Healthy AgingNCT05022966
The Relationship Between Physical Activity and Falling Risk and Fear of Falling in Elderlies
An observational study of Healthy Aging, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Aging is a physiological process, and it is a picture in which a decrease in physical functions, regression in cognitive abilities, decrease in social activities, loss of functionality in their lives occur and these are accompanied by many health problems. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Healthy Aging
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2021to Aug 2022
- 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 90 years
- All sexes
- Adult, Older adult
Study population: The study group of this research is planned to be composed of residents of Melmira Elderly Care Center and Nursing Home.
Who may be able to join
- Volunteering to participate in the research
- Being 60 years old or older
- Staying in a nursing home for at least 1 month
- Independent mobilization of the participants
Who cannot join
- Having a problem that prevents communication
- Having multiple comorbidities
- Having a cognitive problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kadirhan Ozdemir
Izmir, 06580
Kadirhan Ozdemir, 05069439059, kadirhanozdemir@gmail.com
About this study
Aging is a physiological process, and it is a picture in which a decrease in physical functions, regression in cognitive abilities, decrease in social activities, loss of functionality in their lives occur and these are accompanied by many health problems. As a result of the changes in the human body and mind, the productivity of the organism and the ability of the person to adapt to the environment decrease. According to the data of the World Health Organization, this period is considered to be 65 years and over, and according to the data of the United Nations, 60 years and over.
The aim of this study is to investigate the effect of physical activity level on activities of daily living and fear of falling in elderlies.
Read the detailed description
Physical activity is defined as voluntary movements produced by skeletal muscles that result in increased energy expenditure. Physical activity includes activities that are done as a part of daily life. One of the protective factors against mental and physical diseases in old age is physical activity. There is a linear and strong link between physical activity and health. Physical inactivity accounts for 6% of deaths worldwide and ranks fourth among risk factors. Being physically active has an important place in the protection and development of health, active healthy aging, and protection from diseases caused by inactivity.
Activities of daily living are essential and important vital functions for a healthy or sick individual to survive. The most important wishes of aging individuals are to be able to perform daily living activities such as walking, climbing stairs, and getting up without the need for help. The activities of daily living of the elderly are reduced or prevented, and they begin to lose their independence.
Fear of falling, which is frequently encountered in the elderly, is among the psychological consequences of falling. Fear of falling, which is defined as avoidance of activity or fear of falling leading to decreased activity, is seen in 35-55% of the elderly. Falls are among the most common causes of morbidity and mortality in the elderly. One-third of people over the age of 65 fall each year, and half of the falls are recurrent falls. Depending on the fear of falling, the physical activities of the elderly may be restricted.
- Conditions
- Healthy Aging
- Being tested
- No intervention
- Keywords
- Physical activity, Daily life activities, Fear of falling
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Individuals did not received any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Older people | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Scale For Elderly
Physical Activity Scale For Elderly (PASE) includes participants' walking, mild, moderate, vigorous sports and recreational activities, muscle strength and endurance exercises, work-related activities including walking and standing, lawn and garden maintenance, caring for another person, home repairs, heavy-duty sports and recreational activities in the past week. Home and work-related activities are scored as yes or no. For work-related activities, paid or unpaid work is scored in hours per week. The total PASE score is calculated by multiplying the time spent in each activity (hours per week) or participation in an activity (ie yes or no) by the experimentally derived item weights, and then adding the overall activities. The overall PASE score ranges from 0 to 400 or more, with higher scores indicating better levels of physical activity.
Measured: At baseline
Modified Barthel Index
Modified Barthel Index is a 10-item scale that evaluates physical independence in activities of daily living (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). The total score (0-100) is calculated by scoring each item separately with a three-digit scoring system. The total score ranges from 0 to 100, where "0" indicates complete dependency and "100" indicates complete independence. The sensitivity of the index was increased by using a five-step scoring system in the Modified Barthel index modified by Shah.
Measured: At baseline
Falls Efficacy Scale International
Fall Effectiveness Scale-International (FES-I), developed and approved by the European Fall Prevention Network (ProFaNE), has become a widely accepted tool for assessing fall anxiety. The FES-I is a self-reported questionnaire that provides information on the level of anxiety about falls for a range of activities of daily living. The original questionnaire contains 16 items scored on a four-point scale (1 = not at all interested to 4 = very interested). The lowest score that can be obtained from the survey is 16 and the highest score is 64. A high score indicates an increased level of anxiety. The Turkish validity and reliability of the questionnaire was performed by Ulus et al.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start30 Aug 2021
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadirhan Ozdemir, PT, PhD., Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022966
- Sponsor's protocol ID
- 2021-06-277
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2021
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical Activity and Falling Risk and Fear of Falling in Elderlies
- ClinicalTrials.gov ID
- NCT05022966
- Acronym / sponsor ID
- 2021-06-277
- Conditions
- Healthy Aging
- Keywords
- Physical activity, Daily life activities, Fear of falling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Aug 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.
