-10-31
• Last updated: 2017-11-01