- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06577740
Group-based and Dual-task Focused Otago Exercises in Geriatric Individuals With Kinesiophobia
August 27, 2024 updated by: ebrar atak, Istanbul Medipol University Hospital
Investigation of the Effects of Group-Based and Dual-Task Focused Otago Exercises on Kinesiophobia, Musculoskeletal System and Psychosocial Status in Geriatric Individuals With Kinesiophobia
The aim of our study was to investigate the effects of group-based and dual-task focused otago exercises on kinesiophobia, musculoskeletal system and psychosocial status in geriatric individuals with kinesiophobia.
In the study : 1. Do group-based and dual-task focused otago exercises have an effect on kinesiophobia in geriatric individuals with kinesiophobia? 2. Do group-based and dual-task focused otago exercises have an effect on the musculoskeletal system in geriatric individuals with kinesiophobia? 3. Do group-based and dual-task focused otago exercises have an effect on the psychosocial status of geriatric individuals with kinesiophobia? 4. Do group-based and dual-task focused otago exercises have an effect on cognitive function in geriatric individuals with kinesiophobia?
The questions were answered.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our study was conducted as a cross-controlled study on 20 geriatric individuals.
The study lasted 12 weeks.
The participants in the study were given group otago exercises for 4 weeks, face to face once a week for 30 minutes, and remotely monitored twice a week with handouts containing the exercises.
They were asked to walk normally for 30 minutes on 2 days a week.
Then, they entered a 4-week washout period.
After the washout period, the participants in the study were given group otago exercises for 4 weeks, face to face for 30 minutes, and remotely monitored twice a week with handouts containing the exercises.
They were asked to walk normally for 30 minutes on 2 days a week.
Before starting the study, participants were given a demographic information form, Tampa Kinesiophobia Scale for kinesiophobia, Berg Balance Scale for balance assessment, Short Form Geriatric Depression Scale for psychosocial status, 5-times sit-to-stand test to assess fall risk and lower extremity muscle strength, Timed Up and Go test to assess mobility, and Mini Mental State Test and Montreal Cognitive Assessment Test to assess cognitive function.
These tests were repeated at the end of the first 4 sessions and the last 4 sessions, and pre- and post-test values were measured.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Amine Ataç
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Individuals aged 65 and over
- Participants who can read and write in Turkish
- Participants who scored 38 or higher on the Tampa Kinesiophobia Scale
- Participants who received 24 points or more from the Mini Mental State Test
- Participating in the study voluntarily
- Individuals who do not have any disability such as vision, hearing, limb loss, etc.
- Participants who can walk independently
Exclusion Criteria:
- Medication status that increases the risk of falls (determined based on information from nursing home nurses and physiotherapists).
- Individuals who are bedridden or wheelchair bound
- Individuals with diagnosed mental or psychological problems (The individual's inability to perceive the scales to be applied)
- Individuals with diagnosed serious neurological or orthopedic problems
- Individuals with diagnosed serious pulmonary or cardiac disease
- Individuals with uncontrolled hypertension or diabetes
- Those with a history of syncope or vertigo attacks in the last 4 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Otago Exercise Group
Participants in the study were given group otago exercises for 4 weeks, face to face, once a week for 30 minutes.
They were also given brochures containing otago exercises twice a week and followed up remotely.
They were asked to walk normally for 30 minutes, 2 days a week.
Then they entered a 4-week cleansing period.
|
Group-based otago exercises were performed for 4 weeks.
They were also given a brochure containing otago exercises twice a week and applied individually and followed remotely.
They were asked to walk normally for 30 minutes twice a week.
They then entered a 4-week washout period.
|
|
Experimental: Dual Task Focused Otago Exercise Group
After a 4-week washout period, participants in the study were given group-based otago exercises and dual-task exercises once a week for 4 weeks.
They were given a brochure containing otago exercises including dual-task exercises twice a week and were applied individually and monitored remotely.
They were asked to walk normally 2 days a week.
|
After a 4-week washout period, face-to-face group-based and dual-task focused otago exercises were applied once a week for 4 weeks.
Participants were given a brochure containing otago exercises including dual-task exercises twice a week and applied individually and monitored remotely.
They were asked to walk normally for 30 minutes twice a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale
Time Frame: Duration of change in 4 week
|
It is a 17-question scale measuring fear of movement/re-injury.
|
Duration of change in 4 week
|
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Berg Balance Scale
Time Frame: Duration of change in 4 week
|
It is a scale that includes 14 different types of activities aimed at questioning dynamic and static balance.
|
Duration of change in 4 week
|
|
Geriatric Depression Scale Short Form
Time Frame: Duration of change in 4 week
|
It is a scale consisting of 15 questions that determines the level of depression in geriatric individuals.
|
Duration of change in 4 week
|
|
5 times sit and stand test
Time Frame: Duration of change in 4 week
|
Used to assess fall risk and lower extremity muscle strength.
|
Duration of change in 4 week
|
|
Mini Mental Status Test
Time Frame: Duration of change in 4 week
|
It is a scale used to assess cognitive function.
|
Duration of change in 4 week
|
|
Montreal Cognitive Assessment Test
Time Frame: Duration of change in 4 week
|
It is a scale used to identify individuals with mild cognitive impairment and to distinguish them from healthy geriatric individuals.
|
Duration of change in 4 week
|
|
Timed Up and Go Test
Time Frame: Duration of change in 4 week
|
It is a scale used to assess mobility in geriatric individuals.
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Duration of change in 4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2024
Primary Completion (Actual)
July 3, 2024
Study Completion (Actual)
August 8, 2024
Study Registration Dates
First Submitted
August 27, 2024
First Submitted That Met QC Criteria
August 27, 2024
First Posted (Actual)
August 29, 2024
Study Record Updates
Last Update Posted (Actual)
August 29, 2024
Last Update Submitted That Met QC Criteria
August 27, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GroupDualTaskOtagoExercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It will be evaluated if the researchers are contacted via their e-mail addresses.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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