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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04347356
Other study ID # BVUsozyilmaz01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 19, 2020
Est. completion date May 15, 2020

Study information

Verified date June 2020
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 15, 2020
Est. primary completion date April 23, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years to 88 Years
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Primary 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. Baseline
Secondary 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). Baseline
Secondary 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. Baseline
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