Hip OsteoarthritisNCT05272748
The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation in Patients With Hip and/or Knee Osteoarthritis
A study testing Conventional Exercise + Core Stabilization Exercise and Conventional Exercise in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Saglik Bilimleri Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
Age-related hip and knee osteoarthritis is the leading cause of pain and locomotor problems worldwide. There is no definitive solution in the treatment of hip and knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Conventional Exercise + Core Stabilization Exercise and Conventional Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 16 Mar 2022to 11 Jun 2024
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman
- 40 years or older
- Diagnosed with primary hip and/or knee osteoarthritis as a result of radiological and clinical examination
- Informed written consent
Who cannot join
- Using an assistive device
- Prior orthopedic surgery of the knee and hip
- Intra-articular injection of the knee in the last 3 months
- Clinical or radiological meniscus, cartilage and/or ligament problem
- Severe physical trauma in the past 3 months
- Severe psychological trauma in the past 3 months
Show all 11Show fewer
- Arterial and venous circulation disorder
- Presence of skin lesions on and around the knee joint
- Presence of neuromuscular disease and/or neurological deficit
- Presence of vertigo, diabetes mellitus, hearing and vision problems
- Not having the technologies to access telerehabilitation services
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sağlık Bilimleri University
Istanbul
Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma Hastanesi
Istanbul
About this study
Official title: The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation on Pain, Postural Control, Functional Level and Fear of Fall in Patients With Hip and/or Knee Osteoarthritis
Age-related hip and knee osteoarthritis is the leading cause of pain and locomotor problems worldwide. There is no definitive solution in the treatment of hip and knee osteoarthritis. In the guidelines of the American Rheumatology Association, pharmacological and non-pharmacological treatment methods are recommended for the treatment of hip and knee osteoarthritis. The effectiveness of different exercise programs for the periarticular muscles in hip and knee osteoarthritis has been proven, but there is no consensus on the superiority of exercise protocols over each other. With the increase in home isolation of individuals due to the COVID-19 pandemic, telerehabilitation applications have gained popularity.In the literature, there is a need for studies investigating the effectiveness of core stabilization exercises in patients with hip and knee osteoarthritis. Therefore, our study will help develop alternative exercises for individuals with hip and knee osteoarthritis. In the literature, there is no study investigating the effectiveness of core stabilization exercises applied with the telerehabilitation method in patients with knee osteoarthritis and comparing them with conventional exercise. According to the data to be obtained as a result of the study, the use of core stabilization exercises in the treatment of hip and knee osteoarthritis will contribute to the literature as an alternative exercise method. The application of these exercises with the telerehabilitation method in the treatment of hip and knee osteoarthritis will highlight new studies in the literature as a unique methodology. Thus, it will contribute to the development of cost-effective rehabilitation methods in the treatment of hip and knee osteoarthritis.
The hypotheses of this study are as follows:
Read more
H0:There is no difference between the effects of combined exercise with telerehabilitation (conventional exercise + core stabilization exercise) and the effects of conventional exercise in the treatment of hip and/or knee osteoarthritis.
H1:Combined exercise with telerehabilitation application (conventional exercise + core stabilization exercise) is more effective than conventional exercise in the treatment of hip and/or knee osteoarthritis.
Main Purpose: To compare the effects of conventional exercise and core stabilization exercises by telerehabilitation on pain, postural control, functional level, and fear of falling in patients with hip and/or knee osteoarthritis.
Secondary Purposes:
- To evaluate the effects of core stabilization exercises on pain, postural control, functional level, fear of falling in female patients with hip and/or knee osteoarthritis.
- To evaluate the effectiveness of telerehabilitation exercise in female patients with hip and/or knee osteoarthritis.
