Risk of Falling in the ElderlyNCT05655871
The Effect of Nurse-led Transtheoretical Model-Based Video Exercise Trainings on Fall Risk to Elderly People Living in Nursing Homes
A study testing Transtheoretic Model Based Video Exercise Training and Standard Maintenance Practice in people with Risk of Falling in the Elderly, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Risk of Falling in the Elderly
- What is being tested?
- Transtheoretic Model Based Video Exercise Training and Standard Maintenance Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 6 Jan 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 and over who volunteered to participate in the research
- Those with a Mini Mental Test (MMT) score ≥24
- Those with a KATZ daily living activities scale score of 6
- Does not have a cognitive/affective problem that may hinder communication
Who cannot join
- Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
- The individual's desire to leave the research
- The individual has a condition that requires hospitalization
- The individual does not participate in video exercise trainings three times a week in a row.
- Death of the individual
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Nurse-led Transtheoretical Model-Based Video Exercise Trainings on Fall Risk to Elderly People Living in a Nursing Home
The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.
Read the detailed description
The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.
This study was designed as a randomized controlled experiment. The population of the research consists of individuals aged 65 and over living in Tosya Nursing Home Elderly Care and Rehabilitation Center.
Sample size was calculated using the "G.Power-3.1.9.2" program at a 95% confidence level. As a result of the analysis, α=0.05, standardized effect size was taken from Cohen for the analysis of variance in repeated measurements with factor, due to the lack of a previous study, with a theoretical power of 0.25 to 0.95, the minimum sample size was 36 people in total, 18 control subjects. It was calculated as 18 intervention groups. However, considering that there may be data losses in the study, it was planned to recruit a total of 44 people, 22 of whom were in the control group and 22 in the intervention group, who met the inclusion criteria.
Inclusion criteria in the study
- Individuals aged 65 and over who volunteered to participate in the research
- Those with a Mini Mental Test (MMT) score ≥24
- Those with a KATZ daily living activities scale score of 6
- Does not have a cognitive/affective problem that may hinder communication Exclusion criteria from the study
- Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
- The individual's desire to leave the research
- The individual has a condition that requires hospitalization
- The individual does not participate in video exercise trainings three times a week in a row.
- Death of the individual Simple randomization method was used while forming intervention and control groups in our study. In this randomization method, individuals who meet the inclusion criteria can be assigned to the groups completely randomly, with equal probability, and independently of the previous assignment, after participating in the study. Computer-assisted randomization method was used in simple randomization. For this method, the https://www.randomizer.org/ page was used and intervention and control groups were created.
Data in the research; "Standardized Mini Mental Test", "Modified Mini Mental Test for the Untrained", "KATZ Activities of Daily Living Scale", "Personal Information Form", "Tinetti Balance and Gait Test", "Exercise Change Stages Scale", "Exercise Change Process" Scale", "Exercise Decision-Making Scale", "Exercise Self-Efficacy Scale".
Before starting the research, all the elderly were invited to the nursing home seminar hall to give information about the research by meeting with the Nursing Home Director. The first interview was held with elderly individuals who could come to the seminar hall. In the first interview, information about the research was given and the compliance of the individuals with the inclusion criteria was evaluated. Written and verbal consents were obtained from the elderly individuals who met the inclusion criteria and agreed to participate in the study.
Data collection forms were applied to the intervention group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". Elderly individuals were divided into 5 groups according to the stages of change in the TTM scale (not thinking, thinking, preparation, movement, and continuation). According to the change phase, those in the non-thinking phase are at 10:00 on Mondays, Wednesdays and Fridays, those in the thinking phase are at 13:00 on Mondays, Wednesdays and Fridays, and those in the preparatory phase are at 15:00 on Mondays, Wednesdays and Fridays of the week. They were asked to come to the seminar hall at 00:00. It was explained that a training video about physical activity would be watched. Those in the preparation phase were asked to come to the activity hall at 10:00 on Tuesdays, Thursdays and Saturdays of the week, and at 14:00 on Tuesdays, Thursdays and Saturdays of the week, while wearing their comfortable clothes. It was said that a training and motivational video about physical activity would be watched and the exercises would be done under the supervision of the researcher with the "show-and-make technique". Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. Participants 10-12. No application will be made between weeks and the last test will be done in the 12th week.
