Clinical trial NCT05002803: The Development and Validation of the Arabic Otago Exercise Program
Official title: The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: Otago Exercise Program
Falls
Older adults
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Falls are common in older adults and may lead to disability or even death. Therefore, exercise programs that focus on preventing falls by improving strength and balance are important to investigate in older adults. One of the home-based exercise programs that was found effective in reducing the risk of falling and the rate of subsequent falls in older adults is the Otago exercise program (OEP). The OEP is an individualized home based retraining program that works mainly on balance and lower extremity strength through several progressive resistive exercises.

The OEP is available in English language since late 1990. However, its use in the Arabic-speaking countries is limited due to the language barrier. Therefore, translating such a program to the Arabic language would facilitate its use among Arabic-speaking older adults.

Therefore, this study aims:

* To translate the Otago Exercise Program (OEP) into the Arabic language.
* To assess the feasibility of the Arabic OEP in a pilot sample of Arabic-speaking older adults.

Detailed description: * Research ethics: This study got the ethics approval from the IRB at Jordan University Hospital at University of Jordan. A consent form that contains the study procedures will be prepared and signed from all participants. To insure the privacy of participants, every older adult will be assigned a study identification number. All results will be stored in a locked cabinet/computer only accessible by the researchers.
* Participants: Data will be collected prospectively from older adults in Jordan. Older adults will be approached to complete the program via Jordan University Hospital, community based organizations (e.g. Help-Age International Jordan) and social media platforms such as Facebook and WhatsApp.

Design:

Phase 1: Translation and cultural adaptation of the Otago Exercise Program (OEP) into the Arabic language.

* The permission of translating the program will be granted from its developers.
* English version of the program will be translated into the Arabic language in accordance with the World Health Organization (WHO) forward/backward translation protocol (https://www.who.int/substance_abuse/research_tools/translation/en/ ).
* An Arabic booklet of the OEP will be prepared.

Phase 2: Assessing feasibility of the OEP on a pilot sample of Arabic-speaking older adults using a focus group and a pilot Trial.

* The Arabic version of the OEP will be sent to an expert panel for review. Suggested changes will be considered and made.
* The Arabic version of the OEP will be sent to 2 groups that consist of 5 older adults each. They will be given sufficient time to go through the exercise manual before being invited to a focus group meeting to discuss the Arabic wording and feasibility of the Arabic version of the OEP.
* A topic guide will be prepared to assess the feasibility and user-friendliness of the Arabic OEP manual.
* The meeting will be recorded after taking their permission and the recording will be transcribed and analyzed.
* If there are major changes to the program, the experts will meet to make the appropriate changes and another focus group will be conducted.
* The final version of the Arabic OEP will be implemented for 8 weeks on a pilot sample of Arabic speaking older adults using a controlled design with 10 older adults in the treatment group and 10 older adults in the control group.

Eligibility criteria: Inclusion Criteria:

* Adults who are 60 years of age and older.
* Who can read and write in Arabic language.
* Who are able to walk outdoors with no more support than a single point cane.

Exclusion Criteria:

* Who have a serious orthopedic condition (e.g., recent lower limb surgery, severe arthritis of a lower limb) or major neurological disorder (e.g., stroke with unilateral or bilateral paresis, Parkinson disease or multiple sclerosis) that could restrict functional mobility.
* Who are unable to comprehend study information and consent processes due to any illness including dementia.

Primary outcomes:
measure: Incidence of Falls in the previous 12 months
timeFrame: Previous 12 months
measure: Incidence of falls during the treatment period (8 weeks)
timeFrame: Immediately post intervention.
Secondary outcomes:
measure: Fear of Falling (using the Falls Efficacy Scale-International)
timeFrame: Immediately post intervention.
measure: Balance (using Chair balance test and Four test balance scale)
timeFrame: Immediately post intervention.
measure: Mobility (using Timed-Up and go)
timeFrame: Immediately post intervention.
measure: Grip strength (using a hand held dynamometer)
timeFrame: Immediately post intervention.
measure: The Quality of Life (using Medical Outcomes Study Short Form 12)
timeFrame: Immediately post intervention.
measure: The severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)
timeFrame: Immediately post intervention.
measure: Pain (using pain rating scale)
timeFrame: Immediately post intervention.
measure: The severity of fatigue (using the Modified Fatigue Impact Scale)
timeFrame: Immediately post intervention.
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Alia A. Alghwiri, PhD
role: PRINCIPAL_INVESTIGATOR
References: