Old Age; AtrophyNCT05609851
Relationship Occupation and Physical Performance in Elderly
An observational study of Old Age; Atrophy and Elderly, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Atrophy, Elderly, Occupational Balance
- What is being tested?
- Short Physical Performance Batary and Occupational Balance Self-Assessment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2022to 31 Dec 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Volunteers aged 65 and over older adults.
Who may be able to join
- Volunteers aged 65 and over will be included.
Who cannot join
- Having visual-hearing loss that prevents them from making evaluations,
- Individuals with poor co-operation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tuba Maden
Gaziantep
tuba maden, PhD, 05319340249, tuba.kmaden@gmail.com
About this study
Official title: The Relationship of Physical Performance With Perceived Occupational Competence and Value in Elderly
Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Balance and falling losses can also affect occupation. Our study was conducted to examine the relationship between physical performance and occupational balance in elderly individuals. According to the power analysis, it is planned to include the individual in the study. Individuals will only be evaluated and the relationship between scale results will be analyzed statistically.
- Being tested
- Short Physical Performance Batary, Occupational Balance Self-Assessment
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Physical Performance BataryOther
The SPPB includes usual walking speed over 4 m, five chair-stands test, and balance test. A score (scale: 0-4) was assigned to performance on time to rise five times from a seated position, standing balance, and 4-m walking velocity. Individuals received a score of 0 for each task they were unable to complete. Participants coded in the "unable to perform" category included (a) those who tried but were unable and (b) the interviewer or participant felt it was unsafe. Summing the three individual categorical scores, a summary performance score was created for each participant (range: 0-12), with higher scores indicating better lower body function.
Occupational Balance Self-AssessmentOther
The Occupational Self-Assessment (OSA) is a self-reported assessment tool consisting of 21 items in which the patient rates their occupational competence (i.e., how well they do) and value (i.e., how important it is to them). The first 11 items are related to skills and occupational performance, the next five items concern habitation (including habits and roles), and the last five items correspond to volition (including personal causation, values, and interests). In the OSA, each item is scored on two separate 4-point scales, one for occupational competence (1 = I have a lot of problems doing this; 4 = I do this extremely well) and the other for value (1 = This is not important to me; 4 = This is most important to me).
The individual item scores are summed to obtain separate total scores for competence and value. Higher total scores indicate higher occupational competence and value.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | A physical performance test will be applied to the group and Questionnaires related to occupation will be made to individuals. Receives: Other: Short Physical Performance Batary; Other: Occupational Balance Self-Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSA
The Occupational Self-Assessment (OSA) is a self-reported assessment tool consisting of 21 items in which the patient rates their occupational competence (i.e., how well they do) and value (i.e., how important it is to them). The first 11 items are related to skills and occupational performance, the next five items concern habitation (including habits and roles), and the last five items correspond to volition (including personal causation, values, and interests). In the OSA, each item is scored on two separate 4-point scales, one for occupational competence (1 = I have a lot of problems doing this; 4 = I do this extremely well) and the other for value (1 = This is not important to me; 4 = This is most important to me).
The individual item scores are summed to obtain separate total scores for competence and value. Higher total scores indicate higher occupational competence and value.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start14 Nov 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; AtrophyStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogr Uyesi Tuba MADEN, University of Gaziantep
- Investigators
- tuba maden, PhD, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609851
- Sponsor's protocol ID
- 2020/280
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Physical Performance With Perceived Occupational Competence and Value in Elderly
- ClinicalTrials.gov ID
- NCT05609851
- Acronym / sponsor ID
- 2020/280
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 14 Nov 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Nov 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.
Occupational competence indicates participating in a variety of occupations to meet the standards expected of the individuals' valued roles to sustain a pattern of occupational attitudes that is significant and satisfying. Physical performance declines with age. This causes problems with balance and falling. Balance and falling losses can also affect occupation. Our study was conducted to examine the relationship between physical performance and occupational balance in elderly individuals. According to the power analysis, it is planned to include the individual in the study. Individuals will only be evaluated and the relationship between scale results will be analyzed statistically.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Other: Short Physical Performance Batary, Other: Occupational Balance Self-AssessmentA physical performance test will be applied to the group and Questionnaires related to occupation will be made to individuals. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Volunteers aged 65 and over older adults.
Key inclusion criteria (1 listed)
- Volunteers aged 65 and over will be included.
Key exclusion criteria (2 listed)
- Having visual-hearing loss that prevents them from making evaluations,
- Individuals with poor co-operation will be excluded from the study.
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 |
|---|---|---|
| Short Physical Performance BataryThe SPPB includes usual walking speed over 4 m, five chair-stands test, and balance test. A score (scale: 0-4) was assigned to performance on time to rise five times from a seated position, standing balance, and 4-m walking velocity. Individuals received a score of 0 for each task they were unable to complete. Participants coded in the "unable to perform" category included (a) those who tried but were unable and (b) the interviewer or participant felt it was unsafe. Summing the three individual categorical scores, a summary performance score was created for each participant (range: 0-12), with higher scores indicating better lower body function. | Other | experimental group |
| Occupational Balance Self-AssessmentThe Occupational Self-Assessment (OSA) is a self-reported assessment tool consisting of 21 items in which the patient rates their occupational competence (i.e., how well they do) and value (i.e., how important it is to them). The first 11 items are related to skills and occupational performance, the next five items concern habitation (including habits and roles), and the last five items correspond to volition (including personal causation, values, and interests). In the OSA, each item is scored on two separate 4-point scales, one for occupational competence (1 = I have a lot of problems doing this; 4 = I do this extremely well) and the other for value (1 = This is not important to me; 4 = This is most important to me). The individual item scores are summed to obtain separate total scores for competence and value. Higher total scores indicate higher occupational competence and value. | Other | experimental group |
Primary outcome
OSA
Time frame: through study completion, an average of one month
The Occupational Self-Assessment (OSA) is a self-reported assessment tool consisting of 21 items in which the patient rates their occupational competence (i.e., how well they do) and value (i.e., how important it is to them). The first 11 items are related to skills and occupational performance, the next five items concern habitation (including habits and roles), and the last five items correspond to volition (including personal causation, values, and interests). In the OSA, each item is scored on two separate 4-point scales, one for occupational competence (1 = I have a lot of problems doing this; 4 = I do this extremely well) and the other for value (1 = This is not important to me; 4 = This is most important to me). The individual item scores are summed to obtain separate total scores for competence and value. Higher total scores indicate higher occupational competence and value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
tuba maden, PhD principal investigator
University of Gaziantep
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; Atrophy and Elderly, run by University of Gaziantep 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 1 inclusion and 2 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 8 Nov 2022. 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?
Contact tuba maden, PhD (05319340249, tuba.kmaden@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSA (time frame: through study completion, an average of one month). 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 8 Nov 2022.