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NCT Number: NCT03326622

Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Range of Motion, Gait Training, Balance training

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.

Primary outcomes

  1. Functional decline between start and end of the study

    Time frame: 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 outcomes

  1. Performance of Cardiopulmonary Exercise testing variables throughout the study

    Time frame: at study entry and 6 months later.

    Changes on the oxygen uptake (VO2peak) measurement following an aerobic exercise protocol compared to standard care.

  2. Changes on the Dioxide Carbon output (VCO2) measurement

    Time frame: at study entry and 6 months later

    Changes on the Dioxide Carbon output (VCO2) following an aerobic exercise protocol compared to standard care.

  3. Changes on the Minute Ventilation (VE) measurement

    Time frame: at study entry and 6 months later

    Changes on Minute ventilation (VE) following an aerobic exercise protocol compared to standard care.

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2017
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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