Clinical trial NCT06110325: Effects of the Cawthorne and Cooksey Exercise Program on Balance, Fear of Falling and Dizziness on Daily Life in Older Adults
Official title: The Effectiveness of a Cawthorne and Cooksey Exercise Program on Balance, Fear of Falling and Dizziness on Daily Life in Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Accidental Falls
Prevention
Exercise
Keywords: Cawthorne and Cooksey Exercise
Balance
Likelihood of Fall
dizziness
physiotherapy
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A one-month assessor-blind randomized controlled trial will be conducted involving 30 seniors with balance deficits. Participants will be divided equally into two groups (intervention and control), each comprising 15 individuals. The intervention group will receive a Cawthorne and Cooksey-based exercise program, while the control group will receive counseling on fall prevention and guidance for maintaining an active and healthy lifestyle through informational leaflets.
Primary purpose: TREATMENT

Brief summary: Background: The vestibular system plays a crucial role in maintaining balance. Deficiencies in this system can result in instability and an increased risk of falls in older adults, posing a significant global health concern due to associated injuries. The Cawthorne and Cooksey program has demonstrated effectiveness in enhancing balance and reducing falls. This study aims to investigate the program's impact on balance, fear of falling, and dizziness in individuals aged 65 and older. Thirty-two older adults will be assigned to intervention and control groups. The intervention group will undergo a video-supported Cawthorne and Cooksey-based therapy, while the control group will receive counseling on fall prevention and healthy living through leaflets. The 4-week intervention will take place three times a week, including one face-to-face session and one via video. Pre- and post-assessments, along with a one-month follow-up, will be conducted.

Detailed description: Background: The vestibular system is a primary contributor to balance maintenance, serving as the absolute reference point in relation to other structures, including the visual system, labyrinth, and proprioceptive receptors. Any deficiency in these systems is automatically associated with balance disturbances, potentially leading to feelings of instability and an increased risk of falling. Falls among the elderly represent a global health concern due to their association with severe injuries and chronic disability. Annually, around 30% of community-dwelling seniors experience at least one fall, with 10%-20% falling two or more times. Any fall can result in injury, prolonged immobilization, decreased functional capacity, negative psychological impact, and in some cases, even mortality. The Cawthorne and Cooksey exercise program has demonstrated effectiveness in improving balance, reducing falls, and enhancing quality of life.

Aim: This study aims to investigate the effectiveness of Cawthorne and Cooksey exercises in enhancing balance, diminishing the fear of falls, and reducing dizziness in individuals over the age of 65.

Methods/Design: Thirty-two older adults are anticipated to participate in this study. Participants will be divided into two groups (intervention and control). The intervention group will receive therapy based on Cawthorne and Cooksey exercises, while the control group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets. The intervention will span 4 weeks, occurring three times a week, with the first session conducted in person and the remaining two via video assistance from their homes. Participants' balance, fear of falling, and dizziness will be assessed both before and after the intervention, and re-evaluated one-month post-intervention.

Expected results: This exercise program is expected to significantly benefit elderly individuals by improving their balance and reducing the fear of falling within this specific age group. Additionally, we hypothesize that these exercises will alleviate dizziness and enhance overall quality of life, as supported by existing literature.

Eligibility criteria: Inclusion Criteria

* Minimum age of 65 years
* Individuals with a Berg Balance Scale score less than 45
* Persistent dizziness for at least one month
* Individuals who have provided written consent for their participation

Exclusion Criteria:

* Individuals with dementia
* Individuals with cancer
* Individuals with multiple cardiovascular diseases
* Individuals unable to move independently even with the use of an aid.
* Individuals diagnosed with a neurodegenerative disease (e.g., Parkinson's disease)
* Individuals who have recently experienced a stroke
* Recent surgery
* Epilepsy
* History of psychiatric disorders

Primary outcomes:
measure: Changes in balance will be assessed using the Berg Balance Scale (BBS)
timeFrame: pre-intervention, 4th week, 1-month follow-up
measure: Changes in the fear of falling will be assessed using the Falls Efficacy Scale International (FES-I)
timeFrame: pre-intervention, 4th week, 1-month follow-up
measure: Changes in the impact of dizziness on daily life will be assessed using The Dizziness Handicap Inventory questionnaire (DHI).
timeFrame: pre-intervention, 4th week, 1-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
state: Sindos Thessaloníki, Greece
Study officials:
affiliation: International Hellenic University
name: Dimitrios Lytras, PhD
role: PRINCIPAL_INVESTIGATOR
References: