Comparing Exercise Programs for Managing Knee Osteoarthritis

NCT06711341 | Completed

• 1 other identifier: 2023-15/19
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess and compare the effectiveness of three different exercise modalities-whole-body vibration exercise, progressive resistance exercise, and home-based exercise -in improving quadriceps isometric muscle strength, physical function, balance, knee pain, osteoarthritis symptoms, and overall quality of life in individuals with knee osteoarthritis. The main questions it aims to answer are:

• How do WBV, PRE, and home-based exercise compare in improving quadriceps strength in people with knee osteoarthritis?
• Which exercise modality leads to the greatest improvements in physical function, balance, knee pain, and quality of life? Researchers will compare the three exercise regimens to determine which is most effective for improving knee function and relieving osteoarthritis symptoms. Participants will:
• Engage in whole-body vibration exercise, progressive resistance exercise, or home-based exercise for 3 weeks.
• Undergo assessments before and at the end of the exercise program, including tests for physical function and balance (Timed Up and Go Test, 5x Sit to Stand Test) and questionnaires to evaluate knee osteoarthritis symptoms (WOMAC), quality of life (SF-36), and self-reported knee pain (Numeric Rating Scale).

Conditions

Knee OA; Osteoarthritis; Osteoarthritis (OA) of the Knee

Keywords

Exercise; Knee Osteoarthritis; Pain; Strength; Whole-Body Vibration

Outcome Measures

Primary Outcomes (1)

• Quadriceps Isometric Muscle Strength

  Quadriceps isometric muscle strength is measured using an Isokinetic dynamometer (CSMI Humac Norm, Stoughton, MA). Measurements are taken in a sitting position with the knee positioned at two angles: 30° and 60° of flexion. For each angle, one trial is performed followed by three real measurements, with the highest peak torque recorded in Newton-meters (Nm). Participants are secured to the dynamometer, and all settings and positions are standardized. Prior to measurements, the device is calibrated, and participants perform a 5-minute warm-up and familiarize themselves with the test procedure. Verbal encouragement is provided during the tests.

  at baseline and 3-weeks

Secondary Outcomes (5)

• Timed Up and Go (TUG) Test (Physical Function and Balance)

  at baseline and 3-weeks

• Five Times Sit to Stand Test (5xSST) (Physical Function and Balance)

  at baseline and 3-weeks

• Numeric Rating Scale (NRS) (Self-reported Knee Pain)

  at baseline and 3-weeks

• WOMAC (Knee Osteoarthritis Symptoms and Function)

  at baseline and 3-weeks

• SF-36 (Quality of Life)

  at baseline and 3-weeks

Study Arms (3)

Whole-body Vibration (WBV) Training Group

ACTIVE COMPARATOR

Participants undergo WBV training as outlined in the WBV intervention, 3 days per week for 3 weeks. The sessions begin with a duration of 10 minutes in the first week, with the duration increasing each week thereafter. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions.

Device: Whole-body Vibration (WBV) Training

Progressive Resistance Exercise (PRE) Group

ACTIVE COMPARATOR

Participants undergo PRE training as outlined in the PRE intervention, 3 days per week for 3 weeks. The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle at the start of each week. They also perform the home exercises assigned to the Control group on the same days as their PRE sessions.

Behavioral: Progressive Resistance Exercise (PRE)

Control Group (Home-Based Exercise)

ACTIVE COMPARATOR

Participants perform home exercises three days per week for 3 weeks. The exercises consist of range of motion (ROM) and isometric strengthening exercises as detailed in the intervention section.

Behavioral: Home-Based Exercise

Interventions

Whole-body Vibration (WBV) Training DEVICE

Participants use the "Compex Winplate," designed specifically for vibration training. The device is set with a frequency of 30 Hz and an amplitude of 4 mm. Participants perform a total of 5 exercises consisting of static and dynamic squat exercises, with a 30-second rest period between sets and between different exercises. The exercises and progression over the weeks are as follows: Week 1: * Static squat with knees flexed at 30° - 2 sets of 30 seconds each * Dynamic squat with knees flexed between 0-60° - 2 sets of 30 seconds each * Fingertip-to-sole partial dynamic squat with knees flexed at 30° - 2 sets of 30 seconds each * Consecutive weight transfer with knees flexed at 45° - 2 sets of 30 seconds each * Single leg static squat with knees flexed at 30° - 30 seconds per leg Subsequent Weeks: The duration of each set increases by 10 seconds each week. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises.

Also known as: WBV

Whole-body Vibration (WBV) Training Group

Progressive Resistance Exercise (PRE) BEHAVIORAL

Training Duration: Participants undergo approximately 15-20 minute training sessions, 3 days per week for 3 weeks. Exercise Regimen: The training focuses on strengthening the quadriceps muscles using ankle weights. The load is determined using the DeLorme principle: * At the beginning of each week, the 10-repetition maximum (10RM) is measured. * During that week, participants perform their training sets as follows: * First set: 50% of 10RM * Second set: 75% of 10RM * Final set: 100% of 10RM Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises.

Also known as: PRE

Progressive Resistance Exercise (PRE) Group

Home-Based Exercise BEHAVIORAL

Protocol: Participants receive a printed document with instructions for home exercises and are instructed on how to perform the exercises. Training Duration: Sessions are conducted three days per week for 3 weeks. Exercise Regimen: The exercises include: * Bilateral Quadriceps Isometric Exercise: Participants lie on their backs with a roll below each knee, pressing for 10-second holds, totaling 20 repetitions. * Knee Extensions: Participants performed knee extensions while seated, holding each extension for 5 seconds, completing 10 repetitions per leg. * Knee Range of Motion (ROM) Exercises: Participants lie face down and alternately bend their knees, completing 10 repetitions. Each training session includes a 5-minute warm-up and a 5-minute cooldown, consisting of joint motion and muscle stretching exercises

Control Group (Home-Based Exercise)

Eligibility Criteria

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

You may qualify if:

• participants between the ages of 45-70,
• diagnosed with knee osteoarthritis according to ACR criteria (unilateral or bilateral),
• having grade 2 or 3 tibiofemoral knee osteoarthritis according to Kellgren-Lawrence staging,
• having knee pain due to OA for a minimum of 3 months prior to enrollment,
• patients whose medical treatment is not expected to change during the study period.

You may not qualify if:

• having or had undergone knee surgery,
• patients unable to walk without support,
• having musculoskeletal limitations that prevent participation in resistance exercises (contracture, fracture, etc.),
• other neurological, cardiac, respiratory and systemic diseases that will affect physical activity,
• currently implementing a regular exercise or physical therapy program specific to knee OA

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludağ University Hospital Physical Medicine and Rehabilitation Clinic

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Motor Activity; Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is a single-blinded randomized controlled trial. Participants are not blinded to their group assignment. However, the researcher responsible for conducting tests and data collection is blinded to the group assignments to avoid any assessment bias. The researcher who handles randomization and group allocation is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: August 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)