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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • Altinordu
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Total sample
This group consists of older adults living in a rest home, who are proper for inclusion criteria
Other: Self-reported questionairres
the fatigue will be determined through self reported questionnairres

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
5 minutes
Functional Capacity
Time Frame: 6-10 minutes
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.
6-10 minutes
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
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.
2 minutes
Physical activity habits
Time Frame: 1 minutes
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).
1 minutes
Body mass
Time Frame: 30 seconds.
The weight will be measured in kilograms without shoes and within thin clothes
30 seconds.
Body Height
Time Frame: 30 seconds
The height will be determined in an erect standing position as centimeters.
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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