NCT06291792

Brief Summary

The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging. 45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p\<0.05 level in the study.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

July 12, 2023

Last Update Submit

February 26, 2024

Conditions

Keywords

Fear of FallingBalanceOlder PersonsTelerehabilitationOtago Exercise

Outcome Measures

Primary Outcomes (7)

  • Numerical Pain Scale

    Numerical pain scale is used to classify pain from 1 to 10. 1 represents the lowest and 10 represents the highest pain value.

    within 10 minutes after intervention

  • Walking Speed

    Walking Speed

    within 10 minutes after intervention

  • lower extremity muscle strength

    lower extremity muscle strength measurement; It is used to determine the strength rate of lower extremity muscles. Muscles are classified from 0 to 5 according to the resistance applied against them and the counter force they show. While 0 indicates the lowest muscle strength, 5 indicates the highest muscle strength.

    within 10 minutes after intervention

  • Fall effectiveness scale

    There are 10 questions asked to the participant that are relevant to daily life at home. Each of the questions is answered numerically with a score between 1 and 10. The sum of the answers gives the total result of the test. If the result is higher than 70 points, the individual's fear of falling is high. As the fear of falling increases, the score of the test increases.

    within 10 minutes after intervention

  • Beck anxiety scale

    This scale asks about situations related to the person's body that are indicative of anxiety, such as sweating, shaking, fear, and discomfort in various areas. There are a total of 21 questions and 4 verbal answers that can be given to each question. Each verbal response has 4 different numerical scores between 0 and 3. At the end of the test, the numerical scores of the answers are added up. The total score gives the result of the test. If it is less than 21 points, the anxiety is low, between 22 and 35 points, the anxiety is moderate, and if it is 36 and above, it is said that there is severe anxiety.

    within 10 minutes after intervention

  • Tinetti balance and walking test

    It examines balance and walking status in 2 categories. There are 9 balance questions, followed by 7 questions about walking. There are 16 questions in total. A simple standard chair, a timer and a distance of about 15 meters is sufficient. Each question has 3 answers and each answer has numerical values of 0, 1, 2. The total score is calculated by adding the total score of the balance questions and the total score of the walking questions. The maximum score that balance questions can receive is 26, and the maximum score that walking questions can receive is 9. Total test score can be maximum 35. If the total test score is less than 18, it indicates a high risk of falling, if it is between 19-24, it indicates a slight risk, and if it is 24 and above, it indicates a low risk of falling.

    within 10 minutes after intervention

  • World Health Organization Quality of Life Scale:

    This scale, developed for scientific research and clinical studies on the elderly, consists of 24 questions. It aims to measure the quality of life of the elderly individual. Each question has 5 verbal answers and each verbal answer has a numerical value between 1 and 5. At the end of the test, the numerical values of all answers are summed. The total score gives the result of the test. As the score of the test increases, the quality of life of the elderly participant also increases.

    within 10 minutes after intervention

Study Arms (2)

Telerehabilitation Otago Exercise Group (TOEG)

EXPERIMENTAL

The use of Otago Exercise Program in the home environment using the telerehabilitation method. Telerehabilitation was performed with video and audio interviews 3 times a week for 45 minutes. The study will take 12 weeks. An 8-week treatment protocol will be applied. 4 weeks after the treatment protocol, the last measurement will be made and the study will be terminated.

Other: telerehabilitation otago exercise program

Face to face Otago Exercise Group (FOEG)

EXPERIMENTAL

Otago Exercise Program was applied in a face-to-face clinical setting. Interviews were held 3 times a week for 45 minutes. The study will take 12 weeks. An 8-week treatment protocol will be applied. 4 weeks after the treatment protocol, the last measurement will be made and the study will be terminated.

Other: face to face otago exercise program

Interventions

telerehabilitation otago exercise program

Telerehabilitation Otago Exercise Group (TOEG)

face to face otago exercise program

Face to face Otago Exercise Group (FOEG)

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Presence of the ability to walk without assistance
  • Living independently at home
  • Having a history of at least one fall in the last 12 months

You may not qualify if:

  • Having a score below 24 on the Mini Mental State Test
  • Using a walking aid
  • Having a history of uncontrolled epileptic seizures
  • Having a history of surgery within the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University research application center

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • SEFA HAKTAN HATIK, PhD

    Sinop University

    STUDY CHAIR

Central Study Contacts

Sefa Haktan HATIK, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

March 4, 2024

Study Start

November 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations