Kinesiophobia and Fear of Falling After Femur Fracture

November 13, 2023 updated by: MAHİNUR DURMUŞ İSKENDER, Kastamonu University

The Effect of Mobilization Training on Kinesiophobia and Fear of Falling in Patients Undergoing Hip Arthroplasty After Femur Fracture

This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As a result of the changes that occur in old age, individuals face different problems and risks more frequently than the younger age group. One of the most important among these is falls, which cause high mortality and morbidity in this age group. Hip fractures that occur after a fall are the most distressing injuries that elderly individuals experience. Hip arthroplasty is one of the treatment methods preferred by patients who have hip fractures after a fall. After hip arthroplasty, elderly patients may avoid mobilization due to the fear of falling and damaging the prosthesis. This can lead to restriction of activities and a decrease in functional independence. This avoidance behavior increases with the fear of falling. Avoidance of movement due to fear of falling is defined as "kinesiophobia". Studies have stated that mobilization training before or after hip arthroplasty surgery is effective in postoperative mobilization. For this reason, it is thought that providing mobilization training to patients undergoing hip arthroplasty surgery will lead to more success in mobilization.

This study will be conducted as intervention research to determine the effect of mobilization training to be provided to the patient undergoing hip arthroplasty on postoperative kinesiophobia and fear of falling. The project will be carried out with 50 voluntary patients (25 intervention, 25 control) aged over 65 who came to Hospital for hip arthroplasty after femur fracture, can communicate, have no advanced sensory loss related to vision and hearing, do not have a psychiatric history, and will undergo hip arthroplasty surgery for the first time. Data will be collected using a "Sociodemographic Characteristics Questionnaire", the "Tampa Scale for Kinesiophobia", and "the Fall Activity Scale". Appropriate statistical methods will be used in the analysis of the data. Patients in the control group will be given routine care during the study. Patients in the experimental group will receive technology-assisted mobilization training in addition to routine care. Before mobilization, a training video loaded into a tablet will be given to patients. Written permission will be taken from the ethics committee and the institution for the implementation of the research and written consent will be obtained from the patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who will undergo hip prosthesis due to femur fracture after a fall,
  • Patients who were mobilized before falling,
  • Being over 65 years of age
  • Volunteering to participate in the research
  • No previous hip arthroplasty
  • Ability to read and write
  • There is no perception disorder or psychiatric disorder that would hinder communication.

Exclusion Criteria:

  • Having difficulty in communicating
  • Severe sensory loss related to vision and hearing

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Patients in the intervention group will be educated by watching videos on the first day after surgery, in addition to routine clinical education. On the 10th post-operative day, the patients will be called by the researcher and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered.
Other: MOBILIZATION TRAINING

Things to consider in the hospital in the early period after surgery: The first day in the hospital after surgery, the importance of the abduction pillow and early mobilization,

  • Exercises performed in bed in the early period after surgery: Exercises such as ankle pump, ankle rotation, bed-supported knee bending, hip contraction, opening exercise, thigh exercise, straight leg raise,
  • Early standing up: Activities such as sitting in bed or on a chair, standing up with the help of a walker, walking,
  • Exercises performed while standing: Exercises such as lifting the knee, opening the leg to the side,
  • Daily living activities: It will provide information on regulating ADLs such as bathing, dressing, using the toilet, getting into and driving the car, going up and down stairs, eating, sleeping, doing housework, sexual life, and information about the safety precautions that should be taken at home.
No Intervention: Control
The control group will receive routine clinical training. On the 10th post-operative day, the patients will be called by the researcher, and the "Tampa Kinesiophobia Scale" and "Fall Activity Scale" will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tampa Scale for Kinesiophobia
Time Frame: 10 days
Tampa Scale for Kinesiophobia is a 17-question checklist and is used for acute and chronic low back pain, fibromyalgia, and diseases associated with musculoskeletal injuries and whiplash. A 4-point Likert scoring (1 = Strongly disagree, 4 = Completely agree) is used in the scale. A total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has a high level of kinesiophobia. Permission was obtained from the researchers for the use of the scale.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kastamonu University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KastamonuU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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