Data collection forms were applied to the control group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. The final test will be done at week 12. In order to avoid an ethical dilemma between the individuals in the control and intervention groups, the videos will be watched by the individuals in the control group at the end of the study.
- Conditions
- Risk of Falling in the Elderly
- Being tested
- Transtheoretic Model Based Video Exercise Training, Standard Maintenance Practice
- Keywords
- Nursing home, Risk of falling, Elderly individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtheoretic Model Based Video Exercise TrainingOther
Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. Participants 10-12. No application will be made between weeks and the last test will be done in the 12th week.
Standard Maintenance PracticeOther
Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. The final test will be done at week 12.
| Study group | Role | What they receive |
|---|---|---|
| Enterprise Group | Experimental | Elderly individuals were divided into 5 groups according to the stages of change in the TTM scale. According to the change phase, those in the non-thinking phase are at 10:00 on Mondays, Wednesdays and Fridays, those in the thinking phase are at 13:00 on Mondays, Wednesdays and Fridays, and those in the preparatory phase are at 15:00 on Mondays, Wednesdays and Fridays of the week. They were asked to come to the seminar hall at 00:00. It was explained that a training video about physical activity would be watched. Those in the preparation phase were asked to come to the activity hall at 10:00 on Tuesdays, Thursdays and Saturdays of the week, and at 14:00 on Tuesdays, Thursdays and Saturdays of the week, while wearing their comfortable clothes. It was said that a training and motivational video about physical activity would be watched and the exercises would be done under the supervision of the researcher with the "show-and-make technique". Receives: Other: Transtheoretic Model Based Video Exercise Training |
| Control Group | Experimental | Data collection forms were applied to the control group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". In order to avoid an ethical dilemma between the individuals in the control and intervention groups, the videos will be watched by the individuals in the control group at the end of the study. Receives: Other: Standard Maintenance Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti Balance and Gait Test
Three values are given in the scoring of the Tinetti Balance and Gait Test, 0 -1-2. 0 points represents the maximum impairment (not being able to perform the movement), 1 point represents the adaptation of the specified movement, 2 points independence (the movement is done as desired). Individual scores are then combined to form three measures, the overall gait assessment score, the overall balance assessment score, and the sum of the gait and balance scores. The maximum score that can be obtained for the walking assessment is 12. The maximum score that can be obtained for the balance assessment is 16. The maximum total score that can be obtained from the Tinetti Balance and Gait Test is 28. In general, a total score of ≤18 indicates a high risk of falling, a range of 19-24 indicates a medium fall risk and a score of ≥24 indicates a low risk of falling.
Measured: Three weeks
Exercise Stages of Change Scale
It consists of 5 stages: not thinking, thinking, preparing, acting and continuing.
Measured: Three weeks
Secondary outcomes (3)
Exercise Change Process Scale
The scale of the change process; It is a 40-item scale consisting of 10 sub-dimensions, five of which are cognitive processes and five are behavioral processes. The five-point Likert scale evaluates the previous month. The items of the scale range from one to five points. While the highest score that can be obtained from the scale is 200, the lowest score is 40. An increase in the scale score indicates that individuals progress positively in the exercise change process.
Measured: 1st week, 9th week and 12th week
Exercise Decision Making Scale
The scale, which consists of 16 questions, is a five-point Likert type. The first 10 questions measure the perception of benefit, while the last six questions measure the perception of harm. While the lowest score that can be taken from the perception of benefit sub-dimension of the decision-making scale is 10 and the highest score is 50, the lowest score that can be obtained from the perception of harm sub-dimension is 6 and the highest score is 30. In order for the individual to be successful in change, it is expected that the benefit perception score will increase and the harm perception score will decrease.
Measured: 1st week, 9th week and 12th week
Exercise Self-Efficacy Scale
Exercise self-efficacy scale is five-item and five-point Likert type. The highest score that can be obtained from the scale is 25, and the lowest score is 5. The increase in the scale score indicates that the individuals' self-efficacy for exercising has improved.
