Earlier Elderly People in Urban Areas

Physical Activity Clinical Trial

Official title:

Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05268146
• Other study ID #: Earlier-Elderly Urban People
• Status: Enrolling by invitation
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Lifestyle, Healthy
• Nutrition
• Physical Activity
• Sarcopenia
• Sleep

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