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The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation in Patients With Hip and/or Knee Osteoarthritis

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Exercise
Conventional Exercise + Core Stabilization Exercise
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip osteoarthritis, knee osteoarthritis, telerehabilitation, core stabilization

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman
  • 40 years or older
  • Diagnosed with primary hip and/or knee osteoarthritis as a result of radiological and clinical examination
  • Informed written consent

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Sağlık Bilimleri UniversityRecruiting
  • Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional Exercise

Conventional Exercise + Core Stabilization Exercise

Arm Description

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. Strengthening and flexibility exercises will be done to the conventional exercise group. Hip and knee isometric and isotonic exercises, terminal knee extension, mini squat, lunge, range of motion exercises for lower extremities, hamstring, quadriceps, gastrocnemius stretching exercises will be performed by the patients. Exercises will be applied 3 times a week.

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 bridging, lateral bridging, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, clam exercise. Exercises will be applied 3 times a week.

Outcomes

Primary Outcome Measures

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".
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2022
Last Updated
April 11, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05272748
Brief Title
The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation in Patients With Hip and/or Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis
Keywords
hip osteoarthritis, knee osteoarthritis, telerehabilitation, core stabilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Exercise
Arm Type
Experimental
Arm Description
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. Strengthening and flexibility exercises will be done to the conventional exercise group. Hip and knee isometric and isotonic exercises, terminal knee extension, mini squat, lunge, range of motion exercises for lower extremities, hamstring, quadriceps, gastrocnemius stretching exercises will be performed by the patients. Exercises will be applied 3 times a week.
Arm Title
Conventional Exercise + Core Stabilization Exercise
Arm Type
Experimental
Arm Description
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 bridging, lateral bridging, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, clam exercise. Exercises will be applied 3 times a week.
Intervention Type
Other
Intervention Name(s)
Conventional Exercise
Intervention Description
Before and after the treatment, patients' pain, postural control (static and dynamic balance), functional level and fear of falling will be evaluated. Strengthening and flexibility exercises will be done to the conventional exercise group. Hip and knee isometric and isotonic exercises, terminal knee extension, mini squat, lunge, range of motion exercises for lower extremities, hamstring, quadriceps, gastrocnemius stretching exercises will be performed by the patients. Exercises will be applied 3 times a week.
Intervention Type
Other
Intervention Name(s)
Conventional Exercise + Core Stabilization Exercise
Intervention Description
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 bridging, lateral bridging, plank, extremity exercises in the crawling position, abdominal crunch, oblique crunch, dead bug, clam exercise. Exercises will be applied 3 times a week.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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".
Time Frame
Change from Baseline NRS Score at 8 weeks
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Change from Baseline BBS Score at 8 weeks
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
Change from Baseline TUG Score at 8 weeks
Title
Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS)
Description
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.
Time Frame
Change from Baseline KOOS-PS Score at 8 weeks
Title
Hip Disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)
Description
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.
Time Frame
Change from Baseline HOOS-PS Score at 8 weeks
Title
The Falls Efficacy Scale International (FES-I)
Description
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.
Time Frame
Change from Baseline FES-I Score at 8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only Female Participants
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman 40 years or older Diagnosed with primary hip and/or knee osteoarthritis as a result of radiological and clinical examination Informed written consent Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuhal Didem Takinacı, Asst. Prof.
Phone
00000000000
Email
didemtakinaci@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laçin Naz Taşcılar, PT., MSc.
Phone
00000000000
Email
lacintascilar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuhal Didem Takinacı, Asst. Prof.
Organizational Affiliation
Sağlık Bilimleri University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İlknur Aktaş, MD., Prof.
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sağlık Bilimleri University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuhal Didem Takinacı, Asst. Prof.
Email
didemtakinaci@gmail.com
Facility Name
Sağlık Bilimleri Üniversitesi Fatih Sultan Mehmet Eğitim Ve Araştırma Hastanesi
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İlknur Aktaş, MD., Prof.
Email
iaktas@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Conventional Exercise Combined With Core Stabilization Exercise by Telerehabilitation in Patients With Hip and/or Knee Osteoarthritis

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