Remote versus face-to-face home-based exercise programme in people with amyotrophic lateral sclerosis: protocol for a randomised clinical trial.

Autor:	Souza AA; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil alvss.aline@gmail.com.; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Silva STD; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Pondofe KM; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Resqueti VR; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Melo LP; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Valentim RAM; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil., Ribeiro TS; Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.; Laboratory of Technological Innovation in Health, Federal University of Rio Grande do Norte, Natal, Brazil.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 May 26; Vol. 12 (5), pp. e056323. Date of Electronic Publication: 2022 May 26.
DOI:	10.1136/bmjopen-2021-056323
Abstrakt:	Introduction: Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease with variable and complex clinical manifestations that requires a multidisciplinary approach. However, face-to-face treatment in this population may experience barriers, such as difficulty accessing physical therapists or other professionals. As a result, strategies (eg, telerehabilitation) emerged to facilitate treatment and physical therapy monitoring. This study aims to evaluate the effects of remote versus face-to-face home-based exercise programmes on clinical outcomes and treatment adherence of people with ALS. Methods and Analysis: This is a single-blind randomised clinical trial protocol that will include 44 people with clinical diagnosis of ALS at any clinical stage and aged between 18 and 80 years. Participants will be randomised into two groups after face-to-face evaluation and perform a home-based exercise programme three times a week for 6 months. A physical therapist will monitor the exercise programme once a week remotely (phone calls-experimental group) or face-to-face (home visits-control group). The primary outcome measure will be functional capacity (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised). Secondary outcomes will include disease severity (Amyotrophic Lateral Sclerosis Severity Scale), fatigue (Fatigue Severity Scale), pain (Visual Analogue Scale and body pain diagram), adverse events and adherence rate. Outcomes will be initially evaluated face-to-face and revaluated remotely every 2 months and 1 month after interventions. Linear mixed models will compare outcome measures between groups and evaluations (α=5%). Ethics and Dissemination: This study was approved by the research ethics committee of Hospital Universitário Onofre Lopes/Universidade Federal do Rio Grande do Norte (no. 3735479). We expect to identify the effects of an exercise programme developed according to ALS stages and associated with remote or face-to-face monitoring on clinical outcomes using revaluations and follow-up after interventions. Trial Registration Number: Brazilian Registry Clinical Trials (RBR-10z9pgfv). Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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