AgingNCT04250870
Physical Fitness in Elderly
A study testing Senior Fitness Test in people with Aging and Healthy Aging, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Aging decreases the physical fitness levels in living beings. The environmental factors also have a major effect on the physical fitness levels. The objective of this study was to compare the physical fitness levels of nursing home residents and community-dwelling elderly people. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Healthy Aging, Physical Fitness
- What is being tested?
- Senior Fitness Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2019to 3 Jan 2020
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged between 65 and 85 years
- Scored between 24 and 30 points in the Mini-Mental Status Examination (MMSE).
- Living in nursing homes for at least six months (for nursing home residents) (6,7).
Who cannot join
- Not able to communicate verbally
- Not able to stand for at least 90 seconds and ambulated with assistance
- Patients with severe visual impairment, neurological disorders and/or congestive heart failure
- Individuals who are not advised exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE PHYSICAL FITNESS LEVELS IN NURSING HOME RESIDENTS AND COMMUNITY DWELLING ELDERLY PEOPLE
Aging decreases the physical fitness levels in living beings. The environmental factors also have a major effect on the physical fitness levels. The objective of this study was to compare the physical fitness levels of nursing home residents and community-dwelling elderly people. This study employed 118 participants, who consisted of nursing home residents and community-dwelling elderly people. The physical fitness levels of the elderly people were measured by Senior Fitness Test. The physical fitness levels of the elderly people were measured by Senior Fitness Test. Chair stand test, arm curl test, 2-minute step test, chair sit and reach test, back-scratch test, 8-foot up and go test and body mass index were measured.
- Conditions
- Aging, Healthy Aging, Physical Fitness
- Being tested
- Senior Fitness Test
- Keywords
- aging, community dwelling, health, nursing homes, physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior Fitness TestDiagnostic test
Chair stand test:The number of full stands performed on a seated position that can be completed within 30 seconds was recorded.
Arm curl test: The participants were asked to lift weights starting with a full elbow extension and then full flexion.
2-minute step test: The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes.
Chair sit-and-reach test:The participant could extend right or left knee to a full extension, heel on the floor and ankle in a neutral position of 90 degrees. Then, the participant was asked to reach to the toes.
Back-scratch test:The participant was asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible.
8-foot up and go test:The participant was asked to get up from a chair without any arm support and walk a distance of 2.44 meters; then turn around a cone and come back to sit down on the chair.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Home Residents | Active comparator | Nursing home residents (n=59) were evaluated in five different nursing homes. Receives: Diagnostic Test: Senior Fitness Test |
| Community-Dwelling Elderly | Active comparator | The community-dwelling elderly people (n=59) were selected from two different municipalities of the city. Receives: Diagnostic Test: Senior Fitness Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-minute step test
The distance from the iliac crest to the midpoint of the patella was measured by a tape to determine the knee-stepping height. The midpoint of the distance between these two anatomical structures was determined. The height of the determined point from the ground was measured and marked on the wall. The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes. The total number of correct dominant side steps was recorded. If any of the participant's steps (right or left) did not reach the target height, those steps were considered invalid.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start5 Jan 2019
- Primary completion20 Dec 2019
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Yuruk, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250870
- Sponsor's protocol ID
- KA18/434
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 31 Jan 2020
- 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 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE PHYSICAL FITNESS LEVELS IN NURSING HOME RESIDENTS AND COMMUNITY DWELLING ELDERLY PEOPLE
- ClinicalTrials.gov ID
- NCT04250870
- Acronym / sponsor ID
- KA18/434
- Conditions
- Aging, Healthy Aging, Physical Fitness
- Keywords
- aging, community dwelling, health, nursing homes, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 31 Jan 2020 (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 decreases the physical fitness levels in living beings. The environmental factors also have a major effect on the physical fitness levels. The objective of this study was to compare the physical fitness levels of nursing home residents and community-dwelling elderly people. This study employed 118 participants, who consisted of nursing home residents and community-dwelling elderly people. The physical fitness levels of the elderly people were measured by Senior Fitness Test. The physical fitness levels of the elderly people were measured by Senior Fitness Test. Chair stand test, arm curl test, 2-minute step test, chair sit and reach test, back-scratch test, 8-foot up and go test and body mass index were measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nursing Home Residents | Active comparator | Diagnostic Test: Senior Fitness TestNursing home residents (n=59) were evaluated in five different nursing homes. |
| Community-Dwelling Elderly | Active comparator | Diagnostic Test: Senior Fitness TestThe community-dwelling elderly people (n=59) were selected from two different municipalities of the city. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged between 65 and 85 years
- Scored between 24 and 30 points in the Mini-Mental Status Examination (MMSE).
- Living in nursing homes for at least six months (for nursing home residents) (6,7).
Key exclusion criteria (4 listed)
- Not able to communicate verbally
- Not able to stand for at least 90 seconds and ambulated with assistance
- Patients with severe visual impairment, neurological disorders and/or congestive heart failure
- Individuals who are not advised exercise.
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 |
|---|---|---|
| Senior Fitness TestChair stand test:The number of full stands performed on a seated position that can be completed within 30 seconds was recorded. Arm curl test: The participants were asked to lift weights starting with a full elbow extension and then full flexion. 2-minute step test: The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes. Chair sit-and-reach test:The participant could extend right or left knee to a full extension, heel on the floor and ankle in a neutral position of 90 degrees. Then, the participant was asked to reach to the toes. Back-scratch test:The participant was asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible. 8-foot up and go test:The participant was asked to get up from a chair without any arm support and walk a distance of 2.44 meters; then turn around a cone and come back to sit down on the chair. | Diagnostic test | Community-Dwelling Elderly, Nursing Home Residents |
Primary outcome
2-minute step test
Time frame: 2 hours
The distance from the iliac crest to the midpoint of the patella was measured by a tape to determine the knee-stepping height. The midpoint of the distance between these two anatomical structures was determined. The height of the determined point from the ground was measured and marked on the wall. The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes. The total number of correct dominant side steps was recorded. If any of the participant's steps (right or left) did not reach the target height, those steps were considered invalid.
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 31 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior Fitness Test in people with Aging and Healthy Aging, run by Baskent 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 3 inclusion and 4 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 31 Jan 2020. 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?
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?
2-minute step test (time frame: 2 hours). 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 31 Jan 2020.