Innovative and disruptive technologies to prescribe, encourage, and evaluate physical exercise in healthy adults: a protocol of exploratory study followed by a noninferiority, investigator-blinded randomized clinical trial

Trials

Study Protocol

Italo Adriano Moraes de Freitas¹  Fernanda Laís Loro²  Cintia Laura Pereira de Araújo²  Riane Martins²  Pedro Dal Lago²  Denis Lima do Rosário³  Marcos César da Rocha Seruffo³  Jéferson Nobre⁴  Lucio Rene Prade⁵  Cristiano Bonato Both⁵ 

[1] Ludus Studio, Quartorze Street, 6, CEP 67113-510, Coqueiro Ananindeua, PA, Brazil;Universidade Federal de Ciências da Saúde de Porto Alegre, Sarmento Leite Street, 245, CEP: 90050-170, Porto Alegre, RS, Brazil;Universidade Federal do Pará, Augusto Correa Street, 01, CEP 66075110, Belém, PA, Brazil;Universidade Federal do Rio Grande do Sul, Bento Gonçalves Avenue, 95000, CEP 91501970, Porto Alegre, RS, Brazil;Universidade do Vale do Rio dos Sinos, Unisinos Avenue, 950, CEP: 93022-750, São Leopoldo, RS, Brazil;

关键词: Exercise training;    Exercise intensity;    Mobile applications;    Sedentary lifestyle;   

DOI  :  10.1186/s13063-023-07747-6

 received in 2023-08-22, accepted in 2023-10-24,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundCardiovascular diseases are a leading cause of mortality worldwide. A significant contributing factor to this mortality is the lack of engagement in preventive activities. Consequently, strategies for enhancing adherence to and duration of physical activity (PA) have become pivotal. This project aims to create and validate innovative, disruptive, and secure technologies that ensure appropriate exercise intensity, bolster adherence to PA, and monitor health biomarker responses pre-, during, and post-physical activity.MethodsThis exploratory study, followed by a noninferiority, investigator-blinded randomized clinical trial, will be divided into three phases: (1) development and validation of a sensor for real-time biofeedback during a functional assessment test; (2) integration of biofeedback and gamification into an app for the structured prescription of physical training within a controlled setting; and (3) implementation of biofeedback and gamification into an app for the prescription and monitoring of physical training in an uncontrolled setting. Phase 1 entails a validation test of a biosensor—monitoring heart rate (HR) and steps—during a modified shuttle walk test. In phase 2, the biosensor interfaces with a gamified smartphone application. The training regimen spans 6 weeks, 5 days weekly, with each session lasting 60 min: a five-min warm-up involving stationary gait, followed by 50 min of training at the target HR on the step and concluding with a five-min cool-down at a stationary pace. After 6 weeks of training, a new functional capacity test is conducted. Phase 3 involves an investigator-blinded, randomized clinical trial to demonstrate noninferiority. Participants are randomly assigned to either the intervention group (IG) or the control group (CG). IG participants practice exercise using the gamified application in an uncontrolled environment according to the prescribed method outlined in phase 2. CG participants receive PA practice guidelines exclusively.DiscussionAnticipated outcomes include improved exercise adherence through the gamified application, better maintenance of prescribed exercise intensity, and enhanced health biomarkers. The results of this study will inform health-related decision-making.Trial registrationThe study protocol received approval from the Ethics Committee of Universidade Federal de Ciências da Saúde de Porto Alegre (54,492,221.80000.5345) and has been registered with the Brazilian Registry of Clinical Trials (ReBEC, RBR-359p69v).

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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