NCT05248529

Brief Summary

This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 24, 2022

Last Update Submit

February 19, 2022

Conditions

Keywords

Roy Adaptation Modelhip arthroplastyknee arthroplastyphysical adaptationpreoperative education

Outcome Measures

Primary Outcomes (4)

  • Weight

    weight in kilograms. It was used to determine the body mass index.

    5 days

  • height

    height in meters. it was used to determine the body mass index.

    5 days

  • Body Mass Index

    Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.

    5 days

  • Systolic and diastolic blood pressure

    Both systolic and diastolic blood pressure is measured in units of millimeters of mercury (mmHg). It was used to determine the blood pressure of patients before mobilization.

    5 days

Secondary Outcomes (2)

  • The Observer Mobility Scale

    5 days

  • The Patient Mobility Scale

    5 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Within 12-24 hours before the surgery, the demonstrative education was given based on 'Hip Replacement Adaptation Booklet' and 'Knee Replacement Adaptation Booklet' to the patients in the intervention group.

Other: Education booklet

Control gorup

NO INTERVENTION

Routine preoperative preparation training was performed to the patients in the control group.

Interventions

Hip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge

Intervention group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • can read and write in Turkish A sufficient level of education to understand study procedures and training

You may not qualify if:

  • hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Merve Ozsoy Durmaz

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 24, 2022

First Posted

February 21, 2022

Study Start

November 1, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

An application for publication will be submitted in 2022.

Shared Documents
CSR
Time Frame
6 months
Access Criteria
studies on hip and knee arthroplasty

Locations