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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272748
• Other study ID #: 21-90
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: November 15, 2022

Study information

• Verified date: February 2022
• Source: Saglik Bilimleri Universitesi
• Contact: Zuhal Didem Takinaci, Asst. Prof.
• Phone: 00000000000
• Email: didemtakinaci[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: November 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Other:
• Conventional Exercise
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.
• Conventional Exercise + Core Stabilization Exercise
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Fatih Sultan Mehmet Egitim Ve Arastirma Hastanesi	Istanbul
Turkey	Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Change from Baseline NRS Score at 8 weeks
Primary	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.	Change from Baseline BBS Score at 8 weeks
Primary	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.	Change from Baseline TUG Score at 8 weeks
Primary	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.	Change from Baseline KOOS-PS Score at 8 weeks
Primary	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.	Change from Baseline HOOS-PS Score at 8 weeks
Primary	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.	Change from Baseline FES-I Score at 8 weeks