Replacement, KneeNCT05187065
The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery
A study testing The mobile-based education and exercise program in people with Replacement, Knee, run by Alkay Kara at 1 site in Turkey (Türkiye).
Trial summary
Total knee replacement (TDP) surgery is recognized as an effective surgical option for patients who develop moderate to severe osteoarthritis of the knee. Before, during and after TDP surgery, patients experience physical, psychological and social problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Replacement, Knee
- What is being tested?
- The mobile-based education and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were decided to undergo total knee replacement surgery with the diagnosis of osteoarthritis,
- Patients who will undergo elective surgery
- Patients who will undergo unilateral total knee replacement surgery for the first time
- Patients who can be communicated verbally
- Patients without any psychiatric disease
- Patients who use smartphones and agree to participate in the study
Who cannot join
- Patients under the age of 18
- Patients who have had previous total knee replacement surgery
- Patients who underwent total knee replacement with emergency surgery
- Patients who will undergo bilateral total knee replacement surgery
- Patients with a previous psychiatric diagnosis
- Patients with verbal communication disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery on Anxiety, Kinesiophobia, and Physical Function
Total knee replacement (TDP) surgery is recognized as an effective surgical option for patients who develop moderate to severe osteoarthritis of the knee. Before, during and after TDP surgery, patients experience physical, psychological and social problems. After TDP surgery, patients may experience problems such as dependency and sleep problems in their daily living activities. Patients who have sleep problems, who cannot rest enough, become tired and experience anxiety as a result. It has been stated that the education given to the patients in the preoperative period reduces anxiety and analgesic needs and increases satisfaction. Progressive relaxation exercises in patients It has been shown to be effective in reducing symptoms such as anxiety, pain and fatigue. With the widespread use of mobile technologies, a rapid development is observed in mobile health applications and it is thought that its use in the field of health will provide great benefits to nursing services. This study is of the randomized controlled experimental type. During the application process, a mobile-based training and exercise program will be applied to the patients in the experimental group. As the education content, information about pre- and post-operative information and video-supported training content that will guide the patients with voice commands about the exercises that the patients will do before the surgery will be included in the mobile application. With the implementation of this program, continuity will be ensured by meeting the information needs of the patients before and after the surgery, and by performing progressive relaxation and knee exercises correctly and regularly. With the use of this mobile application, it is aimed to increase the physical functions of the patients by reducing the level of anxiety and fear of movement.
- Conditions
- Replacement, Knee
- Being tested
- The mobile-based education and exercise program
- Keywords
- Mobile based application, Progressive relaxation exercise, Knee exercise, Kinesiophobia, Patient Education, Physical Function, Sleep Quality, Pain, Nursing
- Medical subject headings
- Kinesiophobia, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mobile-based education and exercise programOther
Starting from the preoperative period, mobile-based patient education, progressive relaxation exercise and knee exercise program will be applied to the patient as a whole. Mobile-based education will include pre-operative and discharge education. The patient will be given a progressive relaxation exercise with the support of the mobile application and the exercises included in the knee exercise program that should be done after the surgery will be shown. Progressive relaxation exercises will be applied twice a day in the afternoon and evening. Postoperative knee exercises will be performed 3 to 5 times a day, depending on the type of exercise. These exercises will be continued regularly for up to 4 weeks after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based education and exercise program | Experimental | Mobile-based education and progressive relaxation and knee exercise program will be applied to the patients in the experimental group. Receives: Other: The mobile-based education and exercise program |
| Standard of care | No intervention | Mobile-based education and progressive relaxation and knee exercise program will not be applied to the patients in the control group, and the clinical routine will be maintained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Scale
The scale consists of two parts, a 20-item "state anxiety form" designed to determine what is felt at the moment, and a 20-item "trait anxiety form" designed to determine what is felt in general.
It is a four-degree scale ranging from "Not at all" to "Totally". Scores range from 20 (low anxiety) to 80 (high anxiety).
Measured: 4 weeks
Tampa Scale for Kinesiophobia
The scale consists of 17 items. The scale is a 4-point Likert type (1 = I strongly disagree, 4 = I completely agree) is used. The total score varies between 17-68. A high score on the scale indicates knesiophobia.
Measured: 4 weeks
Knee injury and osteoarthritis outcome score-physical function short-form
The KOOS-PS scale consists of seven items. The items are intended to measure the degree of functionality of normal daily activities and more challenging activities. Each item scores between 0 "no difficulty" and 4 "very severe difficulty". The raw score is the sum of the scores given to these seven questions and ranges from 0 to 28. Higher scores indicate worse physical function.
Measured: 4 weeks
Visual Analog Scale
The Visual Analog Scale is a widely used scale for the assessment of pain in patients. The patient marks his or her own pain on a 10 cm ruler with the words 'no pain' on one end and 'unbearable pain' on the other end.
Measured: 4 weeks
Visual Analog Sleep Scale
This Visual Analog Sleep Scale measures the sleep quality of individuals. Each item in the scale is evaluated on a chart between 0 (left end) and 100 (right end) using the visual comparison technique. Scale scoring ranges from 0 to 1000. An increase in the score obtained from the scale indicates a decrease in sleep quality.
