NCT04347356

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

April 9, 2020

Last Update Submit

June 11, 2020

Conditions

Keywords

Balanceelderlyfear of movementfunctional capacitylower extremity muscle strengthquality of life

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Functional Capacity

    Baseline

  • Notthingham Health Profile Assesment

    Baseline

Eligibility Criteria

Age65 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects aged between 65-88 years who are a minimum score of 24 on the Mini-Mental State Examination, no cognitive impairment, and are independent of daily life activities will be included in the study.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Semiramis Ozyilmaz, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 15, 2020

Study Start

March 19, 2020

Primary Completion

April 23, 2020

Study Completion

May 15, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations