NCT05002803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

August 4, 2021

Last Update Submit

April 5, 2023

Conditions

Keywords

Otago Exercise ProgramFallsOlder adults

Outcome Measures

Primary Outcomes (2)

  • Incidence of Falls in the previous 12 months

    Incidence of Falls and Falls Circumstances in the previous 12 months

    Previous 12 months

  • 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.

    Immediately post intervention.

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

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

Other: Otago Exercise Program

Control group

NO INTERVENTION

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

Interventions

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

Otago Exercise Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

Location

Study Officials

  • Alia A. Alghwiri, PhD

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 12, 2021

Study Start

August 4, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations