Clinical trial NCT05655871: The Effect of Nurse-led Transtheoretical Model-Based Video Exercise Trainings on Fall Risk to Elderly People Living in Nursing Homes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk of Falling in the Elderly
Keywords: Nursing home
Risk of falling
Elderly individuals
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups in the study, these are control and intervention groups.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Tinetti Balance and Gait Test
timeFrame: Three weeks
measure: Exercise Stages of Change Scale
timeFrame: Three weeks
Secondary outcomes:
measure: Exercise Change Process Scale
timeFrame: 1st week, 9th week and 12th week
measure: Exercise Decision Making Scale
timeFrame: 1st week, 9th week and 12th week
measure: Exercise Self-Efficacy Scale
timeFrame: 1st week, 9th week and 12th week
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Kastamonu University
state: Tosya
Study officials:
affiliation: PhD Thesis Student
name: Ayşe Özdemir, Instructor
role: PRINCIPAL_INVESTIGATOR
affiliation: PhD Thesis Advisor
name: Ayla Demirtaş, Associate professor
role: STUDY_DIRECTOR
References: