NCT05655871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

December 9, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

Nursing homeRisk of fallingElderly individuals

Outcome Measures

Primary Outcomes (2)

  • 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.

    Three weeks

  • Exercise Stages of Change Scale

    It consists of 5 stages: not thinking, thinking, preparing, acting and continuing.

    Three weeks

Secondary Outcomes (3)

  • Exercise Change Process Scale

    1st week, 9th week and 12th week

  • Exercise Decision Making Scale

    1st week, 9th week and 12th week

  • Exercise Self-Efficacy Scale

    1st week, 9th week and 12th week

Study Arms (2)

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".

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.

Other: Standard Maintenance Practice

Interventions

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.

Enterprise Group

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.

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu University

Kastamonu, Tosya, 37500, Turkey (Türkiye)

Location

Study Officials

  • Ayşe Özdemir, Instructor

    PhD Thesis Student

    PRINCIPAL INVESTIGATOR
  • Ayla Demirtaş, Associate professor

    PhD Thesis Advisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
When creating groups in the study, the participants learned which group they belonged to, and blinding was done when the data was sent to the statistician for analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two groups in the study, these are control and intervention groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 19, 2022

Study Start

September 15, 2022

Primary Completion

December 16, 2022

Study Completion

January 6, 2023

Last Updated

December 19, 2022

Record last verified: 2022-12

Locations