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Clinical Trials/NCT05002803
NCT05002803CompletedNot Applicable

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

University of Jordan1 site in 1 country20 target enrollmentStarted: August 4, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Incidence of Falls in the previous 12 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
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.

Arms & Interventions

Otago Exercise Program

Experimental

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

Intervention: Otago Exercise Program (Other)

Control group

No Intervention

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

Outcomes

Primary Outcomes

Incidence of Falls in the previous 12 months

Time Frame: Previous 12 months

Incidence of Falls and Falls Circumstances in the previous 12 months

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

  • The severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)(Immediately post intervention.)
  • Fear of Falling (using the Falls Efficacy Scale-International)(Immediately post intervention.)
  • Balance (using Chair balance test and Four test balance scale)(Immediately post intervention.)
  • Mobility (using Timed-Up and go)(Immediately post intervention.)
  • Grip strength (using a hand held dynamometer)(Immediately post intervention.)
  • The Quality of Life (using Medical Outcomes Study Short Form 12)(Immediately post intervention.)
  • Pain (using pain rating scale)(Immediately post intervention.)
  • The severity of fatigue (using the Modified Fatigue Impact Scale)(Immediately post intervention.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alia A. Alghwiri

Professor

University of Jordan

Study Sites (1)

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