ElderlyNCT04347356
Relationship of Balance, Functional Capacity and Fear of Movement With Lower Extremity Muscle Strength in Elderly
An observational study of Elderly, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Aging is a period in which the morphological, physiological and pathological changes progress negatively, accompanied by various diseases and regression of physical and mental abilities. In this period, the individual experiences biological and physiological losses as well as social problems in his/her life. Read more about this study
- Who is it for?
- Ages 65 to 88 years
- Conditions the study is for
- Elderly
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Mar 2020to 15 May 2020
- 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 88 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Subjects aged between 65-88 years who are a minimum score of 24 on the Mini-Mental State Examination, no cognitive impairment, and are independent of daily life activities will be included in the study.
Who may be able to join
- The participant must be 65-88 years old,
- The participant must have a minimus score of 24 on the Mini-Mental State Examination (MMSE),
- No cognitive impairment,
- The participant must be independent of daily life activities (must not use an assistive device for walking).
Who cannot join
- Having a disease that can affect balance (vestibular, neurological, orthopedic ...) performing regular exercise
- Uncontrolled hypertension or arrhythmia
- Uncontrolled diabetes mellitus
- Orthopedic, neurological or musculoskeletal problems
- Postural hypotension
- Obesity (body mass index>40)
- Uncompensated clinical conditions such as chronic obstructive pulmonary disease, interstitial lung disease, heart failure, or rheumatic and psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Balance, Functional Capacity, Fear of Movement and Quality of Life With Lower Extremity Muscle Strength in Elderly People
Aging is a period in which the morphological, physiological and pathological changes progress negatively, accompanied by various diseases and regression of physical and mental abilities. In this period, the individual experiences biological and physiological losses as well as social problems in his/her life. From the age of 65, approximately 80% decrease in muscle strength can be observed and this decrease is especially noticeable in the leg and trunk muscles. Decreases in the strength of the muscles in the lower extremities may cause deterioration in physical function, decrease in mobility, increase in falling related accidents, also can cause osteoporosis and physical deficiencies. Determining the structures with which the lower extremity muscle strength is related will facilitate the precautionary measures for the inadequacies that will arise in the later stages of aging.
This study was performed to analyze the relationship of lower extremity muscle strength with balance, functional capacity, fear of movement and quality of life in elderly individuals living in nursing homes.
- Conditions
- Elderly
- Keywords
- Balance, elderly, fear of movement, functional capacity, lower extremity muscle strength, quality of life
- Medical subject headings
- Kinesiophobia
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Muscle Strength
Lower limb muscle strength will be assessed by sit-to-stand test. Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.
Measured: Baseline
Static Balance
Static balance will be assessed by single leg stance test. The time that patients can remain in balance on the dominant leg with their eyes open is recorded. Time under 10 seconds indicates loss balance.
Measured: Baseline
Dynamic Balance
Dynamic balance will be assessed by the Timed Up and Go Test. The TUG measures the time it takes for a participant to stand up from a standard chair, walk 3m, turn, walk back to the chair, and sit down again. The cut-off score of 12 seconds in older persons is the threshold value for an increased risk of falling.
Measured: Baseline
Postural Balance
The postural balance will be assessed by the Berg Balance Scale. It assesses 14 functions related to daily activities. A score of 0 represents an inability and a score of 4 represents independently. The maximum score is 56. A score of less than 45 indicates balance loss.
Measured: Baseline
Fear of Movement
Fear of movement will be assessed by the Tampa Scale for Kinesiophobia. Individuals get a minimum of 17 and a maximum of 68 points. A high score indicates an increasing degree of kinesiophobia.
Measured: Baseline
Secondary outcomes (2)
Functional Capacity
Functional capacity will measured with the 6-minute walk test.Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).
Measured: Baseline
Notthingham Health Profile Assesment
The quality of life will be assessed by Notthingham Health Profile. The minimum score is '0', the maximum score is '100'. "0 score" shows the best health, "100 score" shows the worst health.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start19 Mar 2020
- Primary completion23 Apr 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Semiramis Ozyilmaz, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347356
- Sponsor's protocol ID
- BVUsozyilmaz01
- Status last verified
- Jun 2020
- First submitted
- 9 Apr 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Balance, Functional Capacity, Fear of Movement and Quality of Life With Lower Extremity Muscle Strength in Elderly People
- ClinicalTrials.gov ID
- NCT04347356
- Acronym / sponsor ID
- BVUsozyilmaz01
- Conditions
- Elderly
- Keywords
- Balance, elderly, fear of movement, functional capacity, lower extremity muscle strength, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 15 Apr 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 is a period in which the morphological, physiological and pathological changes progress negatively, accompanied by various diseases and regression of physical and mental abilities. In this period, the individual experiences biological and physiological losses as well as social problems in his/her life. From the age of 65, approximately 80% decrease in muscle strength can be observed and this decrease is especially noticeable in the leg and trunk muscles. Decreases in the strength of the muscles in the lower extremities may cause deterioration in physical function, decrease in mobility, increase in falling related accidents, also can cause osteoporosis and physical deficiencies. Determining the structures with which the lower extremity muscle strength is related will facilitate the precautionary measures for the inadequacies that will arise in the later stages of aging.
This study was performed to analyze the relationship of lower extremity muscle strength with balance, functional capacity, fear of movement and quality of life in elderly individuals living in nursing homes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Subjects aged between 65-88 years who are a minimum score of 24 on the Mini-Mental State Examination, no cognitive impairment, and are independent of daily life activities will be included in the study.
Key inclusion criteria (4 listed)
- The participant must be 65-88 years old,
- The participant must have a minimus score of 24 on the Mini-Mental State Examination (MMSE),
- No cognitive impairment,
- The participant must be independent of daily life activities (must not use an assistive device for walking).
Key exclusion criteria (7 listed)
- Having a disease that can affect balance (vestibular, neurological, orthopedic ...) performing regular exercise
- Uncontrolled hypertension or arrhythmia
- Uncontrolled diabetes mellitus
- Orthopedic, neurological or musculoskeletal problems
- Postural hypotension
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
Lower Extremity Muscle Strength
Time frame: Baseline
Lower limb muscle strength will be assessed by sit-to-stand test. Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.
Static Balance
Time frame: Baseline
Static balance will be assessed by single leg stance test. The time that patients can remain in balance on the dominant leg with their eyes open is recorded. Time under 10 seconds indicates loss balance.
Dynamic Balance
Time frame: Baseline
Dynamic balance will be assessed by the Timed Up and Go Test. The TUG measures the time it takes for a participant to stand up from a standard chair, walk 3m, turn, walk back to the chair, and sit down again. The cut-off score of 12 seconds in older persons is the threshold value for an increased risk of falling.
Postural Balance
Time frame: Baseline
The postural balance will be assessed by the Berg Balance Scale. It assesses 14 functions related to daily activities. A score of 0 represents an inability and a score of 4 represents independently. The maximum score is 56. A score of less than 45 indicates balance loss.
Fear of Movement
Time frame: Baseline
Fear of movement will be assessed by the Tampa Scale for Kinesiophobia. Individuals get a minimum of 17 and a maximum of 68 points. A high score indicates an increasing degree of kinesiophobia.
2 secondary outcomes
Functional Capacity
Time frame: Baseline
Notthingham Health Profile Assesment
Time frame: Baseline
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 11 Jun 2020.
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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.
Semiramis Ozyilmaz, PhD principal investigator
Bezmialem Vakif 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 Elderly, run by Bezmialem Vakif 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 7 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 11 Jun 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?
Lower Extremity Muscle Strength (time frame: Baseline). The study lists 5 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 11 Jun 2020.