Clinical trial NCT06331858: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis
Official title: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise to Instrumented Knee Flexor-Extensor Concentric Strengthening Exercise on Pain, Function, Physical Performance, and Quality of Life in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Pain
Physical Disability
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. STUDY GROUP
2. CONTROL GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA).

Detailed description: This prospective randomized single-blind controlled study was conducted at Kütahya Health Sciences University (KHSU) Evliya Çelebi Education and Research Hospital (ECERH) Physical Medicine and Rehabilitation (PMR) annex building between September 2023 and March 2024. The study protocol was approved by the ethics committee of the same university (2023-03/03).

Eligibility criteria: Inclusion Criteria:

* Receiving a diagnosis of knee osteoarthritis according to the ACR criteria and being classified as stage 2-3 according to the Kellgren Lawrence staging
* Having symptomatic unilateral or bilateral knee pain with a VAS (0-10) pain score \> 4
* Being able to ambulate independently without orthosis/prosthesis
* Having a body mass index less than 35

Exclusion Criteria:

* History of knee and hip surgery
* Presence of lesions, atrophy, or scars in the skin area
* Intra-articular injection to the knee within the last 6 months
* Receiving active physiotherapy, physical therapy, or spa treatment in the last 6 months
* Patients with chronic diseases such as COPD, coronary artery disease
* Those with oxygen saturation levels \<95%
* Individuals with any pathological condition that may impair normal walking
* Patients with diseases such as vertigo, epilepsy that may pose a risk during physical performance tests
* Patients with contraindications to strength training exercises

Primary outcomes:
measure: Western Ontario and McMaster Universities (WOMAC)
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: The Lequesne Algofunctional index
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: TIME UP AND GO TEST
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: 30 SECOND CHAIR TEST
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: 40 METER SELF PACED WALK TEST
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: SIX MINUTES WALK TEST
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: STAIR CLIMB TEST
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
measure: Mini Osteoarthritis Knee and Hip Quality of Life Scale
timeFrame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Hasan H Gökpınar
role: STUDY_DIRECTOR
References: