Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: standard care; Other: moderate exercise

• Registration Number: NCT03326622
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2015-03-30
• Study Completion: 2015-06-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-21
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-30
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate exercise + standard care	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	standard care	This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.
moderate exercise + standard care	moderate exercise	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.

Primary Outcome Measures

Name	Time	Method
Functional decline between start and end of the study	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

Name	Time	Method
Performance of Cardiopulmonary Exercise testing variables throughout the study	at study entry and 6 months later.	Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.
Changes on the Dioxide Carbon output (VCO2) measurement	at study entry and 6 months later	Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.
Changes on the Minute Ventilation (VE) measurement	at study entry and 6 months later	Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.