Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients

NCT03326622 | Completed

• 1 other identifier: FCT - SFRH/BD/78413/2011
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; aerobic exercise; functional outcome; non-invasive ventilation; oxygen uptake

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Performance of Cardiopulmonary Exercise testing variables throughout the study

  at study entry and 6 months later.

• Changes on the Dioxide Carbon output (VCO2) measurement

  at study entry and 6 months later

• Changes on the Minute Ventilation (VE) measurement

  at study entry and 6 months later

Study Arms (2)

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.

Other: standard care; Other: moderate exercise

Standard care

ACTIVE COMPARATOR

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

Other: standard care

Interventions

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.

Also known as: Range of Motion, Gait Training, Balance training

Standard care; moderate exercise + standard care

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.

moderate exercise + standard care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lisbon: lead

Related Publications (35)

• World Health Organization - Physical activity Fact Sheet nº385. In www.who.int/mediacentre/factsheets/fs385/en/ January; 2015

  BACKGROUND

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  PMID: 29666705 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Standard of Care; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mamede de Carvalho, MD PhD

  Institute of Molecular Medicine

  STUDY DIRECTOR

• Anabela Pinto, MD PhD

  Institute of Molecular Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 21, 2017
• First Posted: October 31, 2017
• Study Start: July 1, 2013
• Primary Completion: March 30, 2015
• Study Completion: June 30, 2015
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share