Old AgeActivOldNCT04732078
Physical and Mental Characteristics in Active Elderly People
An observational study of Old Age, run by University of Valencia at 1 site in Spain.
Trial summary
Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2021to 17 Apr 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active people over 60 years of age recruited from two associations from the city of Valencia, Spain will be part of the study.
Who may be able to join
- That they obtain in the IPAQ questionnaire on physical activity values belonging to category 2 (moderate level of physical activity) or 3 (high level of physical activity), that is, belonging to the group of ACTIVE people.
- That they are suitable in the Lobo Mini Cognitive Exam, with a score greater than or equal to 24 (with an adequate level of cognition, necessary to carry out the study).
- Meet the characteristics of "successful aging" (not having suffered in the last two years stroke or cerebrovascular accident, arteriosclerosis, angina, acute myocardial infarction, cancer, diabetes, chronic respiratory disease, chronic cardiovascular disease, neurological disease or psychological alteration).
Who cannot join
- Under 60 years not active according to the IPAQ
- Score less than 24 in the Lobo Mini Cognitive Exam (MEC),
- Those people who due to their physical condition cannot carry out the tests with guarantees of safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Mental Characteristics in Active Elderly People and Their Influence on Quality of Life
Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. The aim of this study is to describe an active population over 60 years old, which complies with the concept of successful aging, in order to know its characteristics both at a physical and mental health level and to be able to make recommendations from physiotherapy. Active people over 60 years of age recruited from two associations (Amics de la Nau Gran, and Hogares) from the city of Valencia, Spain will be part of the study.
Pain was assessed using the Visual Analogue Scale, the level of physical activity performed using the IPAQ questionnaire, quality of life using the SF-12v2, sleep quality using the Pittsburg questionnaire, and mood using the depression scale and Goldberg's anxiety, as well as functional tests to assess respiratory status.
Read the detailed description
Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. The practice of physical activity is rapidly becoming a constant among the population (as its many health benefits are becoming known) and increasingly among the elderly population. As there are no previous studies in our country that observe and relate different physical and mental aspects in older active population that complies with the concept of "successful aging", it has been decided to carry out this research to try to detect the benefits and deficiencies present in the condition health of people considered active and over 65 years. From the results obtained, recommendation strategies from physiotherapy can be defined and the effects that the practice of physical activity has on different aspects of the person's health will be shown. Our hypothesis of the present study is that active older people who frequently engage in physical activity have good mental and physical health, as well as good respiratory condition and quality of life.
Objective: Describe an active population over 60 years old, which complies with the concept of successful aging, in order to know its characteristics both at a physical and mental health level and to be able to make recommendations from physiotherapy.
In addition, analyze the state and the different respiratory variables in an active elderly population, know the state of mental health, detect signs related to anxiety or depression, know the quality and possible sleep disorders. Also analyze and relate physical health and mental health, and know the level of quality of life in this population group.
Material and methods Study design. Descriptive study developed at the University of Valencia. Participants. Active people over 60 years of age recruited from two associations from the city of Valencia, Spain will be part of the study.
Pain was assessed using the Visual Analogue Scale, the level of physical activity performed using the IPAQ questionnaire, quality of life using the SF-12v2, sleep quality using the Pittsburg questionnaire, and mood using the depression scale and Goldberg's anxiety, as well as functional tests to assess respiratory status.
- Conditions
- Old Age
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status
By the SF-12 Health Questionnaire (version 2). This questionnaire is an abbreviated version of the SF-36, with an approximate duration of 2 minutes and made up of 12 different items that address different physical and mental aspects of the person (physical role, emotional role, social role, physical function, mental health , limiting pain, vitality and general health). It uses the Likert scale and each item has different response options ranging from 3 to 6. The maximum score that can be obtained is 100 points.
Measured: day 1
Secondary outcomes (7)
Intensity of Pain
Visual Analog Scale. It is a commonly used and validated instrument in the interpretation of pain intensity. In a line of 10 cm, divided by numbers from 0 to 10, the patient marks the intensity of the pain, being 0 "absence of pain" and 10 "worst pain imaginable".
