NCT06094374

Brief Summary

Observational data from healthy adults aged 65+ will be collected through cross-sectional and longitudinal methods to analyze physical activity patterns, identifying digital phenotypes. Measurements include self-reports, clinical assessments, and EMA, with statistical analysis using multivariate regression and time series analysis, and a neural network if needed to find digital phenotypes related to physical activity in older adults.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

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

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

15 days

First QC Date

October 17, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Digital phenotypes of PA

    Patterns of physical activity behavior

    14 days

Study Arms (1)

Community Dwellling Healthy Older Adults

* 65 years or older * able to give informed consent * community dwelling * no severe illness (neurological, cardiovascular, respiratory, metabolic, cognitive disorder) * dutch language profiency

Behavioral: observation of physical activity behavior

Interventions

An observational study will be conducted to gather data on multiple levels aiming to identify diverse digital phenotypes related to PA behavior among community-dwelling older adults. A hybrid approach will be employed, combining both cross-sectional and longitudinal data collection methods. The overall aim is to employ data analysis to identify patterns of PA - behavior (referred to as phenotypes) and to pinpoint prognostic factors that affect PA outcomes. This integrated strategy will be complemented by four distinct measurement approaches, ensuring a comprehensive assessment of the research objectives. These measurement approaches include:self-reporting, clinical, ecological momentary and time series assessment.

Community Dwellling Healthy Older Adults

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Community Dwelling older adults aged 65 years or more

You may qualify if:

  • Participants are 65 years of older
  • Participants are competent to give informed consent
  • Participants are able to actively participate in the study
  • Participants are community-dwelling (living independent at home or in a service apartment)
  • Without a severe illness
  • Dutch language proficiency as native speaker

You may not qualify if:

  • Current neurological disorder such as Parkinson's disease, multiple sclerosis, cerebrovascular accident, …
  • Current cardiovascular disorder such as stroke, acute myocardial infarct, coronary artery bypass grafting, percutaneous coronary intervention less than 5 years ago
  • Current respiratory disorder, such as chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, asthma, …
  • Current severe metabolic disorder, such as diabetes type 1 and 2, severe osteoporosis, …
  • Current severe cognitive disorders, such as Alzheimer's disease, vascular dementia, Lewy Body dementia, frontotemporal dementia,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Daniels K, Vonck S, Robijns J, Spooren A, Hansen D, Bonnechere B. Characterising physical activity patterns in community-dwelling older adults using digital phenotyping: a 2-week observational study protocol. BMJ Open. 2025 May 24;15(5):e095769. doi: 10.1136/bmjopen-2024-095769.

Study Officials

  • Kim Daniels, MS

    PXL University College of Applied Sciences and Arts

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Daniels, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

January 15, 2024

Primary Completion

January 30, 2024

Study Completion

January 15, 2025

Last Updated

October 23, 2023

Record last verified: 2023-10