359ff62544cd30672304116654fcf6cd pmc_34200805.pdf d777465d8d9109732d263539fe6af03a4502cc26 pmc_34200805.pdf e7552ef6283d5f594aed1ad877fa2e119fa45215db18f3284c6fbfe7218346d3 pmc_34200805.pdf Title: Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial Subject: Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021. Keywords: depressive symptoms; exercise; personalised medicine; blended intervention; transdisciplinary Author: Aitana García-Estela, Natalia Angarita-Osorio, Sandra Alonso, Maria Polo, Maria Roldán-Berengué, Monique Messaggi-Sartor, Estanislao Mur-Mila, Laura Vargas-Puertolas, Víctor Pérez, Esther Duarte and Francesc Colom Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Thu Jun 10 13:42:09 2021 CEST ModDate: Thu Jun 10 13:56:19 2021 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 14 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 869071 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- QFFOGR+URWPalladioL-Ital Type 1 Custom yes yes no 10 0 GBBTSE+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 RHVMCY+URWPalladioL-Roma Type 1 Custom yes yes no 19 0 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LastModified: 2023-03-31 12:14:18 CEST Size: 869071 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 276 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Materials and Methods Destination: section.2 Children: Item: Title: Study Design Destination: subsection.2.1 Item: Title: Study Setting Destination: subsection.2.2 Item: Title: Eligibility Criteria Destination: subsection.2.3 Item: Title: Interventions Destination: subsection.2.4 Children: Item: Title: Intervention Description Destination: subsubsection.2.4.1 Item: Title: Application Development Destination: subsubsection.2.4.2 Item: Title: Criteria for Discontinuing or Modifying Allocated Interventions Destination: subsubsection.2.4.3 Item: Title: Strategies to Improve Adherence to Interventions Destination: subsubsection.2.4.4 Item: Title: Relevant Concomitant Care Permitted or Prohibited during the Trial Destination: subsubsection.2.4.5 Item: Title: Outcomes Destination: subsection.2.5 Children: Item: Title: Primary Outcome Measure Destination: subsubsection.2.5.1 Item: Title: Secondary Outcome Measures Destination: subsubsection.2.5.2 Item: Title: Sample Size Destination: subsection.2.6 Item: Title: Recruitment Destination: subsection.2.7 Item: Title: Assignment of Interventions: Allocation Destination: subsection.2.8 Item: Title: Concealment Mechanism Destination: subsection.2.9 Item: Title: Implementation Destination: subsection.2.10 Item: Title: Blinding Destination: subsection.2.11 Item: Title: Data Collection and Management Destination: subsection.2.12 Children: Item: Title: Plans for Assessment and Collection of Outcomes Destination: subsubsection.2.12.1 Item: Title: Plans to Promote Participant Retention and Complete Follow-Up Destination: subsubsection.2.12.2 Item: Title: Data Management Destination: subsubsection.2.12.3 Item: Title: Confidentiality Destination: subsubsection.2.12.4 Item: Title: Statistical Methods Destination: section.3 Children: Item: Title: Statistical Methods for Primary and Secondary Outcomes Destination: subsection.3.1 Item: Title: Methods in Analysis to Handle Protocol Non-Adherence and Any Statistical Methods to Handle Missing Data Destination: subsection.3.2 Item: Title: Ethics and Dissemination Destination: section.4 Item: Title: Trial Status Destination: section.5 Item: Title: Discussion and Conclusions Destination: section.6 Item: Title: References Destination: section.6 Info: Title: Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial Author: Aitana García-Estela, Natalia Angarita-Osorio, Sandra Alonso, Maria Polo, Maria Roldán-Berengué, Monique Messaggi-Sartor, Estanislao Mur-Mila, Laura Vargas-Puertolas, Víctor Pérez, Esther Duarte and Francesc Colom Subject: Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021. 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