Study Purpose: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.
Amyotrophic Lateral Sclerosis
Type of Intervention:
standard care, moderate exercise
Study Chair(s)/Principal Investigator(s):
Mamede de Carvalho, MD PhD, Institute of Molecular Medicine, Anabela Pinto, MD PhD, Institute of Molecular Medicine
Coordinating Center Contact Information
Full Study Summary:
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.
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.
University of Lisbon
Estimated Study Start Date:
07 / 01 / 2013
Estimated Study Completion Date:
06 / 30 / 2015
Posting Last Modified Date:
11 / 01 / 2017
Date Study Added to neals.org:
10 / 31 / 2017
90 YearsInclusion 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%
- 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).