Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326622
• Other study ID #: FCT - SFRH/BD/78413/2011
• Status: Completed
• Phase: N/A
• First received: October 21, 2017
• Last updated: October 30, 2017
• Start date: July 1, 2013
• Est. completion date: June 30, 2015

Study information

• Verified date: October 2017
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 30, 2015
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Lisbon

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.
Secondary	Changes on the Dioxide Carbon output (VCO2) measurement	Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.	at study entry and 6 months later
Secondary	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