Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06070220 |
| Other study ID # |
E-53875521 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Saglik Bilimleri Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The current study was conducted to effectiveness of the Client-centered (CC) intervention
after Total Hip Arthroplasty (TKA). The current study was planned to examine the impact of
the CC intervention on quality of life, perceived occupational performance and satisfaction.
The current study was designed according to the CONSORT statement, which provides a
standardized method for randomized controlled trial (RCT) design. Approval for the study was
granted by the Local Ethics Committee. Written informed consent was obtained from all
participants prior to the study.
Description:
This study was designed to examine the effectiveness of 6-week CC intervention on quality of
life and perceived occupational performance and satisfaction level in individuals aged 65 and
over after THA. The study has a randomized controlled structure planned according to the
CONSORT Statement. Approval for the study was granted by the Local Ethics Committee. Written
informed consent was obtained from all participants prior to the study.
Participants To determine the number of samples, a power analysis, detailed in the
statistical analysis section, was performed and it was determined that there should be at
least 16 participants for each group. The study evaluated 41 older adults, considering the
inclusion and exclusion criteria, as well as predicting participants who would drop out of
the study for any reason during the intervention process. These 41 participants who were
admitted to a public university's occupational therapy department between July 2022 and July
2023 were screened.
According to the inclusion and exclusion criteria, one participant from each group was
excluded from the study because they participated in another rehabilitation program. The
remaining 39 participants were randomly assigned to either the CC group or the control group
using a computer-generated randomization technique. Initial evaluations were made of the
participants, who were divided into 20 participants in the CC group and 19 participants in
the control group. Afterwards, during the intervention process, 2 participants from the CC
group and 1 from the control group were excluded from the study because they could not
participate regularly.
Measurement The demographic characteristics of the participants were recorded, including age,
sex, education level, body mass index, smoking/alcohol use, operation region. On the other
hand, the following scales were used for all participants, both for use in the inclusion
criteria and to measure quality of life and perceived occupational performance and
satisfaction.
The scale used in the inclusion criteria:
Mini Mental State Examination In the inclusion criteria, Mini Mental State Examination used
to determine cognitive status consists of a maximum of 30 points. 24 points is considered the
threshold value, and scores of 24 and above indicate good cognitive skills. Turkish validity
and reliability studies of the test have been conducted and the researcher found the Mini
Mental State Examination positive and negative predictive values .90 and .95 respectively and
kappa score .86.
Scales used in the current study:
Nottingham Health Profile Nottingham Health Profile (NHP) is a 38-item quality of life survey
that measures individuals' perceived health problems and the extent to which these health
problems affect ADLs.
Canadian Occupational Performance Measure The Canadian Occupational Performance Measure
(COPM) was used to identify occupations where participants had problems with ADLs and to
determine the perceived occupational performance and satisfaction level in these occupations.
In the COPM, which was designed with the semi-structured interview method, firstly, the
occupations in which the participants experience problems in the areas of self-care,
productivity and free time are determined by giving importance points with a 1-10 Likert type
scoring system. Afterwards, a maximum of 5 occupations with the highest importance are
determined and the participants give performance and satisfaction scores to these occupations
using a 1-10 Likert type scoring method. The performance and satisfaction points given for
each occupation are summed and the performance and satisfaction points are divided by the
number of occupations received. As a result, participants' perceived occupational performance
and satisfaction scores are obtained. The Turkish adaptation performed and test re-test
reliability of Turkish version of COPM performance was .988 and satisfaction .986, indicating
excellent reliability.
Intervention
This program, which was created before discharge and applied to both groups, was created
using the literature. The following training procedure, which included exercise, transfer
activities and home arrangements, was followed in common in both groups:
1. st day: After the operation, exercises to strengthen the muscles of the participants
(thigh, hip and trunk muscles) were explained verbally and visually. Each exercise
consists of 3 sets of 12 repetitions. Exercises were updated in bed, sitting or
standing, depending on the participant's functional status, pain and fatigue.
Additionally, transfer activities training was provided:
Transfer Activities Training Considering the needs of the participants, a transfer
activities training program was created using the literature. This training program
teaches participants how to transfer on wet floors such as toilets and bathrooms, and
from one room to another, to beds, chairs, wheelchairs and sofas. Additionally, how to
go up and down stairs in a healthy way is explained.
2. nd day: The exercises taught to the participants on the first day were repeated.
Following these exercises, participants were given verbal instructions on gait training,
and then gait training began. According to the pain and fatigue status of the
participants, gait exercises were continued.
3. rd day: The work done on the first and second day was repeated. Pre-discharge home
arrangements training was provided:
Home arrangements training Home arrangements training was provided in order to eliminate
problems in areas of the house that are difficult to move and may cause injuries such as
living room, bathroom, toilet, kitchen, bedroom, corridor, stairs and to perform daily living
activities more independently. In this training home injuries and causes of falls, changes
that can be made at home, the use of assistive technology, the use of the right adaptive
equipment are explained. Home arrangement training to increase mobilization and prevent
various injuries such as the use of grab bars, arranging furniture, using adequate lighting
(such as using a photocell lamp in the hallway or increasing the light intensity), how to
prevent slipping on a wet floor, lifting door sills, moving carpets and cables, using ramps,
rearranging seats/chairs/beds to facilitate the transfer process information.
In addition, each participant was given a home visit after discharge and home arrangements
were made.
Client-centered intervention The CC intervention was planned to consist of 45-minute sessions
3 days a week for 6 weeks, after the first 4-day rehabilitation procedure given jointly both
group.
CC intervention is a dynamic approach that involves a systematic therapy process, that is, in
which the participant and the therapist are active in the treatment process. In the current
study, a treatment program was designed over a maximum of 5 occupations in which participants
evaluated after THA indicated problems in activities of daily living according to COPM. This
systematic and dynamic program consists of 4 phases: (1) client-centered goal setting, (2)
negotiating an intervention plan, (3) the actual intervention, (4) an evaluation of the
outcome and finally reporting to relevant others. A key factor in implementing this
intervention program is the problems and priorities prioritized for the participant. The
details of the intervention program are described below:
1. st stage: Occupations that cause performance problems in ADLs living should be
identified. Realistic and achievable goals for these problems should be designed. In
addition, it should be determined how these occupations are affected after THA.
2. nd stage: Brainstorming should be done for possible solutions to the problems
experienced in the occupations specified by the participants. Then the pros and cons of
the identified solutions should be evaluated.
3. rd stage: Once participants have decided on possible solutions, a plan should be made
and action taken. Adaptation of the occupation determined by COPM in terms of time,
place, person, how it is done, and the steps of the occupation (in accordance with
priority).
4. th stage: The participant should be informed about the progress of the CC intervention
and the participant's experiences. If necessary, the intervention should be updated by
consensus with the participant.
Statistical Analysis Statistical Package for the Social Sciences software (SPSS v. 28, IBM
Corporation, New York, NY, USA) was used for all statistical analyses. The level of
significance was set at P < 0.05 and the data are represented as mean±standart deviation. To
compare quality of life and occupational performance, an analysis of covariance (ANCOVA) was
performed using pre-test values as covariates and post-test values as dependent variables.
Before analyzing data, all assumptions of ANCOVA, including normality, homogeneity,
homogeneity of regression slopes, and linearity were checked and met. Partial et squared was
calculated to assess the effect size, following Cohen's classification where 0.01 represents
a small effect, 0.06 stands for a medium effect, and 0.14 indicates a large effect.
