Effects of a home based exercise protocol with remote and face-to-face monitoring of individuals with Amyotrophic Lateral Sclerosis: a randomized clinical trial
Neuromuscular diseases; Telerehabilitation; Physiotherapy
Introduction: Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease with variable and complex clinical manifestations, requiring a multidisciplinary approach. However, face-to-face treatment in this population may encounter some barriers, such as the difficulty of traveling to treatment centers and access to physical therapists or other professionals. As a way of overcoming these barriers, new strategies were implemented in the health systems, among them telerehabilitation, to facilitate the treatment and physical therapy follow-up of these individuals. Objective: To evaluate the effects of a home exercise protocol with face-toface and remote monitoring on clinical outcomes and treatment adherence in patients with ALS Methods: This is a randomized, blinded clinical trial, which included adult individuals of both sexes, aged between 18 and 80 years, with a definite, probable or possible clinical diagnosis of ALS. After the initial face-to-face assessment, the participants were randomized into two groups, which performed a protocol of home exercises (according to the stage of the disease), three times a week for six months. The execution of the exercise protocol was monitored weekly (1x/week), remotely (via phone calls) for the experimental group (EG) and in person (with visits from the team) for the control group (CG). The outcome measures assessed were: functional physical capacity (Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised – ALSFRS-r), disease severity (Amyotrophic Lateral Sclerosis Severity Scale – Egela), fatigue (Fatigue Severity Scale – FSS) and pain (Visual Analog Scale and Body Diagram). Outcome reassessments will take place remotely every two months, during the intervention period, and one month after the intervention ends. Descriptive statistics were used to present the preliminary data and the mixed linear model will be used to compare the outcome measures between the groups and between the evaluation moments at the end of the intervention, with α=5% Results: Six participants were included, of both sexes, with a mean age of 57.8 (± 9.1) years, who had a predominance of the disease in its spinal form (66.6%), with a mean time of onset of symptoms between 1 and 2 years. Data related to outcome measures seem to demonstrate a decrease in the scores on the functional capacity and pain scale, an increase in the scores on the fatigue scale, and maintenance of the scores on the disease severity scale, when comparing the moments of initial assessment and reassessment after two months. As for the intervention, the participants showed good adherence to home treatment, performing the exercise protocol 2 to 3 times a week, following what was proposed. Only 5 participants reported fatigue during or after the intervention and there was no report of pain. Conclusion: According to the preliminary results, it can be concluded that the findings of the study are similar to what is found in the literature, regarding clinical and sociodemographic characteristics, as well as the behavior of the disease and its repercussions. So far, the intervention time to which the participants were submitted was not sufficient to detect statistical changes in the analyzed outcome measures. However, participants' adherence to the home exercise protocol has been high, and the exercises have been well tolerated