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NCT Number: NCT03484910

Biofeedback With Cycling Exercise in OA Knee Patients

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.

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Key information

Conditions

Exercise Therapy Arthritis Biofeedback Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis of Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, 40402, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise therapy

Other

Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback

Primary outcomes

  1. Change of quadriceps strength

    Time frame: Baseline and after six-week training

    Change from Baseline quadriceps strength after six-week training

  2. Change of Functional questionnaire

    Time frame: Baseline and after six-week training

    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.

  3. Change of Pain

    Time frame: Baseline and after six-week training

    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.

Secondary outcomes

  1. Changes of thigh muscle activation

    Time frame: Baseline, after 3-week and six-week training

    Change from Baseline electromyography of vasti at 3-week and 6-week

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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