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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate exercise + standard care | Experimental | 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 | Active Comparator | This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between baseline and 6 months later |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at study entry and 6 months later. |
| Changes on the Dioxide Carbon output (VCO2) measurement |
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Inclusion Criteria:
Exclusion Criteria:
Note: None of the patients were on tube feeding, invasive or non-invasive mechanical ventilation at admission of study protocol (T1).
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| Name | Affiliation | Role |
|---|---|---|
| Mamede de Carvalho, MD PhD | Institute of Molecular Medicine | Study Director |
| Anabela Pinto, MD PhD | Institute of Molecular Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | World Health Organization - Physical activity Fact Sheet nº385. In www.who.int/mediacentre/factsheets/fs385/en/ January; 2015 | ||
| 15116368 | Background | Mahoney DJ, Rodriguez C, Devries M, Yasuda N, Tarnopolsky MA. Effects of high-intensity endurance exercise training in the G93A mouse model of amyotrophic lateral sclerosis. Muscle Nerve. 2004 May;29(5):656-62. doi: 10.1002/mus.20004. | |
| 22214352 |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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single blinded
|
| moderate exercise | Other | 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. |
|
Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care. |
| at study entry and 6 months later |
| Changes on the Minute Ventilation (VE) measurement | Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care. | at study entry and 6 months later |
| Background |
| Pinto S, Swash M, de Carvalho M. Respiratory exercise in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):33-43. doi: 10.3109/17482968.2011.626052. |
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| 29666705 | Derived | Braga ACM, Pinto A, Pinto S, de Carvalho M. The Role of Moderate Aerobic Exercise as Determined by Cardiopulmonary Exercise Testing in ALS. Neurol Res Int. 2018 Jan 31;2018:8218697. doi: 10.1155/2018/8218697. eCollection 2018. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |