- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04247789
The Associated Factors With Fatigue in Older Adults Living in a Rest Home
February 19, 2020 updated by: Sevim ACARÖZ CANDAN, T.C. ORDU ÜNİVERSİTESİ
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Altinordu
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Ordu, Altinordu, Turkey, 52100
- Sevim ACARÖZ CANDAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The older adults living in a rest home
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- had a cognitive problem (MMSE<24 scores)
- had a neurologic disorder
- had a cancer history
- had uncontrolled cardiopulmonary dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Total sample
This group consists of older adults living in a rest home, who are proper for inclusion criteria
|
the fatigue will be determined through self reported questionnairres
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength assessment
Time Frame: 5 minutes
|
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.
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5 minutes
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Functional Capacity
Time Frame: 6-10 minutes
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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.
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6-10 minutes
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Physical Function
Time Frame: 5 minutes
|
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.
|
5 minutes
|
Boddy mass index
Time Frame: 2 minutes
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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.
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2 minutes
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Physical activity habits
Time Frame: 1 minutes
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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).
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1 minutes
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Body mass
Time Frame: 30 seconds.
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The weight will be measured in kilograms without shoes and within thin clothes
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30 seconds.
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Body Height
Time Frame: 30 seconds
|
The height will be determined in an erect standing position as centimeters.
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30 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 23, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
February 5, 2020
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 30, 2020
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrduU7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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