- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110325
Effects of the Cawthorne and Cooksey Exercise Program on Balance, Fear of Falling and Dizziness on Daily Life in Older Adults
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindos Thessaloníki, Greece
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Thessaloníki, Sindos Thessaloníki, Greece, Greece, 57400
- Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cawthorne and Cooksey exercise program
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
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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.
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Active Comparator: Control group
Information/Education on Fall Prevention and Promoting an Active, Healthy Lifestyle through Informational Leaflets.
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Control group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in balance will be assessed using the Berg Balance Scale (BBS)
Time Frame: pre-intervention, 4th week, 1-month follow-up
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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).
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pre-intervention, 4th week, 1-month follow-up
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Changes in the impact of dizziness on daily life will be assessed using The Dizziness Handicap Inventory questionnaire (DHI).
Time Frame: pre-intervention, 4th week, 1-month follow-up
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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).
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pre-intervention, 4th week, 1-month follow-up
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Changes in the fear of falling will be assessed using the Falls Efficacy Scale International (FES-I)
Time Frame: pre-intervention, 4th week, 1-month follow-up
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The FES-I is a validated measure of concerns about falling, designed for use in both research and clinical settings.
This questionnaire comprises 16 items and is particularly suitable for research as well as for clinical practice.
Scores on the scale range from a minimum of 16 (indicating minimal concern about falling) to a maximum of 64 (indicating pronounced apprehension about falling), with higher scores indicating an elevated fear of falling.
In this study, we will utilize the Greek version of the questionnaire, as validated by Billis et al. (2011).
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pre-intervention, 4th week, 1-month follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Dimitrios Lytras, PhD, International Hellenic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC-04/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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