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
Abstract Background Cardiovascular 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 pivot...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-10-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07747-6 |
| _version_ | 1797636683899863040 |
|---|---|
| author | Fernanda Laís Loro Riane Martins Cintia Laura Pereira de Araújo Lucio Rene Prade Denis Lima do Rosário Marcos César da Rocha Seruffo Italo Adriano Moraes de Freitas Jéferson Nobre Cristiano Bonato Both Pedro Dal Lago |
| author_facet | Fernanda Laís Loro Riane Martins Cintia Laura Pereira de Araújo Lucio Rene Prade Denis Lima do Rosário Marcos César da Rocha Seruffo Italo Adriano Moraes de Freitas Jéferson Nobre Cristiano Bonato Both Pedro Dal Lago |
| author_sort | Fernanda Laís Loro |
| collection | DOAJ |
| description | Abstract Background Cardiovascular 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. Methods This 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. Discussion Anticipated 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 registration The 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). |
| first_indexed | 2024-03-11T12:37:37Z |
| format | Article |
| id | doaj.art-5f86aedc01b74db9bd1b1b300b834373 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T12:37:37Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-5f86aedc01b74db9bd1b1b300b8343732023-11-05T12:28:56ZengBMCTrials1745-62152023-10-0124111210.1186/s13063-023-07747-6Innovative 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 trialFernanda Laís Loro0Riane Martins1Cintia Laura Pereira de Araújo2Lucio Rene Prade3Denis Lima do Rosário4Marcos César da Rocha Seruffo5Italo Adriano Moraes de Freitas6Jéferson Nobre7Cristiano Bonato Both8Pedro Dal Lago9Universidade Federal de Ciências da Saúde de Porto AlegreUniversidade Federal de Ciências da Saúde de Porto AlegreUniversidade Federal de Ciências da Saúde de Porto AlegreUniversidade do Vale do Rio dos SinosUniversidade Federal do ParáUniversidade Federal do ParáLudus StudioUniversidade Federal do Rio Grande do SulUniversidade do Vale do Rio dos SinosUniversidade Federal de Ciências da Saúde de Porto AlegreAbstract Background Cardiovascular 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. Methods This 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. Discussion Anticipated 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 registration The 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).https://doi.org/10.1186/s13063-023-07747-6Exercise trainingExercise intensityMobile applicationsSedentary lifestyle |
| spellingShingle | Fernanda Laís Loro Riane Martins Cintia Laura Pereira de Araújo Lucio Rene Prade Denis Lima do Rosário Marcos César da Rocha Seruffo Italo Adriano Moraes de Freitas Jéferson Nobre Cristiano Bonato Both Pedro Dal Lago 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 Exercise training Exercise intensity Mobile applications Sedentary lifestyle |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Exercise training Exercise intensity Mobile applications Sedentary lifestyle |
| url | https://doi.org/10.1186/s13063-023-07747-6 |
| work_keys_str_mv | AT fernandalaisloro innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT rianemartins innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT cintialaurapereiradearaujo innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT lucioreneprade innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT denislimadorosario innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT marcoscesardarochaseruffo innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT italoadrianomoraesdefreitas innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT jefersonnobre innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT cristianobonatoboth innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial AT pedrodallago innovativeanddisruptivetechnologiestoprescribeencourageandevaluatephysicalexerciseinhealthyadultsaprotocolofexploratorystudyfollowedbyanoninferiorityinvestigatorblindedrandomizedclinicaltrial |