The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331858
• Other study ID #: KutahyaHSU-DRGOKPINARDROMER-43
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: March 2024
• Source: Kutahya Health Sciences University
• Contact: Hasan H Gökpinar
• Phone: 00905052842222
• Email: hasanhuseyin.gokpinar[@]ksbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain
• Physical Disability

Intervention

Device:
• hip device-assisted concentric abductor strengthening (HDACAS)
All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions
• knee device-assisted concentric flexor-extensor strengthening (KDACFES)
All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities (WOMAC)	Assessments consist of three components: pain, stiffness, and functionality. The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	The Lequesne Algofunctional index	It is a disease-specific measure used to assess the pain, maximum walking distance, and daily life activities of knee osteoarthritis patients.; The Lequesne Algofunctional index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living. The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability.	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	TIME UP AND GO TEST	With this test, patients' ability to maintain balance during transfer and walking is assessed. One source suggests that scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	30 SECOND CHAIR TEST	This test requires the individual to sit and stand continuously for 30 seconds with arms crossed over the chest and is based on the maximum number of repetitions the individual can perform. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions.Great: 19 or more reps in 30 seconds means your endurance and lower-body strength are above average. You have the greatest life expectancy. Average: Between 10 and 18 reps indicates average endurance and lower-body strength. Poor: 9 reps or fewer should be considered a warning sign.	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	40 METER SELF PACED WALK TEST	It is a test focused on measuring mobility and function. It is based on walking a certain distance in the fastest possible time, competing against time. A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) (2). As a direct measure of the ability to walk quickly over short distances, which is an activity that is important but often limited in people with hip and/or knee OA. Regular walking aid is allowed and recorded. Time of one trial, with turn time excluded, is recorded and expressed as speed m/s by dividing distance (40 m) by time (s)	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	SIX MINUTES WALK TEST	The 6-minute walk test, which is a reliable and valid mobility test for measuring walking activity, is the most commonly used test in clinical trials. The maximum distance that can be walked over a 6-min interval is recorded. Rest periods are allowed but included in the time Standardized encouragement (e.g., keep going you are doing really well") can be given at minute intervals. Regular walking aid is allowed. Practice test not needed in most clinical settings but if performed then at least 1 h rest should be allowed before the second test. The greatest distance is then recorded	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Primary	STAIR CLIMB TEST	It is a test that varies in the number of steps, but the most commonly used and the version found on the OARSI website is the 9-step stair climb test. Ascend and descend flight of nine stairs in a usual manner, and at a safe and comfortable pace. Use of any walking aid and handrail is permitted and recorded. Total time to ascend and descend steps for one trial is recorded in seconds	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Secondary	Visual Analog Scale (VAS)	The intensity of pain ranges from '0' to '10', with '0' indicating no pain and '10' representing the worst pain the person has ever experienced in their life	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Secondary	Mini Osteoarthritis Knee and Hip Quality of Life Scale	It is derived from the original Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire, developed to assess Health-Related Quality of Life (HRQoL) in patients with knee and/or hip osteoarthritis. It includes five subscales: physical activities, mental health, pain, social support, social functioning; with three additional independent items addressing sexual life, professional life, and fear of being dependent. The numerical rating scales in the items range from 0 (worst) to 10 (best). Scores were obtained by computing the means of the item scores in each subscale. The last three items' score (independent items) becomes the corresponding score.	TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)