- To determine the possible limitations that may be encountered in the application of exercise by telerehabilitation in female patients with hip and/or knee osteoarthritis and to provide appropriate conditions for the patients.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Conventional Exercise + Core Stabilization Exercise, Conventional Exercise
- Keywords
- hip osteoarthritis, knee osteoarthritis, telerehabilitation, core stabilization
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Exercise + Core Stabilization ExerciseOther
Before and after the treatment, patients' pain, postural control (static and dynamic balance), functional level and fear of falling will be evaluated. In addition to the exercises in the conventional exercise group, patients will perform pelvic tilt, lateral bridge, single leg bridge, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, superman exercise. Exercises will be applied 3 times a week.
Conventional ExerciseOther
Before and after the treatment, patients' pain, postural control (static and dynamic balance), functional level and fear of falling will be evaluated. Terminal knee extension, straight leg raise, heel slide, adductor isometric, bridge, mini squat, heel raise, lunge, range of motion and stretching exercises for lower extremities will be performed by the patients. Exercises will be applied 3 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Exercise + Core Stabilization Exercise | Experimental | Conventional exercises and core stabilization exercises will be performed with the telerehabilitation method for 8 weeks. Patients will be contacted via laptop, ipad and phones with cameras, microphones and internet connection. Exercise by telerehabilitation will be implemented with a live connection for the first 4 weeks. In the second 4 week periods, exercise videos will be given to the patients and it will be checked by phone. In addition to the exercises in the conventional exercise group, patients will perform pelvic tilt, lateral bridge, single leg bridge, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, superman exercise. Exercises will be applied 3 times a week. Receives: Other: Conventional Exercise + Core Stabilization Exercise |
| Conventional Exercise | Experimental | Conventional exercises used in the treatment of knee and hip osteoarthritis will be performed by the telerehabilitation method for 8 weeks. Patients will be contacted via laptop, ipad and phones with cameras, microphones and internet connection. Exercise by telerehabilitation will be implemented with a live connection for the first 4 weeks. In the second 4 week periods, exercise videos will be given to the patients and it will be checked by phone. Terminal knee extension, straight leg raise, heel slide, adductor isometric, bridge, mini squat, heel raise, lunge, range of motion and stretching exercises for lower extremities will be performed by the patients. Exercises will be applied 3 times a week. Receives: Other: Conventional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is used for the evaluation of pain intensity. This 11-point scale is used to measure the severity of pain between 0 and 10 points. In the scale, there are numbers between 0 and 10 arranged horizontally, with 0: "No pain", 10: "Unbearable pain".
Measured: Change from Baseline NRS Score at 8 weeks
Berg Balance Scale (BBS)
Berg Balance Scale (BBS) examines both static and dynamic balance functions. BBS consists of 14 items and evaluates the ability of individuals to maintain their balance during activities. Each section is scored between 0 and 4 as 0: "Activity Not Completed", 4: "Activity Independent" completed.
Measured: Change from Baseline BBS Score at 8 weeks
Timed Up and Go Test (TUG)
Timed Up and Go Test (TUG) is used for the evaluation of functional level. After the patient rested for 15 seconds in a back-supported chair, the test is started with the command "start". The patient is asked to get up from the chair without support from the hands and walk the marked 3-meter track, as quickly as possible, but without running, at his own pace, and sit back on the chair, and the elapsed time is recorded in seconds. A trial was made for the patient to learn the test, and then the test was repeated 3 times and the average time was recorded.
Measured: Change from Baseline TUG Score at 8 weeks
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) is used for the evaluation of functional level in patients with knee osteoarthritis. Each question is answered using a score of 0-4 (0: "None" - 4: "Extreme") with five answer options.
Measured: Change from Baseline KOOS-PS Score at 8 weeks
Hip Disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)
Hip Disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS) is used for the evaluation of functional level in patients with hip osteoarthritis. Each question is answered using a score of 0-4 (0: "None" - 4: "Extreme") with five answer options.
Measured: Change from Baseline HOOS-PS Score at 8 weeks
The Falls Efficacy Scale International (FES-I)
The Falls Efficacy Scale International (FES-I) is used for the evaluation of fear of fall. Each question is answered using a range of 1-4 points (1: "Not at all concerned" - 4: "Very concerned") with four answer options.
