AgingPANGeA_MMNCT04899531
PANGeA - Physical Activity and Nutrition for Quality Ageing
An observational study of Aging and Sarcopenia, run by Science and Research Centre Koper at 1 site in Slovenia.
Trial summary
General objectives of the project Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the… Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Cognitive Decline
- What is being tested?
- Longitudinal observation
- How many people
- 950 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2013to 1 Apr 2023
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All males and females who participated in PANGeA mass measurements in 2013 will bi considered in the study.
Who may be able to join
- singed written consent
- age above 60
- healthy
Who cannot join
- severe musculoskeletal injuries
- inability to follow instructions when performing the test
Trial locations and contacts
1 site in 1 country.
Kaja Teraž, MSc contact
Slovenia1 site, 1 recruiting
- Recruiting
Science and research centre Koper
Koper, 6000
Kaja Teraž, Msc, +38641529226, kaja.teraz@zrs-kp.si
Matej KIeva, matej.kleva@zrs-kp.si
About this study
Official title: Longitudinal PANGeA Mass Measurement - Physical Activity and Nutrition for Quality Ageing
General objectives of the project
Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); Reducing the costs of health care; Connecting the existing health care, social and private entities and improving their mutual coordination.
Read the detailed description
Physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. The main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. The investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. The results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.
- Conditions
- Aging, Sarcopenia, Cognitive Decline
- Being tested
- Longitudinal observation
- Keywords
- elderly, longitudinal, physical activity, cognition, dietary habits
- Medical subject headings
- Sarcopenia, Cognitive Dysfunction, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal observationOther
No specific intervention, longitudinal (pre-post measurements) only
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal observation | No specific intervention, pre-post measurements only Receives: Other: Longitudinal observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Grip strength measured using a hand-held dynamometer
Measured: change in grip strength between two observational time points (pre-post 8-10years)
Secondary outcomes (1)
Gait speed
Gait speed measured for four meters self selected speed
Measured: change in gait speed between two observational time points (pre-post 8-10years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Apr 2013
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rado Pisot, Science and Research Centre Koper
- Investigators
- Rado Pišot, PhD, Study director, Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899531
- Sponsor's protocol ID
- PANGeA MM
- Acronym
- PANGeA_MM
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teraz K, Marusic U, Kalc M, Simunic B, Pori P, Grassi B, Lazzer S, Narici MV, Blenkus MG, di Prampero PE, Reggiani C, Passaro A, Biolo G, Gasparini M, Pisot R. Sarcopenia parameters in active older adults - an eight-year longitudinal study. BMC Public Health. 2023 May 19;23(1):917. doi: 10.1186/s12889-023-15734-4.
PubMed 37208654
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal PANGeA Mass Measurement - Physical Activity and Nutrition for Quality Ageing
- ClinicalTrials.gov ID
- NCT04899531
- Acronym / sponsor ID
- PANGeA_MM / PANGeA MM
- Conditions
- Aging, Sarcopenia, Cognitive Decline
- Keywords
- elderly, longitudinal, physical activity, cognition, dietary habits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 24 May 2021 (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.
General objectives of the project
Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); Reducing the costs of health care; Connecting the existing health care, social and private entities and improving their mutual coordination.
Detailed description
Physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. The main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. The investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. The results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal observation | – | Other: Longitudinal observationNo specific intervention, pre-post measurements only |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All males and females who participated in PANGeA mass measurements in 2013 will bi considered in the study.
Key inclusion criteria (3 listed)
- singed written consent
- age above 60
- healthy
Key exclusion criteria (2 listed)
- severe musculoskeletal injuries
- inability to follow instructions when performing the test
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 |
|---|---|---|
| Longitudinal observationNo specific intervention, longitudinal (pre-post measurements) only | Other | Longitudinal observation |
Primary outcome
Grip strength
Time frame: change in grip strength between two observational time points (pre-post 8-10years)
Grip strength measured using a hand-held dynamometer
1 secondary outcome
Gait speed
Time frame: change in gait speed between two observational time points (pre-post 8-10years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 37208654Teraz K, Marusic U, Kalc M, Simunic B, Pori P, Grassi B, Lazzer S, Narici MV, Blenkus MG, di Prampero PE, Reggiani C, Passaro A, Biolo G, Gasparini M, Pisot R. Sarcopenia parameters in active older adults - an eight-year longitudinal study. BMC Public Health. 2023 May 19;23(1):917. doi: 10.1186/s12889-023-15734-4.
- Individual participant dataSharing planned: Undecided
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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.
Kaja Teraž, MSc contact
Rado Pišot, PhD study director
Science and Research Centre Koper
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 Aging and Sarcopenia, run by Science and Research Centre Koper at 1 site in Slovenia.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 May 2021. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaja Teraž, MSc (kaja.teraz@zrs-kp.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: change in grip strength between two observational time points (pre-post 8-10years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899531, which also lists 1 linked publication.
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 25 May 2021.