Effects of the Cawthorne and Cooksey Exercise Program on Balance, Fear of Falling and Dizziness on Daily Life in Older Adults

Study Overview
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Brief Summary
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Background: The vestibular system is crucial for balance. Deficiencies in this system lead to instability and higher fall risks in older adults, a global health concern due to associated injuries. The Cawthorne and Cooksey program has proven effective in improving balance and reducing falls. This study investigates the program's impact on balance, fall fear, and dizziness in individuals over 65. Around 30 participants over 65 will be divided into intervention and control groups. The former will receive Cawthorne and Cooksey-based therapy, the latter, counseling on fall prevention and healthy living via leaflets. The 4-week intervention will occur thrice weekly, with two sessions via video. Pre-and-post assessments, along with a one-month follow-up, will be conducted.

Detailed Description
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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: Approximately 30 elderly individuals aged over 65 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.

Official Title
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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

Conditions
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Prevention, Older Adults, Accidental Falls, Exercise

Intervention / Treatment
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* Other: Cawthorne and Cooksey exercise program
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Individuals aged 65 - 80 Individuals with a Berg Balance Scale score less than 45 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cawthorne and Cooksey exercise program<br>The exercise program will span one month and will center on the Cawthorne and Cooksey exercises targeting the vestibular system. Each session will be conducted individually and last for twenty minutes. The program will take place three times a week, with the initial session held in person and the subsequent two via video assistance from their homes | Other: Cawthorne and Cooksey exercise program<br>* Participants in this group will receive an exercise program based on Cawthorne and Cooksey exercises. The intervention will last for 4 weeks, taking place three times a week, with the first session conducted in person and the remaining two assisted via video from their homes.<br>|
| Active Comparator: Control group<br>Information/Education on Fall Prevention and Promoting an Active, Healthy Lifestyle through Informational Leaflets. | Other: Control<br>* Control group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in balance will be assessed using the Berg Balance Scale (BBS) | The BBS, proposed by Berg (Berg et al., 1989; Berg et al., 1992), assesses balance in the elderly. It comprises 14 tests of increasing difficulty, requiring subjects to hold positions or perform specific tasks. Each test is graded from 0 to 4 points, reflecting the examinee's balancing ability (0 indicates low, while 4 indicates high ability). According to Berg et al. (1992), a score of 56 indicates functional balance, while a score below 45 signifies significant balance deficits associated with an increased fall risk. Studies demonstrate strong intra-rater and inter-rater reliability in elderly populations, with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992), and high content validity (Telenius et al., 2015). | pre-intervention, 4th week, 1-month follow-up | 
| Changes in the fear of falling will be assessed using the Short Falls Efficacy Scale International (Short FES-I) | The Short FES-I is a validated measure of concerns about falling, designed for use in both research and clinical settings. It is a condensed version of the Falls Efficacy Scale International (FES-I), consisting of seven questions and is particularly suitable for clinical practice. Scores on this scale range from 7 to 28, with higher scores indicating a greater fear of falling. In this study, we will employ the Greek version of the questionnaire, as validated by Billis et al. (2011). | pre-intervention, 4th week, 1-month follow-up | 
| Changes in the impact of dizziness on daily life will be assessed using The Dizziness Handicap Inventory questionnaire (DHI). | The DHI, questionnaire comprises 25 questions aimed at swiftly gauging the influence of dizziness. These questions are categorized into three sections representing functional, emotional, and physical aspects of dizziness and unsteadiness. Respondents can choose from three options: Always (worth 4 points), Sometimes (worth 2 points), or No (worth 0 points). Following completion, the scores for each question are totaled, resulting in a score ranging from 0 to 100 points. A score of 0 indicates that dizziness has no impact on daily life, while a score of 100 signifies a significant impact. The DHI has demonstrated strong psychometric properties, including high test-retest reliability (intrarater correlation coefficient [ICC] 0.72-0.97) and internal consistency reliability (α = 0.72-0.89) (Jacobson & Newman, 1990). | pre-intervention, 4th week, 1-month follow-up |