ClinicalTrials.gg
CompletedNCT05002803Updated Apr 7, 2023

The Development and Validation of the Arabic Otago Exercise Program

An interventional study of Otago Exercise Program in Older Adults, sponsored by University of Jordan. Completed at 1 site in Jordan. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by University of Jordan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Older Adults

Keywords

  • Otago Exercise Program
  • Falls
  • Older adults
03

In context

Lead sponsor

University of Jordan is the lead sponsor of 130 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Otago Exercise Program

    Older adults will receive the Arabic Otago Exercise Program for 8 weeks plus health awareness videos.

    Other: Otago Exercise Program

  • No intervention
    Control group

    Older adults will receive only health awareness videos every 2 weeks.

Interventions

  • OtherOtago Exercise Program

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

06

What researchers measure

Primary outcomes

  1. Incidence of Falls in the previous 12 months

    Incidence of Falls and Falls Circumstances in the previous 12 months

    Time frame: Previous 12 months

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

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

    Time frame: Immediately post intervention.

Secondary outcomes

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

    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).

    Time frame: Immediately post intervention.

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

    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.

    Time frame: Immediately post intervention.

  3. Mobility (using Timed-Up and go)

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

    Time frame: Immediately post intervention.

  4. Grip strength (using a hand held dynamometer)

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

    Time frame: Immediately post intervention.

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

    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).

    Time frame: Immediately post intervention.

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

    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).

    Time frame: Immediately post intervention.

  7. Pain (using pain rating scale)

    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).

    Time frame: Immediately post intervention.

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

    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).

    Time frame: Immediately post intervention.

07

Study locations

1 site
  • University of Jordan
    Amman, 11942, Jordan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2021 to primary completion in Dec 2022, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2021
First posted
Aug 12, 2021
StartActual
Aug 4, 2021
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Apr 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002803
Responsible party
Alia A. Alghwiri (Professor, University of Jordan) — Principal investigator
First posted
Aug 12, 2021
Start date
Aug 4, 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Apr 7, 2023

Study contacts

Alia A. Alghwiri, PhD
principal investigator · University of Jordan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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