NCT06825026

Brief Summary

This cohort of older adults residing in nursing homes in Porto Metropolitan Area aims to monitor the health, intrinsic capacity and functional capacity over time. Through systematic data collection and analysis, the observatory provides valuable insights into aging, frailty, and long-term care needs, informing policies and interventions to enhance older adults care. This cohort aims to recruit 400 individuals aged 65 years or more at baseline.All participants will be invited for a re-assessment every year, while the overall duration is planned for four years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 30, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

January 30, 2025

Last Update Submit

March 9, 2025

Conditions

Keywords

FrailNursing homes

Outcome Measures

Primary Outcomes (1)

  • short physical performance battery (SPPB)

    The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).

    4 years

Secondary Outcomes (5)

  • Handgrip strength

    4 years

  • Barthel Index

    4 years

  • Falls in the last 12 months

    4 years

  • Falls rate

    4 years

  • Frailty status

    4 years

Other Outcomes (4)

  • Times Using the Healthcare System in the Last 6 Months

    4 years

  • Mini Mental State Examination

    4 years

  • Mini Nutritional Assessment Short Form (MNA-SF)

    4 years

  • +1 more other outcomes

Interventions

As part of the broader Observatory of the Older Person cohort, we aim to conduct a pragmatic exercise trial in a subgroup of nursing home residents. This trial seeks to evaluate the effectiveness of a concurrent exercise intervention on frailty, functional capacity, independence in activities of daily living and falls rate in real-world settings.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals living in public nursing homes in Porto Metropolitan Area

You may qualify if:

  • Older adults aged 65 or older

You may not qualify if:

  • Any contraindication that could affect physical exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical condition;
  • bone fracture in the past 3 months;
  • Iinability to understand and follow the instructions of physical tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports, University of Porto

Porto, 4000, Portugal

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Joana Carvalho, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 13, 2025

Study Start

September 1, 2021

Primary Completion

October 1, 2021

Study Completion

December 31, 2024

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations