FrailtyNCT06825026
Observatory of the Older Person: A Cohort of Older Adults Living in Nursing Homes
An observational study of Frailty, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Pragmatic exercise trial
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Individuals living in public nursing homes in Porto Metropolitan Area
Who may be able to join
- Older adults aged 65 or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observatory of the Older Person: A Cohort of Older Adults Living in Nursing Homes in Porto Metropolitan Area
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.
- Conditions
- Frailty
- Being tested
- Pragmatic exercise trial
- Keywords
- Frail, Nursing homes
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pragmatic exercise trialBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (5)
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
Measured: 4 years
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)
Measured: 4 years
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
Measured: 4 years
Falls rate
A retrospective review of electronic medical records (EMRs) to identify athe number of falls reported within the last 12 months
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Sep 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Joana Carvalho, Universidade do Porto
- Investigators
- Maria Joana Carvalho, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825026
- Sponsor's protocol ID
- CEFADE012021_B
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of the Older Person: A Cohort of Older Adults Living in Nursing Homes in Porto Metropolitan Area
- ClinicalTrials.gov ID
- NCT06825026
- Acronym / sponsor ID
- CEFADE012021_B
- Conditions
- Frailty
- Keywords
- Frail, Nursing homes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Individuals living in public nursing homes in Porto Metropolitan Area
Key inclusion criteria (1 listed)
- Older adults aged 65 or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pragmatic exercise trialAs 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. | Behavioural | – |
Primary outcome
short physical performance battery (SPPB)
Time frame: 4 years
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).
5 secondary outcomes
Handgrip strength
Time frame: 4 years
Barthel Index
Time frame: 4 years
Falls in the last 12 months
Time frame: 4 years
Falls rate
Time frame: 4 years
Frailty status
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Joana Carvalho, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short physical performance battery (SPPB) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.