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

NCT06331858 | Completed

• 1 other identifier: KutahyaHSU-DRGOKPINARDROMER-43
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis; Pain; Physical Disability

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (2)

• Visual Analog Scale (VAS)

  TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)

• Mini Osteoarthritis Knee and Hip Quality of Life Scale

  TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)

Study Arms (2)

Study group

ACTIVE COMPARATOR

The study group received hip device-assisted concentric abductor strengthening (HDACAS) program in addition to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program.

Device: hip device-assisted concentric abductor strengthening (HDACAS); Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES)

Control group

ACTIVE COMPARATOR

The control group received only KDACFES program

Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES)

Interventions

hip device-assisted concentric abductor strengthening (HDACAS) DEVICE

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

Study group

knee device-assisted concentric flexor-extensor strengthening (KDACFES) DEVICE

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

Control group; Study group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasan H Gökpınar

  Kutahya Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Before and after the treatment, all patients were evaluated by a blind evaluator in terms of physical examination, pain and functionality, physical performance, quality of life and gait parameters.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 1. STUDY GROUP 2. CONTROL GROUP

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 26, 2024
• Study Start: September 20, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

TU (1)