Aging is a physiological process, and it is a picture in which a decrease in physical functions, regression in cognitive abilities, decrease in social activities, loss of functionality in their lives occur and these are accompanied by many health problems. As a result of the changes in the human body and mind, the productivity of the organism and the ability of the person to adapt to the environment decrease. According to the data of the World Health Organization, this period is considered to be 65 years and over, and according to the data of the United Nations, 60 years and over.
The aim of this study is to investigate the effect of physical activity level on activities of daily living and fear of falling in elderlies.
Detailed description
Physical activity is defined as voluntary movements produced by skeletal muscles that result in increased energy expenditure. Physical activity includes activities that are done as a part of daily life. One of the protective factors against mental and physical diseases in old age is physical activity. There is a linear and strong link between physical activity and health. Physical inactivity accounts for 6% of deaths worldwide and ranks fourth among risk factors. Being physically active has an important place in the protection and development of health, active healthy aging, and protection from diseases caused by inactivity.
Activities of daily living are essential and important vital functions for a healthy or sick individual to survive. The most important wishes of aging individuals are to be able to perform daily living activities such as walking, climbing stairs, and getting up without the need for help. The activities of daily living of the elderly are reduced or prevented, and they begin to lose their independence.
Fear of falling, which is frequently encountered in the elderly, is among the psychological consequences of falling. Fear of falling, which is defined as avoidance of activity or fear of falling leading to decreased activity, is seen in 35-55% of the elderly. Falls are among the most common causes of morbidity and mortality in the elderly. One-third of people over the age of 65 fall each year, and half of the falls are recurrent falls. Depending on the fear of falling, the physical activities of the elderly may be restricted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older people | – | Other: No intervention |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study group of this research is planned to be composed of residents of Melmira Elderly Care Center and Nursing Home.
Key inclusion criteria (4 listed)
- Volunteering to participate in the research
- Being 60 years old or older
- Staying in a nursing home for at least 1 month
- Independent mobilization of the participants
Key exclusion criteria (3 listed)
- Having a problem that prevents communication
- Having multiple comorbidities
- Having a cognitive problem
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 |
|---|---|---|
| No interventionIndividuals did not received any intervention. | Other | Older people |
Primary outcome
Physical Activity Scale For Elderly
Time frame: At baseline
Physical Activity Scale For Elderly (PASE) includes participants' walking, mild, moderate, vigorous sports and recreational activities, muscle strength and endurance exercises, work-related activities including walking and standing, lawn and garden maintenance, caring for another person, home repairs, heavy-duty sports and recreational activities in the past week. Home and work-related activities are scored as yes or no. For work-related activities, paid or unpaid work is scored in hours per week. The total PASE score is calculated by multiplying the time spent in each activity (hours per week) or participation in an activity (ie yes or no) by the experimentally derived item weights, and then adding the overall activities. The overall PASE score ranges from 0 to 400 or more, with higher scores indicating better levels of physical activity.
Modified Barthel Index
Time frame: At baseline
Modified Barthel Index is a 10-item scale that evaluates physical independence in activities of daily living (transfer, ambulation/wheelchair use, stair climbing, feeding, dressing, self-regulation, bathing, toilet use, urinary continence, stool continence). The total score (0-100) is calculated by scoring each item separately with a three-digit scoring system. The total score ranges from 0 to 100, where "0" indicates complete dependency and "100" indicates complete independence. The sensitivity of the index was increased by using a five-step scoring system in the Modified Barthel index modified by Shah.
Falls Efficacy Scale International
Time frame: At baseline
Fall Effectiveness Scale-International (FES-I), developed and approved by the European Fall Prevention Network (ProFaNE), has become a widely accepted tool for assessing fall anxiety. The FES-I is a self-reported questionnaire that provides information on the level of anxiety about falls for a range of activities of daily living. The original questionnaire contains 16 items scored on a four-point scale (1 = not at all interested to 4 = very interested). The lowest score that can be obtained from the survey is 16 and the highest score is 64. A high score indicates an increased level of anxiety. The Turkish validity and reliability of the questionnaire was performed by Ulus et al.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- 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.
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 Healthy Aging, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 4 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: status not confirmed, as of the sponsor's last update on 16 Sep 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Scale For Elderly (time frame: At baseline). The study lists 3 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 16 Sep 2021.