NCT06755645

Brief Summary

Lifestyle interventions can alleviate Parkinson's Disease (PD) symptoms and delay disease progression. The novelty of this project lies in the development of an innovative smart platform that utilizes artificial intelligence (AI) and predictive models to offer a groundbreaking solution that not only prevents disease progression but also significantly improves the well-being of patients with PD. For this, the technological smart platform will encompass 50 clinical variables, and a comprehensive range of other 50 supplementary variables, validated in a database with more than 1500 patients. The smart platform will include a user-friendly interface with different user profiles and a scalable back end with AI-based monitoring and prediction modules. This will offer primary prevention, early detection, and ongoing monitoring by specialized medical professionals at home and in hospitals.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

December 23, 2024

Last Update Submit

November 27, 2025

Conditions

Parkinson

Keywords

healthy habitsphysical activityartificial intelligencesmart platform

Outcome Measures

Primary Outcomes (1)

  • Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has a total score range of 0 to 236, with individual parts scoring between 0 to 52 (Parts I and II), 0 to 108 (Part III), and 0 to 24 (Part IV), assessing both motor and non-motor aspects of Parkinson's disease. A higher score indicates greater severity of Parkinson's disease symptoms.

    From enrollment (app download) to 1 year

Secondary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA)

    At enrollment (app download) and after 1 year

Study Arms (1)

Lifestyle intervention app

The group of patients includes individuals diagnosed with Parkinson's Disease (PD). This cohort encompasses a range of disease stages, severities, and demographic characteristics.

Other: Lifestyle intervention

Interventions

Lifestyle interventionOTHER

A technological smart platform (app) that integrates diets, physical activity programs, sleep habits and other lifestyle interventions

Lifestyle intervention app

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Parkinson's disease

You may qualify if:

  • Patients with Parkinson's disease

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon Llull University

Barcelona, 08022, Spain

Location

Related Publications (2)

  • Magana JC, Deus CM, Baldellou L, Avellanet M, Gea-Rodriguez E, Enriquez-Calzada S, Laguna A, Martinez-Vicente M, Hernandez-Vara J, Gine-Garriga M, Pereira SP, Montane J. Investigating the impact of physical activity on mitochondrial function in Parkinson's disease (PARKEX): Study protocol for A randomized controlled clinical trial. PLoS One. 2023 Nov 22;18(11):e0293774. doi: 10.1371/journal.pone.0293774. eCollection 2023.

    PMID: 37992028RESULT

  • Jossa-Bastidas O, Zahia S, Fuente-Vidal A, Sanchez Ferez N, Roda Noguera O, Montane J, Garcia-Zapirain B. Predicting Physical Exercise Adherence in Fitness Apps Using a Deep Learning Approach. Int J Environ Res Public Health. 2021 Oct 14;18(20):10769. doi: 10.3390/ijerph182010769.

    PMID: 34682515RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Joel Montane, PhD

CONTACT

0034932533256joelmm@blanquerna.url.edu

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 1, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations

ES(1)