Measured: Change from Baseline FES-I Score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start16 Mar 2022
- Primary completion1 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zuhal Didem Takinacı, Asst. Prof., Principal investigator, Saglik Bilimleri Universitesiİlknur Aktaş, MD., Prof., Principal investigator, Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272748
- Sponsor's protocol ID
- 21-90
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2022
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation on Pain, Postural Control, Functional Level and Fear of Fall in Patients With Hip and/or Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05272748
- Acronym / sponsor ID
- 21-90
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- hip osteoarthritis, knee osteoarthritis, telerehabilitation, core stabilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 9 Mar 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.
Age-related hip and knee osteoarthritis is the leading cause of pain and locomotor problems worldwide. There is no definitive solution in the treatment of hip and knee osteoarthritis. In the guidelines of the American Rheumatology Association, pharmacological and non-pharmacological treatment methods are recommended for the treatment of hip and knee osteoarthritis. The effectiveness of different exercise programs for the periarticular muscles in hip and knee osteoarthritis has been proven, but there is no consensus on the superiority of exercise protocols over each other. With the increase in home isolation of individuals due to the COVID-19 pandemic, telerehabilitation applications have gained popularity.In the literature, there is a need for studies investigating the effectiveness of core stabilization exercises in patients with hip and knee osteoarthritis. Therefore, our study will help develop alternative exercises for individuals with hip and knee osteoarthritis. In the literature, there is no study investigating the effectiveness of core stabilization exercises applied with the telerehabilitation method in patients with knee osteoarthritis and comparing them with conventional exercise. According to the data to be obtained as a result of the study, the use of core stabilization exercises in the treatment of hip and knee osteoarthritis will contribute to the literature as an alternative exercise method. The application of these exercises with the telerehabilitation method in the treatment of hip and knee osteoarthritis will highlight new studies in the literature as a unique methodology. Thus, it will contribute to the development of cost-effective rehabilitation methods in the treatment of hip and knee osteoarthritis.
The hypotheses of this study are as follows:
H0:There is no difference between the effects of combined exercise with telerehabilitation (conventional exercise + core stabilization exercise) and the effects of conventional exercise in the treatment of hip and/or knee osteoarthritis.
H1:Combined exercise with telerehabilitation application (conventional exercise + core stabilization exercise) is more effective than conventional exercise in the treatment of hip and/or knee osteoarthritis.
Main Purpose: To compare the effects of conventional exercise and core stabilization exercises by telerehabilitation on pain, postural control, functional level, and fear of falling in patients with hip and/or knee osteoarthritis.
Secondary Purposes:
- To evaluate the effects of core stabilization exercises on pain, postural control, functional level, fear of falling in female patients with hip and/or knee osteoarthritis.
- To evaluate the effectiveness of telerehabilitation exercise in female patients with hip and/or knee osteoarthritis.
- To determine the possible limitations that may be encountered in the application of exercise by telerehabilitation in female patients with hip and/or knee osteoarthritis and to provide appropriate conditions for the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Exercise + Core Stabilization Exercise | Experimental | Other: Conventional Exercise + Core Stabilization ExerciseConventional exercises and core stabilization exercises will be performed with the telerehabilitation method for 8 weeks. Patients will be contacted via laptop, ipad and phones with cameras, microphones and internet connection. Exercise by telerehabilitation will be implemented with a live connection for the first 4 weeks. In the second 4 week periods, exercise videos will be given to the patients and it will be checked by phone. In addition to the exercises in the conventional exercise group, patients will perform pelvic tilt, lateral bridge, single leg bridge, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, superman exercise. Exercises will be applied 3 times a week. |