Measured: 1st week, 9th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start15 Sep 2022
- Primary completion16 Dec 2022 (estimated)
- Study completion6 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Falling in the ElderlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in the study, these are control and intervention groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Ozdemir, Kastamonu University
- Investigators
- Ayşe Özdemir, Instructor, Principal investigator, PhD Thesis StudentAyla Demirtaş, Associate professor, Study director, PhD Thesis Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655871
- Sponsor's protocol ID
- KU-AÖ-01
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Nurse-led Transtheoretical Model-Based Video Exercise Trainings on Fall Risk to Elderly People Living in a Nursing Home
- ClinicalTrials.gov ID
- NCT05655871
- Acronym / sponsor ID
- KU-AÖ-01
- Conditions
- Risk of Falling in the Elderly
- Keywords
- Nursing home, Risk of falling, Elderly individuals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 16 Dec 2022 (estimated)
- Study completion
- 6 Jan 2023 (estimated)
- First posted
- 19 Dec 2022 (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.
The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.
Detailed description
The aim of this study is to examine the effect of video exercise trainings based on transtheoretic model given to elderly individuals living in nursing homes under the leadership of nurses on the risk of falling in elderly individuals within nursing care programs.
This study was designed as a randomized controlled experiment. The population of the research consists of individuals aged 65 and over living in Tosya Nursing Home Elderly Care and Rehabilitation Center.
Sample size was calculated using the "G.Power-3.1.9.2" program at a 95% confidence level. As a result of the analysis, α=0.05, standardized effect size was taken from Cohen for the analysis of variance in repeated measurements with factor, due to the lack of a previous study, with a theoretical power of 0.25 to 0.95, the minimum sample size was 36 people in total, 18 control subjects. It was calculated as 18 intervention groups. However, considering that there may be data losses in the study, it was planned to recruit a total of 44 people, 22 of whom were in the control group and 22 in the intervention group, who met the inclusion criteria.
Inclusion criteria in the study
- Individuals aged 65 and over who volunteered to participate in the research
- Those with a Mini Mental Test (MMT) score ≥24
- Those with a KATZ daily living activities scale score of 6
- Does not have a cognitive/affective problem that may hinder communication Exclusion criteria from the study
- Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
- The individual's desire to leave the research
- The individual has a condition that requires hospitalization
- The individual does not participate in video exercise trainings three times a week in a row.
- Death of the individual Simple randomization method was used while forming intervention and control groups in our study. In this randomization method, individuals who meet the inclusion criteria can be assigned to the groups completely randomly, with equal probability, and independently of the previous assignment, after participating in the study. Computer-assisted randomization method was used in simple randomization. For this method, the https://www.randomizer.org/ page was used and intervention and control groups were created.
Data in the research; "Standardized Mini Mental Test", "Modified Mini Mental Test for the Untrained", "KATZ Activities of Daily Living Scale", "Personal Information Form", "Tinetti Balance and Gait Test", "Exercise Change Stages Scale", "Exercise Change Process" Scale", "Exercise Decision-Making Scale", "Exercise Self-Efficacy Scale".
Before starting the research, all the elderly were invited to the nursing home seminar hall to give information about the research by meeting with the Nursing Home Director. The first interview was held with elderly individuals who could come to the seminar hall. In the first interview, information about the research was given and the compliance of the individuals with the inclusion criteria was evaluated. Written and verbal consents were obtained from the elderly individuals who met the inclusion criteria and agreed to participate in the study.
Data collection forms were applied to the intervention group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". Elderly individuals were divided into 5 groups according to the stages of change in the TTM scale (not thinking, thinking, preparation, movement, and continuation). According to the change phase, those in the non-thinking phase are at 10:00 on Mondays, Wednesdays and Fridays, those in the thinking phase are at 13:00 on Mondays, Wednesdays and Fridays, and those in the preparatory phase are at 15:00 on Mondays, Wednesdays and Fridays of the week. They were asked to come to the seminar hall at 00:00. It was explained that a training video about physical activity would be watched. Those in the preparation phase were asked to come to the activity hall at 10:00 on Tuesdays, Thursdays and Saturdays of the week, and at 14:00 on Tuesdays, Thursdays and Saturdays of the week, while wearing their comfortable clothes. It was said that a training and motivational video about physical activity would be watched and the exercises would be done under the supervision of the researcher with the "show-and-make technique". Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. Participants 10-12. No application will be made between weeks and the last test will be done in the 12th week.
