Clinical trial NCT06267833: The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program
Official title: The Effect of Adding Trunk and Upper Extremity Exercises to the Otago Exercise Program on Balance Performance, Fall Risk, and Fear of Falling in Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Geriatrics
Balance
Exercise
Fall Prevention
Keywords: Geriatrics
Balance
Fall prevention
Mobil game
telerehabilitation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants.


Eligibility criteria: Inclusion Criteria:

* To be aged 65 years and older.
* To have the ability to speak, read, comprehend, and write in Turkish.
* To have a body mass index \<35 kg/m2 (not being severely or morbidly obese).
* To have experienced one or more falls within the past 1 year.
* To possess cognitive abilities enabling the understanding and implementation of the educational sessions to be conducted in the study (having scored ≥ 24 points on the Mini-Mental State Examination).
* To be able to perform daily activities independently (scoring 5-6 points on the Katz Activities of Daily Living Scale).
* To demonstrate a reach performance of ≥ 16 centimeters in the Functional Reach Test.
* To be able to walk independently (regardless of the use of walking aids).
* To have internet connectivity at home.
* To permit the implementation of exercise protocols under the supervision of the researcher in the home environment.
* To allow for periodic home visits by the researcher for the implementation of exercise protocols.
* To agree to have a physically suitable area in the home for exercise protocols or to make necessary arrangements to render the home environment suitable for exercise.

Exclusion Criteria:

* To have absolute contraindications for strength and aerobic exercises.
* To have chronic pain in the lower body and extremities.
* To have a disorder related to the vestibular system.
* To engage in regular exercise that may affect performance outcomes.
* To decline participation in the study.

Primary outcomes:
measure: Mini BESTest
timeFrame: 15 minutes
Secondary outcomes:
measure: Functional Reach Test
timeFrame: 3 minutes
measure: International Falls Efficacy Scale
timeFrame: 10 minutes
Other outcomes:
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Study officials:
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