Objective
Exercise may be physically and psychologically important for people with
ALS
, especially in the earlier stages of the disease, and, as a consequence, current
ALS
clinical management includes individualized rehabilitation as part of multidisciplinary care because. However, while recent studies focused on which type of exercise is more indicated to
ALS
patients, there is no evidence at which frequency training sessions should be performed.
Methods
We performed an assessor blinded randomized clinical trial to investigate the superiority of two different frequencies of exercise on rate of progression in
ALS
. We enrolled 65 patients in two groups: intensive exercise regimen (
IER
, five sessions/week) versus usual exercise regimen (
UER
, two sessions/week). The primary aim was to assess if
IER
decreased disease progression, measured through Amyotrophic Lateral Sclerosis Functional Rating Scale‐Revised, with respect to
UER
. Secondary aims included assessment of adverse events, tracheostomy‐free survival, motor and respiratory functions, fatigue, quality of life and caregiver burden. Treatment regimen consisted for both groups of the same kind of exercise including aerobic training, endurance training, stretching or assisted active mobilization, differing for frequency of intervention.
Results
No significant changes in disease progression were found in patients under
IER
versus
UER
. At the end of the study, there were no significant differences between the two groups in survival, respiratory function, time to supporting procedures, and quality of life. Adverse events, fatigue, and caregiver burden were not different between the two treatment regimens.
Conclusions
Despite some limitations, our trial demonstrated that high‐frequency physical exercise was not superior to
UER
on
ALSFRS
‐R scores, motor and respiratory functions, survival, fatigue, and quality of life of
ALS
patients.