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

NCT06110325 | Completed

• 1 other identifier: EC-04/2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Older Adults; Accidental Falls; Prevention; Exercise

Keywords

Cawthorne and Cooksey Exercise; Balance; Likelihood of Fall; dizziness; physiotherapy

Outcome Measures

Primary Outcomes (3)

• 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 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).

  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

Study Arms (2)

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

Other: Cawthorne and Cooksey exercise program

Control group

ACTIVE COMPARATOR

Information/Education on Fall Prevention and Promoting an Active, Healthy Lifestyle through Informational Leaflets.

Other: Control

Interventions

Cawthorne and Cooksey exercise program OTHER

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.

Cawthorne and Cooksey exercise program

Control OTHER

Control group will receive counseling focused on fall prevention and promotion of an active, healthy lifestyle through informational leaflets.

Control group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit

Thessaloniki, Sindos Thessaloníki, Greece, 57400, Greece

Location

MeSH Terms

Conditions

Motor Activity; Dizziness

Condition Hierarchy (Ancestors)

Behavior; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitrios Lytras, PhD

  International Hellenic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor-blind randomized control trial. A masked assessor conducted the measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dimitrios Lytras PT, PhD, Principal Investigator, Senior Lecturer of Physiotherapy

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: October 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)