Data collection forms were applied to the control group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". Initial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. The final test will be done at week 12. In order to avoid an ethical dilemma between the individuals in the control and intervention groups, the videos will be watched by the individuals in the control group at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups in the study, these are control and intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Enterprise Group | Experimental | Other: Transtheoretic Model Based Video Exercise TrainingElderly individuals were divided into 5 groups according to the stages of change in the TTM scale. According to the change phase, those in the non-thinking phase are at 10:00 on Mondays, Wednesdays and Fridays, those in the thinking phase are at 13:00 on Mondays, Wednesdays and Fridays, and those in the preparatory phase are at 15:00 on Mondays, Wednesdays and Fridays of the week. They were asked to come to the seminar hall at 00:00. It was explained that a training video about physical activity would be watched. Those in the preparation phase were asked to come to the activity hall at 10:00 on Tuesdays, Thursdays and Saturdays of the week, and at 14:00 on Tuesdays, Thursdays and Saturdays of the week, while wearing their comfortable clothes. It was said that a training and motivational video about physical activity would be watched and the exercises would be done under the supervision of the researcher with the "show-and-make technique". |
| Control Group | Experimental | Other: Standard Maintenance PracticeData collection forms were applied to the control group in the pre-test. These forms are; "Personal Information Form, Tinetti Balance and Gait Test, Exercise Change Stages Scale, Exercise Change Process Scale, Exercise Decision-Making Scale, Exercise Self-Efficacy Scale". In order to avoid an ethical dilemma between the individuals in the control and intervention groups, the videos will be watched by the individuals in the control group at the end of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Individuals aged 65 and over who volunteered to participate in the research
- Those with a Mini Mental Test (MMT) score ≥24
- Those with a KATZ daily living activities scale score of 6
- Does not have a cognitive/affective problem that may hinder communication
Key exclusion criteria (5 listed)
- Those who have a chronic disease and cannot control it with medication (Individuals will be followed in their files.) Exclusion criteria
- The individual's desire to leave the research
- The individual has a condition that requires hospitalization
- The individual does not participate in video exercise trainings three times a week in a row.
- Death of the individual
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 |
|---|---|---|
| Transtheoretic Model Based Video Exercise TrainingInitial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. Participants 10-12. No application will be made between weeks and the last test will be done in the 12th week. | Other | Enterprise Group |
| Standard Maintenance PracticeInitial follow-up 1-3. Between weeks 4-6, the second follow-up. Between weeks 7-9, the third follow-up. was done within weeks. The final test will be done at week 12. | Other | Control Group |
Primary outcome
Tinetti Balance and Gait Test
Time frame: Three weeks
Three values are given in the scoring of the Tinetti Balance and Gait Test, 0 -1-2. 0 points represents the maximum impairment (not being able to perform the movement), 1 point represents the adaptation of the specified movement, 2 points independence (the movement is done as desired). Individual scores are then combined to form three measures, the overall gait assessment score, the overall balance assessment score, and the sum of the gait and balance scores. The maximum score that can be obtained for the walking assessment is 12. The maximum score that can be obtained for the balance assessment is 16. The maximum total score that can be obtained from the Tinetti Balance and Gait Test is 28. In general, a total score of ≤18 indicates a high risk of falling, a range of 19-24 indicates a medium fall risk and a score of ≥24 indicates a low risk of falling.
Exercise Stages of Change Scale
Time frame: Three weeks
It consists of 5 stages: not thinking, thinking, preparing, acting and continuing.
3 secondary outcomes
Exercise Change Process Scale
Time frame: 1st week, 9th week and 12th week
Exercise Decision Making Scale
Time frame: 1st week, 9th week and 12th week
Exercise Self-Efficacy Scale
Time frame: 1st week, 9th week and 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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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.
Ayşe Özdemir, Instructor principal investigator
PhD Thesis Student
Ayla Demirtaş, Associate professor study director
PhD Thesis Advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtheoretic Model Based Video Exercise Training and Standard Maintenance Practice in people with Risk of Falling in the Elderly, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Tinetti Balance and Gait Test (time frame: Three weeks). The study lists 2 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 19 Dec 2022.