SarcopeniaNCT05268146
Earlier Elderly People in Urban Areas
An observational study of Sarcopenia and Eldery People, run by University Rovira i Virgili at 2 sites in Spain.
Trial summary
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Sarcopenia, Eldery People, Lifestyle, Healthy
- What is being tested?
- Lifestyles
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 77 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Feb 2022to 31 Mar 2022
- How long will I take part?
- 3 Days
- 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 74 years
- All sexes
- Adult, Older adult
Study population: Earlier elderly people living in urban areas. The target population will be recruited from different places in the community, town halls, civic centers, senior citizens' associations, etc.
Who may be able to join
- People ≥60 years and ≤75 years,
- That they have informed consent,
- Living at home (living independently), Community-dwelling early-elderly
- That they can continue the study,
- They live in the province of Tarragona
Who cannot join
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Institut d'Investigació Sanitaria Pere i Virgili
Reus, Tarragona, 43204
University Rovira i Virgili
Reus, Tarragona
About this study
Official title: Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment.
Read the detailed description
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. For the first time in history, most people can aspire to live well beyond the age of 60. On the other hand, the Covid-19 pandemic has severely affected people ≥60 years of age and may make the welfare and health problems of this population more evident, such as unhealthy lifestyles, the risk of malnutrition, and sarcopenia (defined as loss of muscle mass, strength, and function), which leads to significant dependency and quality of life problems. In addition, older people living in urban areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from urban areas in the generation of solutions, which will make these solutions especially adapted to their needs. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment. During the co-creation process, the elderly and the 4-helix stakeholders (government, industry, university, and civil society) will be involved.
- Conditions
- Sarcopenia, Eldery People, Lifestyle, Healthy, Nutrition, Sleep, Physical Activity
- Being tested
- Lifestyles
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestylesBehavioural
Co-creation process and participatory research; lifestyles
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of sarcopenia (muscle strength)
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Measured: 1 day
Diagnosis of sarcopenia (muscle strength)
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Measured: 1 day
Diagnosis of sarcopenia (muscle mass)
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Measured: 1 day
Diagnosis of severe sarcopenia (muscle strength)
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and
Measured: 1 day
Diagnosis of severe sarcopenia (muscle mass)
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Measured: 1 day
Diagnosis of severe sarcopenia (muscle function)
Reduction of muscle function (≤0.8 m / s)
Measured: 1 day
Secondary outcomes (7)
Nutrition
Food frequency questionnaire
(not scale)
Measured: 1 day
Physical activity
International physical activity questionnaire for elderly Low category: non-physical activity or it is not enough to achieve moderate or high category Moderate category: 3 or more days / weeks (vigorous physical activity, at least 25 minutes/day), or 5 or more (moderate physical activity, at least 30 minutes/day), or 5 or more days / weeks of a combination of walking, or moderate-vigorous physical activity (at least 600 METS).
High category: 7 or more days / week of a combination of walking, or moderate-vigorous physical activity (at least 3000 METS).
Measured: 1 day
Sleep behaviour
Pittsburg questionnaire
Pittsburg questionnaire The questionnaire contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The score of the seven areas is finally added to give an overall score, which ranges from 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.
Measured: 1 day
Risk of malnutrition
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
Measured: 1 day
Weight
Weight using a balance (kg)
Measured: 1 day
height
Height using a tallimeter (m)
Measured: 1 day
BMI
Using weight (kg) / height (m)2
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Feb 2022
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Rosa Sola, Dr, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268146
- Sponsor's protocol ID
- Earlier-Elderly Urban People
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas
- ClinicalTrials.gov ID
- NCT05268146
- Acronym / sponsor ID
- Earlier-Elderly Urban People
- Conditions
- Sarcopenia, Eldery People, Lifestyle, Healthy, Nutrition, Sleep, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 7 Mar 2022 (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.
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment.
Detailed description
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. For the first time in history, most people can aspire to live well beyond the age of 60. On the other hand, the Covid-19 pandemic has severely affected people ≥60 years of age and may make the welfare and health problems of this population more evident, such as unhealthy lifestyles, the risk of malnutrition, and sarcopenia (defined as loss of muscle mass, strength, and function), which leads to significant dependency and quality of life problems. In addition, older people living in urban areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from urban areas in the generation of solutions, which will make these solutions especially adapted to their needs. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment. During the co-creation process, the elderly and the 4-helix stakeholders (government, industry, university, and civil society) will be involved.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Earlier elderly people living in urban areas. The target population will be recruited from different places in the community, town halls, civic centers, senior citizens' associations, etc.
Key inclusion criteria (5 listed)
- People ≥60 years and ≤75 years,
- That they have informed consent,
- Living at home (living independently), Community-dwelling early-elderly
- That they can continue the study,
- They live in the province of Tarragona
Key exclusion criteria (1 listed)
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
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 |
|---|---|---|
| LifestylesCo-creation process and participatory research; lifestyles | Behavioural | – |
Primary outcome
Risk of sarcopenia (muscle strength)
Time frame: 1 day
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Diagnosis of sarcopenia (muscle strength)
Time frame: 1 day
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Diagnosis of sarcopenia (muscle mass)
Time frame: 1 day
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle strength)
Time frame: 1 day
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and
Diagnosis of severe sarcopenia (muscle mass)
Time frame: 1 day
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle function)
Time frame: 1 day
Reduction of muscle function (≤0.8 m / s)
7 secondary outcomes
Nutrition
Time frame: 1 day
Physical activity
Time frame: 1 day
Sleep behaviour
Time frame: 1 day
Risk of malnutrition
Time frame: 1 day
Weight
Time frame: 1 day
height
Time frame: 1 day
BMI
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Rosa Sola, Dr principal investigator
University Rovira i Virgili
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Eldery People, run by University Rovira i Virgili at 2 sites in Spain.
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 5 inclusion and 1 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
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?
Risk of sarcopenia (muscle strength) (time frame: 1 day). The study lists 6 primary outcomes in all. 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 31 Mar 2022.