Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05268146
Other study ID # Earlier-Elderly Urban People
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date March 31, 2022

Study information

Verified date March 2022
Source University Rovira i Virgili
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 77
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers
Gender All
Age group 60 Years to 74 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Failure to comply with the inclusion criteria will be considered an exclusion criterion.

Study Design


Intervention

Behavioral:
Lifestyles
Co-creation process and participatory research; lifestyles

Locations

Country Name City State
Spain Institut d'Investigació Sanitaria Pere i Virgili Reus Tarragona
Spain University Rovira i Virgili Reus Tarragona

Sponsors (1)

Lead Sponsor Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Age Age in years 1 day
Other Gender Female or male 1 day
Primary Risk of sarcopenia (muscle strength) Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer 1 day
Primary Diagnosis of sarcopenia (muscle strength) Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) 1 day
Primary Diagnosis of sarcopenia (muscle mass) Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance) 1 day
Primary Diagnosis of severe sarcopenia (muscle strength) Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and 1 day
Primary Diagnosis of severe sarcopenia (muscle mass) Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance) 1 day
Primary Diagnosis of severe sarcopenia (muscle function) Reduction of muscle function (=0.8 m / s) 1 day
Secondary Nutrition Food frequency questionnaire
(not scale)
1 day
Secondary 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).
1 day
Secondary 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.
1 day
Secondary Risk of malnutrition Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition 1 day
Secondary Weight Weight using a balance (kg) 1 day
Secondary height Height using a tallimeter (m) 1 day
Secondary BMI Using weight (kg) / height (m)2 1 day
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Active, not recruiting NCT03903874 - Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt N/A
Recruiting NCT03662438 - HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT) N/A
Withdrawn NCT04540523 - Home-Based Exergaming Intervention N/A
Recruiting NCT03250000 - Changes in Microcirculation and Functional Status During Exacerbation of COPD N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT05019482 - Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time N/A
Completed NCT03253406 - Health Wearables and College Student Health N/A
Not yet recruiting NCT05985460 - A Very Brief Intervention to Increase the Intention to Practice Physical Activity N/A
Completed NCT03700736 - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups N/A
Completed NCT03380143 - Whole-of-Community Youth Population Physical Activity N/A
Completed NCT03170921 - Psychophysiological Characterization of Different Capoeira Performances in Experienced Individuals N/A
Completed NCT04973813 - Active Choice Intervention About Physical Activity for Physically Inactive Adults N/A
Completed NCT03982095 - Survey on Lifestyle, Perceived Barriers and Development of Change in Patients With Prostate Cancer
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Completed NCT05670223 - Healthy Activities Improve Lives N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04578067 - Empowering Immigrant Women for Active and Healthy Lifestyle N/A
Completed NCT03297567 - Physical Therapy Guidelines For Hospitalized Elderly N/A