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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04247789
Other study ID # OrduU7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 23, 2019
Est. completion date February 5, 2020

Study information

Verified date February 2020
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date February 5, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Self-reported questionairres
the fatigue will be determined through self reported questionnairres

Locations

Country Name City State
Turkey Sevim ACARÖZ CANDAN Ordu Altinordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes
Secondary 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. 5 minutes
Secondary 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. 6-10 minutes
Secondary 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. 5 minutes
Secondary 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. 2 minutes
Secondary 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). 1 minutes
Secondary Body mass The weight will be measured in kilograms without shoes and within thin clothes 30 seconds.
Secondary Body Height The height will be determined in an erect standing position as centimeters. 30 seconds
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