Clinical trial NCT06159205: Core Stability Via Telerehabitation on TKA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Telerehabilitation
Keywords: total knee arthroplasty
exercise
core stability
telerehabilitation
physiotherapy
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
First posted: 2023-12-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a double-blind, randomised controlled trial.
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Functional level
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: Pain intensity
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: Knee range of motion
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: Health-related quality of life
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: General quality of life
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: Lower extremity muscle strength
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
measure: Locomotor performance
timeFrame: The assessments were performed before surgery and at the first, second and third months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Akın Süzer, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Nihal Büker, PT, PhD
role: STUDY_DIRECTOR
affiliation: Pamukkale University
name: Harun R Güngör, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Nusret Ök, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Raziye Şavkın, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: