Biofeedback With Cycling Exercise in OA Knee Patients

Application of Biofeedback Combined With Cycling Exercise in the Patients With Osteoarthritis of the Knee

Osteoarthritis (OA) is one of the most common joint diseases causing pain, muscle weakness and disability in older population. Quadriceps muscle weakness is one of the recognized risk factors for the development and the progression of the disease. Increasing the muscle strength could actually bring many benefits to the knee OA patients. The purposes of this study are 1) to investigate the effects of combining the EMG biofeedback technique into a stationary cycling exercise on the activities of vastus medialis (VM) in people with medial compartment knee OA; 2) To investigate the efficiency of a 6-week cycling exercise program on improving of quadriceps muscle strength and endurance, physical functions and pain in these patients and compare between the conditions of with or without EMG biofeedback; 3) To determine the relationships between the muscle activities and the kinematics of the knee joint during this cycling exercise program; and therefore to find the mechanism of the improvement on muscle activities in the intervention of cycling combining EMG biofeedback. In this study, we will enroll the knee OA patients from our hospital, and they will be randomly assigned either to the control group, who will cycle without biofeedback, or the biofeedback group, who will cycle with a real-time visual EMG biofeedback, during the six-week training program. The exercise program consisted of a 5-minute warm-up with low-resistance cycling, 30-minute moderate-resistance cycling exercise, and 5-minute cool down session. . The knee adduction angle, quadriceps strength and endurance, KOOS Chinese version, VAS scale will also be measured at baseline and after six weeks of intervention. Mixed-model repeated measure analysis of variance (ANOVA) will be used to determine if there are any differences in the kinematic, myoelectric, muscle strength and endurance. It is hoped that the results of this study could provide information regarding the proper and efficient training strategy for the OA knee patients, and deliver the concepts of proper exercise technique to enhance health in the community.

Study Overview

• Status: Completed
• Conditions: Exercise Therapy; Biofeedback; Osteoarthritis Of Knee
• Intervention / Treatment: Other: Exercise therapy

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung City, Taiwan, 40402
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• the OA knee patients are those who had medial compartment tibiofemoral osteoarthritis in either one or both of their knees, had at least a grade 2 on the Kellgren-Lawrence score, which was verified with radiographs and a diagnosis by a physician

Exclusion Criteria:

• if the participant had been diagnosed with OA in the hip or ankle joints, had a lower extremity joint replacement, had knee joint arthroscopic surgery or intra-articular injections within 3 months prior to testing, had systemic inflammatory arthritis such as rheumatoid or psoriatic arthritis, had lower back pain that referred to the lower limbs, or those who had cardiovascular disease or other risk factor which precluded participation in aerobic exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFB group; Exercise therapy - Six-week training program of stationary cycling with a real-time visual EMG biofeedback	Other: Exercise therapy; Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback
Active Comparator: CON group; Exercise therapy - Six-week training program of stationary cycling without EMG biofeedback	Other: Exercise therapy; Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of quadriceps strength	Change from Baseline quadriceps strength after six-week training	Baseline and after six-week training
Change of Functional questionnaire	Change from Baseline KOOS Chinese version after six-week training. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is patient-administered that commonly used to evaluate the extent of knee pain and functional impairments in patients with different knee conditions, including knee OA. There are five subscales in this questionnaire.The score range is 0-100 and calculated for each subscale with lower score indicating extreme problems.	Baseline and after six-week training
Change of Pain	Change from Baseline VAS scale after six-week training. A standard 10-centimeter visual analog scale (VAS) is a unidimensional measure of pain intensity. The score range is 0-10 with a higher score indicating greater pain intensity.	Baseline and after six-week training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of thigh muscle activation	Change from Baseline electromyography of vasti at 3-week and 6-week	Baseline, after 3-week and six-week training

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): January 18, 2020
• Study Completion (Actual): January 18, 2020

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CMUH106-REC3-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No