The Development and Validation of the Arabic Otago Exercise Program

Sponsor
University of Jordan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05002803
Collaborator
(none)
20
1
2
9.9
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Otago Exercise Program
N/A

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 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Development and Validation of the Arabic Otago Exercise Program: A Feasibility Pilot Study
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Otago Exercise Program

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

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

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Falls in the previous 12 months [Previous 12 months]

    Incidence of Falls and Falls Circumstances in the previous 12 months

  2. Incidence of falls during the treatment period [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 Outcome Measures

  1. Fear of Falling (using the Falls Efficacy Scale-International) [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) [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) [Post intervention.]

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

  4. Muscle strength (Hand grip and Quadriceps muscle strength using a dynamometer) [Post intervention.]

    The effect of the intervention on upper and lower extremity muscle strength. The strength of Hand grip and Quadriceps muscle will be assessed using a dynamometer in kilograms.

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Jordan Amman Jordan 11942

Sponsors and Collaborators

  • University of Jordan

Investigators

  • Principal Investigator: Alia A. Alghwiri, PhD, University of Jordan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alia A. Alghwiri, Professor, University of Jordan
ClinicalTrials.gov Identifier:
NCT05002803
Other Study ID Numbers:
  • 2021/134
First Posted:
Aug 12, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alia A. Alghwiri, Professor, University of Jordan

Study Results

No Results Posted as of May 18, 2022