| Conventional Exercise | Experimental | Other: Conventional ExerciseConventional exercises used in the treatment of knee and hip osteoarthritis will be performed by the telerehabilitation method for 8 weeks. Patients will be contacted via laptop, ipad and phones with cameras, microphones and internet connection. Exercise by telerehabilitation will be implemented with a live connection for the first 4 weeks. In the second 4 week periods, exercise videos will be given to the patients and it will be checked by phone. Terminal knee extension, straight leg raise, heel slide, adductor isometric, bridge, mini squat, heel raise, lunge, range of motion and stretching exercises for lower extremities will be performed by the patients. Exercises will be applied 3 times a week. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman
- 40 years or older
- Diagnosed with primary hip and/or knee osteoarthritis as a result of radiological and clinical examination
- Informed written consent
Key exclusion criteria (11 listed)
- Using an assistive device
- Prior orthopedic surgery of the knee and hip
- Intra-articular injection of the knee in the last 3 months
- Clinical or radiological meniscus, cartilage and/or ligament problem
- Severe physical trauma in the past 3 months
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 |
|---|---|---|
| Conventional Exercise + Core Stabilization ExerciseBefore and after the treatment, patients' pain, postural control (static and dynamic balance), functional level and fear of falling will be evaluated. In addition to the exercises in the conventional exercise group, patients will perform pelvic tilt, lateral bridge, single leg bridge, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, superman exercise. Exercises will be applied 3 times a week. | Other | Conventional Exercise + Core Stabilization Exercise |
| Conventional ExerciseBefore and after the treatment, patients' pain, postural control (static and dynamic balance), functional level and fear of falling will be evaluated. Terminal knee extension, straight leg raise, heel slide, adductor isometric, bridge, mini squat, heel raise, lunge, range of motion and stretching exercises for lower extremities will be performed by the patients. Exercises will be applied 3 times a week. | Other | Conventional Exercise |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Change from Baseline NRS Score at 8 weeks
Numerical Rating Scale (NRS) is used for the evaluation of pain intensity. This 11-point scale is used to measure the severity of pain between 0 and 10 points. In the scale, there are numbers between 0 and 10 arranged horizontally, with 0: "No pain", 10: "Unbearable pain".
Berg Balance Scale (BBS)
Time frame: Change from Baseline BBS Score at 8 weeks
Berg Balance Scale (BBS) examines both static and dynamic balance functions. BBS consists of 14 items and evaluates the ability of individuals to maintain their balance during activities. Each section is scored between 0 and 4 as 0: "Activity Not Completed", 4: "Activity Independent" completed.
Timed Up and Go Test (TUG)
Time frame: Change from Baseline TUG Score at 8 weeks
Timed Up and Go Test (TUG) is used for the evaluation of functional level. After the patient rested for 15 seconds in a back-supported chair, the test is started with the command "start". The patient is asked to get up from the chair without support from the hands and walk the marked 3-meter track, as quickly as possible, but without running, at his own pace, and sit back on the chair, and the elapsed time is recorded in seconds. A trial was made for the patient to learn the test, and then the test was repeated 3 times and the average time was recorded.
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)
Time frame: Change from Baseline KOOS-PS Score at 8 weeks
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) is used for the evaluation of functional level in patients with knee osteoarthritis. Each question is answered using a score of 0-4 (0: "None" - 4: "Extreme") with five answer options.
Hip Disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)
Time frame: Change from Baseline HOOS-PS Score at 8 weeks
Hip Disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS) is used for the evaluation of functional level in patients with hip osteoarthritis. Each question is answered using a score of 0-4 (0: "None" - 4: "Extreme") with five answer options.
The Falls Efficacy Scale International (FES-I)
Time frame: Change from Baseline FES-I Score at 8 weeks
The Falls Efficacy Scale International (FES-I) is used for the evaluation of fear of fall. Each question is answered using a range of 1-4 points (1: "Not at all concerned" - 4: "Very concerned") with four answer options.
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 1 Jul 2024.
- 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.
Zuhal Didem Takinacı, Asst. Prof. principal investigator
Saglik Bilimleri Universitesi
İlknur Aktaş, MD., Prof. principal investigator
Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma Hastanesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Exercise + Core Stabilization Exercise and Conventional Exercise in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Saglik Bilimleri Universitesi 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 4 inclusion and 11 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 1 Jul 2024. 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?
Numerical Rating Scale (NRS) (time frame: Change from Baseline NRS Score at 8 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 1 Jul 2024.