Measured: 4 weeks
The Turkish Version of the Computer System Usability Questionnaire-Short Version
This questionnaire evaluates the usability of a software system with 13 items. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Feb 2022
- Primary completion28 Feb 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkay Kara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alkay Kara, Giresun University
- Investigators
- Neziha Karabulut, PhD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187065
- Sponsor's protocol ID
- A-KARA-001
- Status last verified
- Dec 2023
- First submitted
- 24 Dec 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery on Anxiety, Kinesiophobia, and Physical Function
- ClinicalTrials.gov ID
- NCT05187065
- Acronym / sponsor ID
- A-KARA-001
- Conditions
- Replacement, Knee
- Keywords
- Mobile based application, Progressive relaxation exercise, Knee exercise, Kinesiophobia, Patient Education, Physical Function, Sleep Quality, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Alkay KaraUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee replacement (TDP) surgery is recognized as an effective surgical option for patients who develop moderate to severe osteoarthritis of the knee. Before, during and after TDP surgery, patients experience physical, psychological and social problems. After TDP surgery, patients may experience problems such as dependency and sleep problems in their daily living activities. Patients who have sleep problems, who cannot rest enough, become tired and experience anxiety as a result. It has been stated that the education given to the patients in the preoperative period reduces anxiety and analgesic needs and increases satisfaction. Progressive relaxation exercises in patients It has been shown to be effective in reducing symptoms such as anxiety, pain and fatigue. With the widespread use of mobile technologies, a rapid development is observed in mobile health applications and it is thought that its use in the field of health will provide great benefits to nursing services. This study is of the randomized controlled experimental type. During the application process, a mobile-based training and exercise program will be applied to the patients in the experimental group. As the education content, information about pre- and post-operative information and video-supported training content that will guide the patients with voice commands about the exercises that the patients will do before the surgery will be included in the mobile application. With the implementation of this program, continuity will be ensured by meeting the information needs of the patients before and after the surgery, and by performing progressive relaxation and knee exercises correctly and regularly. With the use of this mobile application, it is aimed to increase the physical functions of the patients by reducing the level of anxiety and fear of movement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile-based education and exercise program | Experimental | Other: The mobile-based education and exercise programMobile-based education and progressive relaxation and knee exercise program will be applied to the patients in the experimental group. |
| Standard of care | No intervention | –Mobile-based education and progressive relaxation and knee exercise program will not be applied to the patients in the control group, and the clinical routine will be maintained. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who were decided to undergo total knee replacement surgery with the diagnosis of osteoarthritis,
- Patients who will undergo elective surgery
- Patients who will undergo unilateral total knee replacement surgery for the first time
- Patients who can be communicated verbally
- Patients without any psychiatric disease
Key exclusion criteria (6 listed)
- Patients under the age of 18
- Patients who have had previous total knee replacement surgery
- Patients who underwent total knee replacement with emergency surgery
- Patients who will undergo bilateral total knee replacement surgery
- Patients with a previous psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The mobile-based education and exercise programStarting from the preoperative period, mobile-based patient education, progressive relaxation exercise and knee exercise program will be applied to the patient as a whole. Mobile-based education will include pre-operative and discharge education. The patient will be given a progressive relaxation exercise with the support of the mobile application and the exercises included in the knee exercise program that should be done after the surgery will be shown. Progressive relaxation exercises will be applied twice a day in the afternoon and evening. Postoperative knee exercises will be performed 3 to 5 times a day, depending on the type of exercise. These exercises will be continued regularly for up to 4 weeks after discharge. | Other | Mobile-based education and exercise program |
Primary outcome
State-Trait Anxiety Scale
Time frame: 4 weeks
The scale consists of two parts, a 20-item "state anxiety form" designed to determine what is felt at the moment, and a 20-item "trait anxiety form" designed to determine what is felt in general. It is a four-degree scale ranging from "Not at all" to "Totally". Scores range from 20 (low anxiety) to 80 (high anxiety).
Tampa Scale for Kinesiophobia
Time frame: 4 weeks
The scale consists of 17 items. The scale is a 4-point Likert type (1 = I strongly disagree, 4 = I completely agree) is used. The total score varies between 17-68. A high score on the scale indicates knesiophobia.
Knee injury and osteoarthritis outcome score-physical function short-form
Time frame: 4 weeks
The KOOS-PS scale consists of seven items. The items are intended to measure the degree of functionality of normal daily activities and more challenging activities. Each item scores between 0 "no difficulty" and 4 "very severe difficulty". The raw score is the sum of the scores given to these seven questions and ranges from 0 to 28. Higher scores indicate worse physical function.
Visual Analog Scale
Time frame: 4 weeks
The Visual Analog Scale is a widely used scale for the assessment of pain in patients. The patient marks his or her own pain on a 10 cm ruler with the words 'no pain' on one end and 'unbearable pain' on the other end.
Visual Analog Sleep Scale
Time frame: 4 weeks
This Visual Analog Sleep Scale measures the sleep quality of individuals. Each item in the scale is evaluated on a chart between 0 (left end) and 100 (right end) using the visual comparison technique. Scale scoring ranges from 0 to 1000. An increase in the score obtained from the scale indicates a decrease in sleep quality.
The Turkish Version of the Computer System Usability Questionnaire-Short Version
Time frame: 4 weeks
This questionnaire evaluates the usability of a software system with 13 items. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neziha Karabulut, PhD study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The mobile-based education and exercise program in people with Replacement, Knee, run by Alkay Kara at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Scale (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.