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CompletedNCT06825026Updated Mar 11, 2025

Observatory of the Older Person: A Cohort of Older Adults Living in Nursing Homes

An observational study in Frailty, sponsored by Universidade do Porto. Completed at 1 site in Portugal. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Universidade do Porto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
65 Years and older
Sex
All
01

Study 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.

Read the detailed description

The Observatory of the Older Person is a cohort study designed to enhance understanding of the aging process among older adults in nursing homes. The study aims to generate insights into the determinants of functional and intrinsic capacity, identify factors influencing independence, and develop targeted interventions to improve well-being in this population.

Specifically, it aims:

  • To provide a comprehensive characterization of the health profiles across nursing home population. This will include demographic, clinical, and functional assessments, as well as an exploration of variations in health conditions, nutritional status, cognitive function, and psychosocial well-being among residents.
  • to examine the trajectories of functional and intrinsic capacity over time by tracking changes in mobility, strength, balance, cognitive function, psychological resilience, and physiological health.
  • To determine the key factors contributing to the loss of independence in basic activities of daily living (ADLs). Physical, cognitive, psychological, and social determinants will be analyzed to identify their role in maintaining or reducing autonomy among nursing home residents.
  • To investigate the risk factors associated with falls in nursing home residents. Physical frailty, cognitive impairment, polypharmacy, and environmental hazards will be examined to determine their contribution to fall risk. Additionally, the consequences of falls, including injuries, hospitalizations, and fear of falling, will be assessed to evaluated.
  • To implement and assess the impact of exercise interventions designed to mitigate or reverse frailty. Tailored programs focusing on strength and endurance will be evaluated for their effectiveness in improving frailty status, reducing fall risk, and promoting autonomy among older adults.

By addressing these objectives, this study will contribute to evidence-based strategies for improving health, independence, and quality of life in nursing home residents.All participants will be invited for a re-assessment every year, while the overall duration is planned for four years. Findings may also inform policies and best practices to enhance care models within long-term care facilities.

02

Conditions studied

  • Frailty

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Keywords

  • Frail
  • Nursing homes
03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 400 is above the median of 223 across 496 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Individuals living in public nursing homes in Porto Metropolitan Area

Inclusion criteria

  • Older adults aged 65 or older

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Interventions

  • BehavioralPragmatic exercise trial

    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.

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What researchers measure

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).

    Time frame: 4 years

Secondary outcomes

  1. Handgrip strength

    Handgrip strength will be obtained with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA).Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 15s between trials

    Time frame: 4 years

  2. Barthel Index

    The Barthel Index (BI) is a standardized tool used to assess a person's ability to perform activities of daily living (ADLs) independently. It measures 10 basic functions, including feeding, bathing, dressing, toileting, mobility, and stair climbing, with scores ranging from 0 (fully dependent) to 100 (fully independent)

    Time frame: 4 years

  3. Falls in the last 12 months

    A retrospective review of electronic medical records (EMRs) to identify and document instances of falls reported within the last 12 months

    Time frame: 4 years

  4. Falls rate

    A retrospective review of electronic medical records (EMRs) to identify athe number of falls reported within the last 12 months

    Time frame: 4 years

  5. Frailty status

    The frailty phenotype is a clinical model that identifies frailty in older adults based on five criteria: unintentional weight loss, exhaustion, low physical activity, slow walking speed, and weak grip strength. Individuals meeting three or more criteria are classified as frail, two as pre-frail, and none as robust. It helps in identifying at-risk individuals for adverse outcomes and targeting interventions to prevent further decline.

    Time frame: 4 years

Other outcomes

  1. Times Using the Healthcare System in the Last 6 Months

    The number of healthcare encounters (e.g., hospital admissions, emergency department visits, outpatient consultations, and telehealth appointments) within the past six months

    Time frame: 4 years

  2. Mini Mental State Examination

    The Mini-Mental State Examination (MMSE) is a brief, structured tool used to assess cognitive function and screen for dementia. It consists of 30 questions covering areas such as orientation, memory, attention, language, and visuospatial skills. The MMSE is scored out of 30, with higher scores indicating better cognitive function. It is widely used in clinical settings to detect cognitive impairments, monitor changes in cognitive function over time, and assess the severity of cognitive decline. Scores are interpreted based on age and education level, with a lower score suggesting potential cognitive deficits.

    Time frame: 4 years

  3. Mini Nutritional Assessment Short Form (MNA-SF)

    The Mini Nutritional Assessment Short Form (MNA-SF) is a simplified version of the Mini Nutritional Assessment (MNA) designed to quickly assess the nutritional status of older adults. It consists of 6 questions, covering aspects such as weight loss, mobility, and food intake, which provide a quick screening for malnutrition risk. The MNA-SF is useful for identifying individuals who may be at risk of malnutrition and is often used in clinical settings for routine assessments. Based on the score, individuals are categorized as well-nourished, at risk of malnutrition, or malnourished, allowing for timely nutrition interventions.

    Time frame: 4 years

  4. Weight

    Assessment of body weight using Inbody 120, which is a body composition analyzer that uses bioelectrical impedance analysis (BIA).

    Time frame: 4 years

07

Study locations

1 site
  • Faculty of Sports, University of Porto
    Porto, 4000, Portugal
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06825026
Lead sponsor
Universidade do Porto
Responsible party
Maria Joana Carvalho (Principal Investigator, Universidade do Porto) — Principal investigator
First posted
Feb 13, 2025
Start date
Sep 1, 2021
Primary completion
Oct 1, 2021
Completion
Dec 31, 2024
Last update
Mar 11, 2025

Study contacts

Maria Joana Carvalho, PhD
principal investigator · Faculty of Sports, University of Porto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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