Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

October 30, 2017 updated by: Anna Caroline Braga, University of Lisbon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: moderate exercise + 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.
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 Names:
  • Balance training
  • Range of Motion
  • Gait Training
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.
ACTIVE_COMPARATOR: Standard care
This group performed a standard care program based on American Academy of Neurology guidelines, without exercise intensity control.
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 Names:
  • Balance training
  • Range of Motion
  • Gait Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between baseline and 6 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at study entry and 6 months later.
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.
at study entry and 6 months later
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.
at study entry and 6 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Investigators

  • Study Director: Mamede de Carvalho, MD PhD, Institute of Molecular Medicine
  • Principal Investigator: Anabela Pinto, MD PhD, Institute of Molecular Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2013

Primary Completion (ACTUAL)

March 30, 2015

Study Completion (ACTUAL)

June 30, 2015

Study Registration Dates

First Submitted

October 21, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (ACTUAL)

October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCT - SFRH/BD/78413/2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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