FatigueNCT04247789
The Associated Factors With Fatigue in Older Adults Living in a Rest Home
An observational study of Fatigue and Older People--Abuse of, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
Fatigue is an important and prevalent problem in older adults. The ratio of fatigue may rise in older adults who live in nursing homes/rest homes. In the literature, a few studies investigated the prevalence of fatigue, and there is no study explaining the associated factors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fatigue, Older People--Abuse of
- What is being tested?
- Self-reported questionairres
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2019to 5 Feb 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The older adults living in a rest home
Who may be able to join
- age older than 65 years
- able to walk with/without walking device
- living at a rest home for at least 12 months
- being voluntary for all assessments
Who cannot join
- had a cognitive problem (MMSE<24 scores)
- had a neurologic disorder
- had a cancer history
- had uncontrolled cardiopulmonary dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Fatigue in Older Adults Living in a Rest Home: Prevalence and Associated Factors
Fatigue is an important and prevalent problem in older adults. The ratio of fatigue may rise in older adults who live in nursing homes/rest homes. In the literature, a few studies investigated the prevalence of fatigue, and there is no study explaining the associated factors. The aim of the present study is to investigate the prevalence of fatigue in rest home residents and to determine the associated variables with fatigue.
- Conditions
- Fatigue, Older People--Abuse of
- Being tested
- Self-reported questionairres
- Keywords
- fatigue, physical function, strength, older adults, nursing homes
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-reported questionairresOther
the fatigue will be determined through self reported questionnairres
| Study group | Role | What they receive |
|---|---|---|
| Total sample | This group consists of older adults living in a rest home, who are proper for inclusion criteria Receives: Other: Self-reported questionairres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Severity Scale (FSS)
The FSS is the most frequently used scale among the unidimensional scales which have been developed to assess fatigue. The scale rates the fatigue with nine items, For each item, the patient is asked to grade the fatigue level between 1 and 7, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 28 or higher generally indicates presence of fatigue.
Measured: 5 minutes
Secondary outcomes (7)
Strength assessment
Quadriceps strength and handgrip strength will be measured by digital dynamometers named as Lafayette and Jamar dynamometers, respectively. Quadriceps strength will be measured in a sitting position with hip and knee flexed 90 degrees. The participants extend the knee and the examiner applies an opposite force to break this position. This test will be performed three times and the maximum value will be recorded in a kilogram. The handgrip strength will be assessed according to the American Society of Hand Therapists. The participants will be asked to squeeze as forcefull as possible the dynamometer. The maximum score of three trials will be recorded in kliograms.
Measured: 5 minutes
Functional Capacity
Six-minutes walk test will be used to evaluate the functional capacity or cardiorespiratory fitness. The participants will be walking in a 30-meter corridor for 6-minutes. If necessary the participants can use the walking assistive devices and take a rest. The total distance will be recorded in meters.
Measured: 6-10 minutes
Physical Function
Short Physical Performance Battery will be used to measure physical functioning. This battery includes 3 subdomains (gait speed, balance and chair stand test). The totatl score changes between 0 and 12. The higher score indicates better performance.
Measured: 5 minutes
Boddy mass index
The body measures (weight and height) will be assessed in kilograms and meters. The index will be calculated by dividing body weight by height squared.
Measured: 2 minutes
Physical activity habits
Physical activity habits will be determined with a question" How many times did you exercise for 30 minutes or more with a certain tempo?" This question will be recorded as a dichotomous variable, 1 indicates present physical activity habits (>2 times) and 0 no physical activity habits (<3 times).
Measured: 1 minutes
Body mass
The weight will be measured in kilograms without shoes and within thin clothes
Measured: 30 seconds.
Body Height
The height will be determined in an erect standing position as centimeters.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start23 Dec 2019
- Primary completion31 Jan 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247789
- Sponsor's protocol ID
- OrduU7
- Status last verified
- Feb 2020
- First submitted
- 28 Jan 2020
- Last updated
- 21 Feb 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 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fatigue in Older Adults Living in a Rest Home: Prevalence and Associated Factors
- ClinicalTrials.gov ID
- NCT04247789
- Acronym / sponsor ID
- OrduU7
- Conditions
- Fatigue, Older People--Abuse of
- Keywords
- fatigue, physical function, strength, older adults, nursing homes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 30 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.
Fatigue is an important and prevalent problem in older adults. The ratio of fatigue may rise in older adults who live in nursing homes/rest homes. In the literature, a few studies investigated the prevalence of fatigue, and there is no study explaining the associated factors. The aim of the present study is to investigate the prevalence of fatigue in rest home residents and to determine the associated variables with fatigue.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total sample | – | Other: Self-reported questionairresThis group consists of older adults living in a rest home, who are proper for inclusion criteria |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The older adults living in a rest home
Key inclusion criteria (4 listed)
- age older than 65 years
- able to walk with/without walking device
- living at a rest home for at least 12 months
- being voluntary for all assessments
Key exclusion criteria (4 listed)
- had a cognitive problem (MMSE<24 scores)
- had a neurologic disorder
- had a cancer history
- had uncontrolled cardiopulmonary dysfunction
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 |
|---|---|---|
| Self-reported questionairresthe fatigue will be determined through self reported questionnairres | Other | Total sample |
Primary outcome
Fall Severity Scale (FSS)
Time frame: 5 minutes
The FSS is the most frequently used scale among the unidimensional scales which have been developed to assess fatigue. The scale rates the fatigue with nine items, For each item, the patient is asked to grade the fatigue level between 1 and 7, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 28 or higher generally indicates presence of fatigue.
7 secondary outcomes
Strength assessment
Time frame: 5 minutes
Functional Capacity
Time frame: 6-10 minutes
Physical Function
Time frame: 5 minutes
Boddy mass index
Time frame: 2 minutes
Physical activity habits
Time frame: 1 minutes
Body mass
Time frame: 30 seconds.
Body Height
Time frame: 30 seconds
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 21 Feb 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?
An observational study of Fatigue and Older People--Abuse of, run by Ordu 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 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 21 Feb 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?
Fall Severity Scale (FSS) (time frame: 5 minutes). 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 21 Feb 2020.