Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Outcomes in Older Adults

NCT ID: NCT05278312

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Therefore, this study aims to assess the effectiveness of this program on falls prevention and falls-related outcomes using a Randomized Controlled Trial in a sample of Jordanian older adults.

Detailed Description

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❖ 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:

● This will be a single blinded randomized controlled trial study with 2 groups: treatment group who will receive the OEP plus health awareness videos every 2 weeks and a control group who will receive the same health awareness videos only every 2 weeks.

1. Eligible older adults will be recruited for the RCT.
2. Baseline assessment will be conducted by a blind assessor.
3. Participant will be randomized using a computer-based randomization tool into either the treatment (OEP) or the control group (awareness videos). The treatment group will receive the OEP for 8 weeks plus health awareness videos. The control group will receive the same health awareness videos every 2 weeks for 8 weeks. The treatment group will be trained by a researcher different from the one conducting the assessments.

The following topics will be covered in the health awareness videos:

* Be physically active.
* Maintain healthy bones, joints and muscles.
* Combat depression.
* Sleep.

Conditions

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Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Otago Exercise Program

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

Group Type EXPERIMENTAL

Otago Exercise Program

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Otago Exercise Program

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Alia A. Alghwiri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alia A. Alghwiri, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jordan

Locations

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Alia Alghwiri

Amman, , Jordan

Site Status RECRUITING

University of Jordan

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Alia A. Alghwiri, PhD

Role: CONTACT

0798525162

Jennifer A Muhaidat, PhD

Role: CONTACT

Facility Contacts

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Alia Alghwiri, PhD

Role: primary

Alia A. Alghwiri

Role: primary

0798525162

Other Identifiers

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10/2021/9426

Identifier Type: -

Identifier Source: org_study_id

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