Measured: day 1
Mental State
By Minimental State Examination. It is made up of a set of items that are grouped into 5 groups or cognitive areas: orientation in space and time (2 items), fixation (1 item), concentration and calculation (2 items), memory (1 item), and language and construction (7 items). Throughout its completion it is important to speak clearly to the participants and in the event of a mistake not to correct them and to continue with the questionnaire. Each item is evaluated from 0 to 5, with 5 being the maximum score that can be achieved when the question is answered correctly. The maximum score of the exam is 35 points, being normal values: between 30 and 35 and indicating cognitive impairment scores below 24 (in people over 65) and below 28 (in people 65 years or less)
Measured: day 1
Level of Physical Activity
Physical activity was measured by the Short Form-International Physical Activity Questionnaire (s-IPAQ). The s-IPAQ contains seven items for identifying the frequency and duration of light, moderate, and vigorous physical activity as well as inactivity during the past week. The questions focus on four activity types: "vigorous activity" periods of at least 10 minutes, "moderate activity" periods of at least 10 minutes, "walking" periods of at least 10 minutes, and times spent "sitting" on weekdays. Frequency of activity is measured in days, and duration in hours and minutes. The patients were classified into three physical activity categories: low, moderate, and high. Typical s-IPAQ correlations with an accelerometer were 0.80 for reliability.
Measured: day 1
Sleep quality
Using the Pittsburg questionnaire (ICSP). It consists of 19 items or questions from which an overall score is obtained and which in turn are grouped into 7 different components (subjective sleep quality, latency, duration, sleep efficiency, sleep disturbances, use of medication and daytime dysfunction) . The total score will range from 0 to 21, with a higher score signifying a serious sleep problem. Values less than 5 indicate normality, values between 5 and 7 suggest medical attention, between 8 and 14 would be adequate medical attention and treatment, and a score greater than 15 is significant for a serious sleep problem.
Measured: day 1
Mood State
Goldberg depression and anxiety. It is a questionnaire that presents two scales, one for depression and the other for anxiety. Each one of these is made up of 4 initial items or questions to test and determine if there is a probability of the presence of one of these disorders, and another 5 items that are only formulated if the patient has answered affirmatively in the first 4. On the one hand, in the anxiety scale, the question is continued in the case of 2 or more affirmative answers in the first 4 questions, and in the depression scale, the questions are continued if there is any affirmative answer in the first 4 items. Regarding the final score, on the anxiety scale, 4 or more affirmative answers probably indicate an anxiety disorder, and on the depression scale 2 or more positive answers indicate a possible depressive disorder.
Measured: day 1
Exercise tolerance
6 Six Minute Walk Test (6MWT). The object of this test is to walk as far as possible for 6 minutes. The patient will walk back and forth around the cones in a hallway and is permitted to slow down, to stop, and to rest as necessary (but resume walking as soon as able)
Measured: day 1
Forced spirometry
Assessed using a COSMED PONY FX spirometer with mouthpiece and filters (1 cardboard mouthpiece and a bacteriological filter per patient). The test was performed with the person sitting, without crossing the legs and shoulders relaxed. Anthropometric data were entered into the equipment, nose was covered with a nose clio and the patient was then asked to perform three forced inhalations and exhalations.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start4 Feb 2021
- Primary completion30 Mar 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V Espí López, Dr, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732078
- Sponsor's protocol ID
- ID0032
- Acronym
- ActivOld
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2021
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Mental Characteristics in Active Elderly People and Their Influence on Quality of Life
- ClinicalTrials.gov ID
- NCT04732078
- Acronym / sponsor ID
- ActivOld / ID0032
- Conditions
- Old Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 1 Feb 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.
Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. The aim of this study is to describe an active population over 60 years old, which complies with the concept of successful aging, in order to know its characteristics both at a physical and mental health level and to be able to make recommendations from physiotherapy. Active people over 60 years of age recruited from two associations (Amics de la Nau Gran, and Hogares) from the city of Valencia, Spain will be part of the study.
Pain was assessed using the Visual Analogue Scale, the level of physical activity performed using the IPAQ questionnaire, quality of life using the SF-12v2, sleep quality using the Pittsburg questionnaire, and mood using the depression scale and Goldberg's anxiety, as well as functional tests to assess respiratory status.
Detailed description
Today's world is characterized among other things by a progressive increase in the aging population, due to a decrease in the birth rate and an increase in life expectancy. In developed countries, the number of older people is increasing, largely due to significant advances in health sciences and new life habits. The practice of physical activity is rapidly becoming a constant among the population (as its many health benefits are becoming known) and increasingly among the elderly population. As there are no previous studies in our country that observe and relate different physical and mental aspects in older active population that complies with the concept of "successful aging", it has been decided to carry out this research to try to detect the benefits and deficiencies present in the condition health of people considered active and over 65 years. From the results obtained, recommendation strategies from physiotherapy can be defined and the effects that the practice of physical activity has on different aspects of the person's health will be shown. Our hypothesis of the present study is that active older people who frequently engage in physical activity have good mental and physical health, as well as good respiratory condition and quality of life.
Objective: Describe an active population over 60 years old, which complies with the concept of successful aging, in order to know its characteristics both at a physical and mental health level and to be able to make recommendations from physiotherapy.
In addition, analyze the state and the different respiratory variables in an active elderly population, know the state of mental health, detect signs related to anxiety or depression, know the quality and possible sleep disorders. Also analyze and relate physical health and mental health, and know the level of quality of life in this population group.
Material and methods Study design. Descriptive study developed at the University of Valencia. Participants. Active people over 60 years of age recruited from two associations from the city of Valencia, Spain will be part of the study.
Pain was assessed using the Visual Analogue Scale, the level of physical activity performed using the IPAQ questionnaire, quality of life using the SF-12v2, sleep quality using the Pittsburg questionnaire, and mood using the depression scale and Goldberg's anxiety, as well as functional tests to assess respiratory status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active people over 60 years of age recruited from two associations from the city of Valencia, Spain will be part of the study.
Key inclusion criteria (3 listed)
- That they obtain in the IPAQ questionnaire on physical activity values belonging to category 2 (moderate level of physical activity) or 3 (high level of physical activity), that is, belonging to the group of ACTIVE people.
- That they are suitable in the Lobo Mini Cognitive Exam, with a score greater than or equal to 24 (with an adequate level of cognition, necessary to carry out the study).
- Meet the characteristics of "successful aging" (not having suffered in the last two years stroke or cerebrovascular accident, arteriosclerosis, angina, acute myocardial infarction, cancer, diabetes, chronic respiratory disease, chronic cardiovascular disease, neurological disease or psychological alteration).
Key exclusion criteria (3 listed)
- Under 60 years not active according to the IPAQ
- Score less than 24 in the Lobo Mini Cognitive Exam (MEC),
- Those people who due to their physical condition cannot carry out the tests with guarantees of safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health status
Time frame: day 1
By the SF-12 Health Questionnaire (version 2). This questionnaire is an abbreviated version of the SF-36, with an approximate duration of 2 minutes and made up of 12 different items that address different physical and mental aspects of the person (physical role, emotional role, social role, physical function, mental health , limiting pain, vitality and general health). It uses the Likert scale and each item has different response options ranging from 3 to 6. The maximum score that can be obtained is 100 points.
7 secondary outcomes
Intensity of Pain
Time frame: day 1
Mental State
Time frame: day 1
Level of Physical Activity
Time frame: day 1
Sleep quality
Time frame: day 1
Mood State
Time frame: day 1
Exercise tolerance
Time frame: day 1
Forced spirometry
Time frame: day 1
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 20 Feb 2024.
- 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.
Gemma V Espí López, Dr principal investigator
University of Valencia
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 Old Age, run by University of Valencia at 1 site 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 3 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 20 Feb 2024. 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 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?
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?
Health status (time frame: day 1). 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 20 Feb 2024.