Older AdultsNCT06110325
Effects of the Cawthorne and Cooksey Exercise Program on Balance, Fear of Falling and Dizziness on Daily Life in Older Adults
A study testing Cawthorne and Cooksey exercise program in people with Older Adults and Accidental Falls, run by International Hellenic University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Older Adults, Accidental Falls, Prevention
- What is being tested?
- Cawthorne and Cooksey exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 15 Oct 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Recent surgery
- Epilepsy
- History of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
Thessaloniki, Sindos Thessaloníki, Greece, 57400
About this study
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
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.
Read the 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.
- Conditions
- Older Adults, Accidental Falls, Prevention, Exercise
- Being tested
- Cawthorne and Cooksey exercise program, Control
- Keywords
- Cawthorne and Cooksey Exercise, Balance, Likelihood of Fall, dizziness, physiotherapy
- Medical subject headings
- Motor Activity, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cawthorne and Cooksey exercise programOther
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.
ControlOther
Control group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets.
| Study group | Role | What they receive |
|---|---|---|
| Cawthorne and Cooksey exercise program | Experimental | 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 Receives: Other: Cawthorne and Cooksey exercise program |
| Control group | Active comparator | Information/Education on Fall Prevention and Promoting an Active, Healthy Lifestyle through Informational Leaflets. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: pre-intervention, 4th week, 1-month follow-up
Changes in the fear of falling will be assessed using the Falls Efficacy Scale International (FES-I)
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).
Measured: 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).
Measured: pre-intervention, 4th week, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start15 Oct 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
- Investigators
- Dimitrios Lytras, PhD, Principal investigator, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110325
- Sponsor's protocol ID
- EC-04/2023
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06110325
- Acronym / sponsor ID
- EC-04/2023
- Conditions
- Older Adults, Accidental Falls, Prevention, Exercise
- Keywords
- Cawthorne and Cooksey Exercise, Balance, Likelihood of Fall, dizziness, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cawthorne and Cooksey exercise program | Experimental | Other: Cawthorne and Cooksey exercise programThe 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 |
| Control group | Active comparator | Other: ControlInformation/Education on Fall Prevention and Promoting an Active, Healthy Lifestyle through Informational Leaflets. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cawthorne and Cooksey exercise programParticipants 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. | Other | Cawthorne and Cooksey exercise program |
| ControlControl group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets. | Other | Control group |
Primary outcome
Changes in balance will be assessed using the Berg Balance Scale (BBS)
Time frame: pre-intervention, 4th week, 1-month follow-up
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).
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
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).
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Lytras, PhD principal investigator
International Hellenic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cawthorne and Cooksey exercise program in people with Older Adults and Accidental Falls, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in balance will be assessed using the Berg Balance Scale (BBS) (time frame: pre-intervention, 4th week, 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.