NCT05278312

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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

March 3, 2022

Last Update Submit

July 7, 2023

Conditions

Older Adults

Keywords

Otago Exercise ProgramFalls

Outcome Measures

Primary Outcomes (3)

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    2 months post intervention.

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    6 months post intervention.

  • Incidence of falls

    The effect of the intervention on the incidence of falls.

    12 months post intervention.

Secondary Outcomes (11)

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

    2 months post intervention.

  • Balance (using Chair balance test and Four test balance scale)

    2 months post intervention.

  • Mobility (using Timed-Up and go)

    2 months post intervention.

  • Muscle strength (Hand grip and Quadriceps muscle strength using a dynamometer)

    2 months post intervention.

  • The Quality of sleep (Using Pittsburgh Sleep Quality Index)

    2 months post intervention.

  • +6 more secondary outcomes

Study Arms (2)

Otago Exercise Program

EXPERIMENTAL

Older adults will receive the 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

Otago Exercise ProgramOTHER

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 (2)

Alia Alghwiri

Amman, 11942, Jordan

RECRUITING

University of Jordan

Amman, 11942, Jordan

RECRUITING

Study Officials

  • Alia A. Alghwiri, PhD

    University of Jordan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alia A. Alghwiri, PhD

CONTACT

0798525162ALIA.ALGHWIRI@GMAIL.COM

Jennifer A Muhaidat, PhD

CONTACT

j.muhaidat@ju.edu.jo

Study Design

Study Type
interventional
Phase
not applicable
Allocation
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

March 3, 2022

First Posted

March 14, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

JO(2)