Old Age; DebilityNCT05758792
Muscle Quality, Fall Concern and Lower Extremity Functionality in Older Women
An observational study of Old Age; Debility and Age-Related Sarcopenia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Old Age; Debility, Age-Related Sarcopenia
- What is being tested?
- Muscle Quality Index
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 26 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 65 to 85 years
- All sexes
- Older adult
Study population: Age-matched older men and women were included in the study.
Who may be able to join
- Being 65 years old or older
- Having no neurological, orthopedic, communicational,
- Mental disability that affects the evaluations.
Who cannot join
- Incomplete data and older adults not agreeing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20160
About this study
Official title: Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?
The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.
Read the detailed description
The effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. The aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. The muscle quality Index, fear of fall, and lower extremity functionality were evaluated. The results of older women and men were compared.
- Conditions
- Old Age; Debility, Age-Related Sarcopenia
- Being tested
- Muscle Quality Index
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Quality IndexOther
Also called Lower Extremity Functional Scale, International Fall Efficiency Scale
Evaluations are applied to older adults to compare the results of muscle quality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Quality Index
Muscle Quality Index scored is calculated through anthropometric measurements of older adults. The muscle quality depends on the formula as follows: MQI (Watts) = ((Leg length×0.4)×Body mass×gravity ×10)/ Five Times Sit To Stand.
Measured: 6 months
Lower Extremity Functional Scale
LEFS presents 20 questions about daily living activities. The questionnaire was developed to assess lower extremity functionality and can be used in older adults.The minimum and maximum total score ranges from 0 to 80. High scores show high functional status.
Measured: 6 months
International Fall Efficiency Scale
The scale consist of items about fall concern during daily living activities. The minimum and maximum total score ranges from 16 to 64. High scores represents high fall concern.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start20 Jan 2021
- Primary completion30 Aug 2021
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies 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
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
- Investigators
- Güzin Kara Çakıcı, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758792
- Sponsor's protocol ID
- 60116787-020/71654
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data.
Publications
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Fragala MS, Fukuda DH, Stout JR, Townsend JR, Emerson NS, Boone CH, Beyer KS, Oliveira LP, Hoffman JR. Muscle quality index improves with resistance exercise training in older adults. Exp Gerontol. 2014 May;53:1-6. doi: 10.1016/j.exger.2014.01.027. Epub 2014 Feb 6.
PubMed 24508922Gadelha AB, Neri SGR, Nobrega OT, Pereira JC, Bottaro M, Fonseca A, Lima RM. Muscle quality is associated with dynamic balance, fear of falling, and falls in older women. Exp Gerontol. 2018 Apr;104:1-6. doi: 10.1016/j.exger.2018.01.003. Epub 2018 Jan 9. No abstract available.
PubMed 29329971
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Poor Muscle Quality in Older Women Affect Fall Concern and Lower Extremity Functionality?
- ClinicalTrials.gov ID
- NCT05758792
- Acronym / sponsor ID
- 60116787-020/71654
- Conditions
- Old Age; Debility, Age-Related Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 7 Mar 2023 (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.
The aim of the study was to investigate the effects of muscle quality on fear of fall, and lower extremity functionality in older women. The differences between muscle quality, fear of falling and lower extremity functionality in the elderly male and female participating in the study were investigated. Older women had worse muscle quality, higher fall concern and less lower extremity functionality than older men.
Detailed description
The effects of muscle quality and lower extremity functionality, and fear of falling in older women are not well-known compared to older men in the same age group. The aim of the study was to investigate the effects of muscle quality on lower extremity functionality and fear of falling in older women. 168 age-matched older adults participated in the study. The muscle quality Index, fear of fall, and lower extremity functionality were evaluated. The results of older women and men were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Age-matched older men and women were included in the study.
Key inclusion criteria (3 listed)
- Being 65 years old or older
- Having no neurological, orthopedic, communicational,
- Mental disability that affects the evaluations.
Key exclusion criteria (1 listed)
- Incomplete data and older adults not agreeing to participate in 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 |
|---|---|---|
| Muscle Quality IndexAlso: Lower Extremity Functional Scale, International Fall Efficiency ScaleEvaluations are applied to older adults to compare the results of muscle quality. | Other | – |
Primary outcome
Muscle Quality Index
Time frame: 6 months
Muscle Quality Index scored is calculated through anthropometric measurements of older adults. The muscle quality depends on the formula as follows: MQI (Watts) = ((Leg length×0.4)×Body mass×gravity ×10)/ Five Times Sit To Stand.
Lower Extremity Functional Scale
Time frame: 6 months
LEFS presents 20 questions about daily living activities. The questionnaire was developed to assess lower extremity functionality and can be used in older adults.The minimum and maximum total score ranges from 0 to 80. High scores show high functional status.
International Fall Efficiency Scale
Time frame: 6 months
The scale consist of items about fall concern during daily living activities. The minimum and maximum total score ranges from 16 to 64. High scores represents high fall concern.
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 7 Mar 2023.
- Results publication: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Results publication: PubMed 24508922Fragala MS, Fukuda DH, Stout JR, Townsend JR, Emerson NS, Boone CH, Beyer KS, Oliveira LP, Hoffman JR. Muscle quality index improves with resistance exercise training in older adults. Exp Gerontol. 2014 May;53:1-6. doi: 10.1016/j.exger.2014.01.027. Epub 2014 Feb 6.
- Results publication: PubMed 29329971Gadelha AB, Neri SGR, Nobrega OT, Pereira JC, Bottaro M, Fonseca A, Lima RM. Muscle quality is associated with dynamic balance, fear of falling, and falls in older women. Exp Gerontol. 2018 Apr;104:1-6. doi: 10.1016/j.exger.2018.01.003. Epub 2018 Jan 9. No abstract available.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data.
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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.
Güzin Kara Çakıcı, PhD principal investigator
Pamukkale University
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; Debility and Age-Related Sarcopenia, run by Pamukkale 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 1 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 7 Mar 2023. 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?
Muscle Quality Index (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT05758792, which also lists 3 linked publications.
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 7 Mar 2023.