Clinical trial NCT05278312: Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Outcomes in Older Adults
Official title: Measuring the Effect of Using the Arabic Otago Exercise Program on Falls and Falls-related Outcomes in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adults
Keywords: Otago Exercise Program
Falls
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

● 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of falls
timeFrame: 2 months post intervention.
measure: Incidence of falls
timeFrame: 6 months post intervention.
measure: Incidence of falls
timeFrame: 12 months post intervention.
Secondary outcomes:
measure: Fear of Falling (using the Falls Efficacy Scale-International)
timeFrame: 2 months post intervention.
measure: Balance (using Chair balance test and Four test balance scale)
timeFrame: 2 months post intervention.
measure: Mobility (using Timed-Up and go)
timeFrame: 2 months post intervention.
measure: Muscle strength (Hand grip and Quadriceps muscle strength using a dynamometer)
timeFrame: 2 months post intervention.
measure: The Quality of sleep (Using Pittsburgh Sleep Quality Index)
timeFrame: 2 months post intervention.
measure: the severity of Anxiety and Depression (using Hospital Anxiety and Depression Scale)
timeFrame: 2 months post intervention.
measure: The Quality of Life (using Medical Outcomes Study Short Form 12)
timeFrame: 2 months post intervention.
measure: Cognitive ability (using Montreal Cognitive Assessment)
timeFrame: 2 months post intervention.
measure: Sarcopenia (using the bio-impedance analysis)
timeFrame: 2 months post intervention.
measure: Pain (using pain rating scale)
timeFrame: 2 months post intervention.
measure: Activities of daily living (using Katz index of daily living)
timeFrame: 2 months post intervention.
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Alia Alghwiri
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Alia A. Alghwiri, PhD
role: PRINCIPAL_INVESTIGATOR
References: