Knee ArthropathyNCT06159205
Core Stability Via Telerehabitation on TKA
A study testing standard exercises and core stability exercises in people with Knee Arthropathy and Telerehabilitation, run by Burdur Mehmet Akif Ersoy University at 2 sites in Turkey (Türkiye).
Trial summary
Objective: To investigate the effects of core stability exercises (CSE) added to the standard exercises (SE) on patient-reported (PR) and performance-based (PB) outcomes in patients with total knee arthroplasty (TKA) followed with telerehabilitation (TR). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Arthropathy, Telerehabilitation
- What is being tested?
- standard exercises and core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 17 Feb 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be over 18 years old
- Undergoing primary unilateral TKA
- To be able to understand, speak and write Turkish,
- be able to understand verbal and written information, have internet access
- be able to use a video conferencing program
Who cannot join
- To undergo revision TKA
- To have undergone any major surgery on the lower extremities
- Comorbid diseases such as rheumatoid arthritis, cancer, etc,
- Neurological disease causing functional disability
- Have a diagnosed psychiatric disorder
- Being addicted to alcohol or drugs
Show all 9Show fewer
- Have a hearing or visual impairment that cannot be corrected with hearing aids or glasses,
- Being morbidly obese (BMI>40 kg/m2)
- be unable to participate in a twelve-week rehabilitation program
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Burdur Mehmet Akif Ersoy University
Burdur, 15100
Pamukkale University
Denizli, 20070
About this study
Official title: Investigation of the Effects of Core Stability Exercises Added to the Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Total Knee Arthroplasty Patients Followed With Telerehabilitation
Objective: To investigate the effects of core stability exercises (CSE) added to the standard exercises (SE) on patient-reported (PR) and performance-based (PB) outcomes in patients with total knee arthroplasty (TKA) followed with telerehabilitation (TR).
Methods: The 42 patients who participated in the study were randomly divided into 2 groups [group 1: SE (n= 21), group 2: SE + CSE (n= 21)]. The first 8 weeks of the post-discharge follow-up were performed by videoconference-based TR under the supervision of a physiotherapist and the last 4 weeks by telephone-based TR. Functional level was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain intensity by Visual Analog Scale (VAS), affected knee range of motion (ROM) by Copenhagen Knee Range of Motion Scale (CKRS), quality of life by Short Form-12 (SF-12) and World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF), lower extremity muscle strength by 30-seconds Chair-Stand Test and locomotor performance by Stair Climb Test. Assessments were performed with TR preoperatively and at the first, second and third post-op months.
Read the detailed description
At the beginning of the study, an exercise booklet and exercise videos were prepared to be followed throughout the follow-up period. Subsequently, a telerehabilitation (TR) system was established using a laptop computer, a smartphone and a camera as hardware and WhatsApp® and Zoom® applications as software. The surgeries of all patients participating in the study were performed by the same surgical team with fast-track surgical procedure. Until discharge (1 day), a standard physiotherapy and rehabilitation (PTR) program consisting of range of motion and strengthening exercises, cold application, weight transfer and walking training was applied to both groups of patients. At the time of discharge, each patient was given an exercise booklet according to the intervention group.
During the follow-up period, only the interventions included in the standard exercise (SE) program were applied to the SE group, while interventions included in both the SE and core stability exercise (CSE) program were applied to the SE + CSE group. In addition to the TR sessions, each patient performed the interventions belonging to the group they were included in as a home program (HP), 3 sessions per day for the first 8 weeks of the follow-up period. Patient follow-up, which started from the 1st week after discharge, continued for 12 weeks. The content of the follow-up process was planned to include information, assessment, and PTR interventions. The first 8 weeks of the follow-up period consisted of PTR sessions performed with video-conference-based TR method under the supervision of a physiotherapist and HP, while the last 4 weeks consisted of the follow-up of the walking program performed with telephone-based TR method.
- Conditions
- Knee Arthropathy, Telerehabilitation
- Being tested
- standard exercises, core stability exercises
- Keywords
- total knee arthroplasty, exercise, core stability, telerehabilitation, physiotherapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard exercisesOther
Standard exercises for TKA patients.
core stability exercisesOther
Core stability exercises for TKA patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: SE Group | Experimental | SE: standard exercises During the follow-up period, only the interventions included in the standard exercise program were applied to the SE Group. Receives: Other: standard exercises |
| Group 2: SE + CSE Group | Experimental | CSE: core stability exercises During the follow-up period interventions included in both the standard and core stability program were applied to the SE + CSE group. Receives: Other: standard exercises; Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional level
Functional level was assessed using the Western Ontario McMaster University Osteoarthritis Index. Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions and 3 subcategories (pain, stiffness and physical function). Pain is evaluated with 5 questions, stiffness with 2 questions and physical function with 17 questions. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The total score can be a minimum of 0 and a maximum of 100. In addition, each subcategory can also be evaluated on its own. A higher score on the Index indicates more symptoms and physical disability.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Pain intensity
Pain intensity was assessed using the pain subcategory of Western Ontario McMaster University Osteoarthritis Index and the Visual Analog Scale. There are 5 questions in the pain subcategory of the Western Ontario and McMaster Universities Osteoarthritis Index. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The pain score can be a minimum of 0 and a maximum of 20. A higher pain score indicates more pain. Visual Analog Scale consists of a horizontal 10 cm straight line. When viewed from left to right, there is a value of 0 at the beginning and 10 at the end of the line. The 0 point of the line indicates no pain and the 10 point indicates the most severe pain felt in life.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Knee range of motion
Knee range of motion was assessed using the Copenhagen Knee Range of Motion Scale. In this scale, knee range of motion is assessed based on illustrations. For the knee joint flexion angle, 6 different illustrations are used: 60°, 75°, 90°, 105°, 120° and 135°. For the knee extension angle, 5 different illustrations are used: 45°, 30°, 15°, 0° and -15°.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Health-related quality of life
Health-related quality of life was assessed with the Short Form-12. In the Short Form-12, the physical component summary-12 score is obtained from the physical functioning, physical role, body pain and general health sub-dimensions, while the mental component summary-12 score is obtained from the vitality, social functioning, emotional role and mental health sub-dimensions. Both physical component summary-12 and mental component summary-12 scores range between 0-100, with higher scores indicating better health status.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
General quality of life
General quality of life was assessed with the World Health Organization Quality of Life Brief Version. World Health Organization Quality of Life Brief Version consists of 4 domains: physical health, psychological, social relationships and environment. In World Health Organization Quality of Life Brief Version, each domain is scored separately and expressed as a percentage between 0 and 100, with a higher percentage indicating better health.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Lower extremity muscle strength
Lower extremity muscle strength was assessed with the 30-seconds chair-stand test. The number of times the patient stands up completely from the chair within 30 seconds is recorded as the patient's score.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Locomotor performance
Locomotor performance was assessed with the stair climb test. The time taken to ascend and then descend a 9-step staircase was recorded as the patient's score.
Measured: The assessments were performed before surgery and at the first, second and third months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Sep 2021
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a double-blind, randomised controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Akın Süzer, Burdur Mehmet Akif Ersoy University
- Investigators
- Akın Süzer, PT, PhD, Principal investigator, Burdur Mehmet Akif Ersoy UniversityNihal Büker, PT, PhD, Study director, Pamukkale UniversityHarun R Güngör, MD, PhD, Principal investigator, Pamukkale UniversityNusret Ök, MD, PhD, Principal investigator, Pamukkale UniversityRaziye Şavkın, PT, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159205
- Sponsor's protocol ID
- ErsoyU.E-60116787-020-90137
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Core Stability Exercises Added to the Standard Exercise Program on Patient-Reported and Performance-Based Outcomes in Total Knee Arthroplasty Patients Followed With Telerehabilitation
- ClinicalTrials.gov ID
- NCT06159205
- Acronym / sponsor ID
- ErsoyU.E-60116787-020-90137
- Conditions
- Knee Arthropathy, Telerehabilitation
- Keywords
- total knee arthroplasty, exercise, core stability, telerehabilitation, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 6 Dec 2023 (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.
Objective: To investigate the effects of core stability exercises (CSE) added to the standard exercises (SE) on patient-reported (PR) and performance-based (PB) outcomes in patients with total knee arthroplasty (TKA) followed with telerehabilitation (TR).
Methods: The 42 patients who participated in the study were randomly divided into 2 groups [group 1: SE (n= 21), group 2: SE + CSE (n= 21)]. The first 8 weeks of the post-discharge follow-up were performed by videoconference-based TR under the supervision of a physiotherapist and the last 4 weeks by telephone-based TR. Functional level was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pain intensity by Visual Analog Scale (VAS), affected knee range of motion (ROM) by Copenhagen Knee Range of Motion Scale (CKRS), quality of life by Short Form-12 (SF-12) and World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF), lower extremity muscle strength by 30-seconds Chair-Stand Test and locomotor performance by Stair Climb Test. Assessments were performed with TR preoperatively and at the first, second and third post-op months.
Detailed description
At the beginning of the study, an exercise booklet and exercise videos were prepared to be followed throughout the follow-up period. Subsequently, a telerehabilitation (TR) system was established using a laptop computer, a smartphone and a camera as hardware and WhatsApp® and Zoom® applications as software. The surgeries of all patients participating in the study were performed by the same surgical team with fast-track surgical procedure. Until discharge (1 day), a standard physiotherapy and rehabilitation (PTR) program consisting of range of motion and strengthening exercises, cold application, weight transfer and walking training was applied to both groups of patients. At the time of discharge, each patient was given an exercise booklet according to the intervention group.
During the follow-up period, only the interventions included in the standard exercise (SE) program were applied to the SE group, while interventions included in both the SE and core stability exercise (CSE) program were applied to the SE + CSE group. In addition to the TR sessions, each patient performed the interventions belonging to the group they were included in as a home program (HP), 3 sessions per day for the first 8 weeks of the follow-up period. Patient follow-up, which started from the 1st week after discharge, continued for 12 weeks. The content of the follow-up process was planned to include information, assessment, and PTR interventions. The first 8 weeks of the follow-up period consisted of PTR sessions performed with video-conference-based TR method under the supervision of a physiotherapist and HP, while the last 4 weeks consisted of the follow-up of the walking program performed with telephone-based TR method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a double-blind, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Group 1: SE Group | Experimental | Other: standard exercisesSE: standard exercises During the follow-up period, only the interventions included in the standard exercise program were applied to the SE Group. |
| Group 2: SE + CSE Group | Experimental | Other: standard exercises, Other: core stability exercisesCSE: core stability exercises During the follow-up period interventions included in both the standard and core stability program were applied to the SE + CSE group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be over 18 years old
- Undergoing primary unilateral TKA
- To be able to understand, speak and write Turkish,
- be able to understand verbal and written information, have internet access
- be able to use a video conferencing program
Key exclusion criteria (9 listed)
- To undergo revision TKA
- To have undergone any major surgery on the lower extremities
- Comorbid diseases such as rheumatoid arthritis, cancer, etc,
- Neurological disease causing functional disability
- Have a diagnosed psychiatric disorder
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 |
|---|---|---|
| standard exercisesStandard exercises for TKA patients. | Other | Group 1: SE Group, Group 2: SE + CSE Group |
| core stability exercisesCore stability exercises for TKA patients. | Other | Group 2: SE + CSE Group |
Primary outcome
Functional level
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Functional level was assessed using the Western Ontario McMaster University Osteoarthritis Index. Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions and 3 subcategories (pain, stiffness and physical function). Pain is evaluated with 5 questions, stiffness with 2 questions and physical function with 17 questions. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The total score can be a minimum of 0 and a maximum of 100. In addition, each subcategory can also be evaluated on its own. A higher score on the Index indicates more symptoms and physical disability.
Pain intensity
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Pain intensity was assessed using the pain subcategory of Western Ontario McMaster University Osteoarthritis Index and the Visual Analog Scale. There are 5 questions in the pain subcategory of the Western Ontario and McMaster Universities Osteoarthritis Index. Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult). The pain score can be a minimum of 0 and a maximum of 20. A higher pain score indicates more pain. Visual Analog Scale consists of a horizontal 10 cm straight line. When viewed from left to right, there is a value of 0 at the beginning and 10 at the end of the line. The 0 point of the line indicates no pain and the 10 point indicates the most severe pain felt in life.
Knee range of motion
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Knee range of motion was assessed using the Copenhagen Knee Range of Motion Scale. In this scale, knee range of motion is assessed based on illustrations. For the knee joint flexion angle, 6 different illustrations are used: 60°, 75°, 90°, 105°, 120° and 135°. For the knee extension angle, 5 different illustrations are used: 45°, 30°, 15°, 0° and -15°.
Health-related quality of life
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Health-related quality of life was assessed with the Short Form-12. In the Short Form-12, the physical component summary-12 score is obtained from the physical functioning, physical role, body pain and general health sub-dimensions, while the mental component summary-12 score is obtained from the vitality, social functioning, emotional role and mental health sub-dimensions. Both physical component summary-12 and mental component summary-12 scores range between 0-100, with higher scores indicating better health status.
General quality of life
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
General quality of life was assessed with the World Health Organization Quality of Life Brief Version. World Health Organization Quality of Life Brief Version consists of 4 domains: physical health, psychological, social relationships and environment. In World Health Organization Quality of Life Brief Version, each domain is scored separately and expressed as a percentage between 0 and 100, with a higher percentage indicating better health.
Lower extremity muscle strength
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Lower extremity muscle strength was assessed with the 30-seconds chair-stand test. The number of times the patient stands up completely from the chair within 30 seconds is recorded as the patient's score.
Locomotor performance
Time frame: The assessments were performed before surgery and at the first, second and third months after surgery.
Locomotor performance was assessed with the stair climb test. The time taken to ascend and then descend a 9-step staircase was recorded as the patient's score.
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 6 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.
Akın Süzer, PT, PhD principal investigator
Burdur Mehmet Akif Ersoy University
Nihal Büker, PT, PhD study director
Pamukkale University
Harun R Güngör, MD, PhD principal investigator
Pamukkale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard exercises and core stability exercises in people with Knee Arthropathy and Telerehabilitation, run by Burdur Mehmet Akif Ersoy University at 2 sites 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 5 inclusion and 9 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 6 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 2 sites 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?
Functional level (time frame: The assessments were performed before surgery and at the first, second and third months after surgery.). The study lists 7 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 6 Dec 2023.