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Completed

NCT Number: NCT05002803

The Development and Validation of the Arabic Otago Exercise Program

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.

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Key information

Conditions

Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jordan

Amman, 11942, Jordan

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Otago Exercise Program

Other

A Home-based Exercise Program to improve strength and balance and prevent falls.

Primary outcomes

  1. Incidence of Falls in the previous 12 months

    Time frame: Previous 12 months

    Incidence of Falls and Falls Circumstances in the previous 12 months

  2. Incidence of falls during the treatment period (8 weeks)

    Time frame: Immediately post intervention.

    Incidence of falls during the treatment period (previous 2 months) to assess the effect of the intervention on the incidence of falls.

Secondary outcomes

  1. Fear of Falling (using the Falls Efficacy Scale-International)

    Time frame: Immediately post intervention.

    The effect of the intervention on fear of falling. The total score ranges between 16 and 64 with a higher score indicates greater fear of falling (worse).

  2. Balance (using Chair balance test and Four test balance scale)

    Time frame: Immediately post intervention.

    The effect of the intervention on balance. The time taken to conduct these balance tasks are timed using a stopwatch. The longer the time taken by the participant to perform the tasks, the worse the balance. There is no minimum or maximum scores for these tests.

  3. Mobility (using Timed-Up and go)

    Time frame: Immediately post intervention.

    The effect of the intervention on mobility. This assessments of mobility is timed out using a stopwatch.

  4. Grip strength (using a hand held dynamometer)

    Time frame: Immediately post intervention.

    The effect of the intervention on grip strength. The strength of Hand grip muscle will be assessed using a dynamometer in kilograms.

  5. The Quality of Life (using Medical Outcomes Study Short Form 12)

    Time frame: Immediately post intervention.

    The effect of the intervention on Quality of Life. The total score ranges between 0% to 100% with higher score indicates a better quality of life (better).

  6. The severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)

    Time frame: Immediately post intervention.

    The effect of the intervention on the severity of Anxiety and Depression. The total score for each subscale of the HADS ranges from 0 to 21 with higher score indicates more severe anxiety or depression (worse).

  7. Pain (using pain rating scale)

    Time frame: Immediately post intervention.

    The effect of the intervention on pain. The total score of PRS ranges between 0 to 10 with higher score indicates more pain and interference with discomfort (worse).

  8. The severity of fatigue (using the Modified Fatigue Impact Scale)

    Time frame: Immediately post intervention.

    The effect of the intervention on fatigue. The total score of MFIS ranges between 0 to 84 with higher score indicates higher impact of fatigue on on daily functioning (worse).

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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