Mobile Application-delivered Resistance Program for Children and Adolescents With Type 1 Diabetes (Diactive-1)
NCT ID: NCT06048757
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2023-08-20
2024-10-01
Brief Summary
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Detailed Description
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To achieve this objective, researchers will conduct a 24 weeks randomized controlled trial involving at least 52 participants diagnosed with type 1 diabetes. The study will consist of two groups: an experimental group utilizing the Diactive-1 application and a control group receiving standard treatment. Participant allocation to either group will be determined through central randomization.
The Diactive-1 intervention encompasses several key features, including: (i) tailoring exercises based on initial physical fitness levels; (ii) adjusting the previous exercise to the glucose level measured through an interstitial glucose monitor or entered manually before the training session; (iii) monitoring heart rate during exercise; (iv) providing the flexibility to train with or without equipment, individually or with a partner; (v) dispensing diabetes management advice before and after each training session; and (vi) adapting training progressions based on session adherence. A face-to-face session will be conducted before commencing the intervention to ensure that participants are familiar with the fundamental movements, thus reducing the risk of potential muscle injuries.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental app intervention group
The intervention in the experimental group will center around the use of a mobile application (i.e., device), namely the Diactive-1 app.
Diactive-1 application
Participants will engage in 24 weeks resistance exercise program with goal of maintaining at least 3 sessions per week with 4-5 exercises per session (13-33 minutes). The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper and lower body and the core, utilizing the participants' body weight as the primary resistance or auxiliary materials such as elastic bands and a water-fillable kettlebell. The load and intensity of the exercise will be based on the number of repetitions, the resistance of the elastic bands and/or the weight of the aquaball, as well as the difficulty of the exercises. A mobile application known as Diactive-1 will be utilized.
Waiting-list control group
This arm will not complete an intervention. Participants will be instructed to continue to follow their normal daily diabetes care plan (i.e., standard care). This group will be granted access to the app following the intervention.
No interventions assigned to this group
Interventions
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Diactive-1 application
Participants will engage in 24 weeks resistance exercise program with goal of maintaining at least 3 sessions per week with 4-5 exercises per session (13-33 minutes). The training intervention will comprise 3-4 sets of 6-12 repetitions and will consist of a combination of exercises for the upper and lower body and the core, utilizing the participants' body weight as the primary resistance or auxiliary materials such as elastic bands and a water-fillable kettlebell. The load and intensity of the exercise will be based on the number of repetitions, the resistance of the elastic bands and/or the weight of the aquaball, as well as the difficulty of the exercises. A mobile application known as Diactive-1 will be utilized.
Eligibility Criteria
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Inclusion Criteria
* At least 6 months post-diagnosis for type 1 diabetes
* Ability to complete measures and intervention program in Spanish
* Access to broadband or cellular internet
* Patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.
Exclusion Criteria
* Participants will be excluded if they don't have access to the internet, lack a smartphone or tablet, or are unable to use the application.
8 Years
18 Years
ALL
No
Sponsors
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Complejo Hospitalario de Navarra
OTHER
Universidad Pública de Navarra
OTHER
Fundacion Miguel Servet
OTHER
Responsible Party
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Principal Investigators
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Antonio García-Hermoso, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación Miguel Servet - Navarrabiomed
Locations
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Fundación Miguel Servet/ Navarrabiomed
Pamplona, Navarre, Spain
Paediatric Endocrinology Unit at Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Countries
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References
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Hormazabal-Aguayo I, Munoz-Pardeza J, Lopez-Gil JF, Huerta-Uribe N, Chueca-Guindulain MJ, Berrade-Zubiri S, Burillo Sanchez E, Izquierdo M, Ezzatvar Y, Garcia-Hermoso A. Comprehensive management of children and adolescents with type 1 diabetes mellitus through personalized physical exercise and education using an mHealth system: The Diactive-1 study protocol. Front Endocrinol (Lausanne). 2024 Feb 6;15:1354734. doi: 10.3389/fendo.2024.1354734. eCollection 2024.
Related Links
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Related Info
Other Identifiers
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AGH_Diactive1_2023
Identifier Type: -
Identifier Source: org_study_id