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Biofeedback With Cycling Exercise in OA Knee Patients

Primary Purpose

Exercise Therapy, Osteoarthritis Of Knee, Biofeedback

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise therapy
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Exercise Therapy

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BFB group

CON group

Arm Description

Exercise therapy - Six-week training program of stationary cycling with a real-time visual EMG biofeedback

Exercise therapy - Six-week training program of stationary cycling without EMG biofeedback

Outcomes

Primary Outcome Measures

Change of quadriceps strength
Change from Baseline quadriceps strength 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.
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.

Secondary Outcome Measures

Changes of thigh muscle activation
Change from Baseline electromyography of vasti at 3-week and 6-week

Full Information

First Posted
March 19, 2018
Last Updated
November 7, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03484910
Brief Title
Biofeedback With Cycling Exercise in OA Knee Patients
Official Title
Application of Biofeedback Combined With Cycling Exercise in the Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
January 18, 2020 (Actual)
Study Completion Date
January 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy, Osteoarthritis Of Knee, Biofeedback

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFB group
Arm Type
Experimental
Arm Description
Exercise therapy - Six-week training program of stationary cycling with a real-time visual EMG biofeedback
Arm Title
CON group
Arm Type
Active Comparator
Arm Description
Exercise therapy - Six-week training program of stationary cycling without EMG biofeedback
Intervention Type
Other
Intervention Name(s)
Exercise therapy
Intervention Description
Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback
Primary Outcome Measure Information:
Title
Change of quadriceps strength
Description
Change from Baseline quadriceps strength after six-week training
Time Frame
Baseline and after six-week training
Title
Change of Functional questionnaire
Description
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.
Time Frame
Baseline and after six-week training
Title
Change of Pain
Description
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.
Time Frame
Baseline and after six-week training
Secondary Outcome Measure Information:
Title
Changes of thigh muscle activation
Description
Change from Baseline electromyography of vasti at 3-week and 6-week
Time Frame
Baseline, after 3-week and six-week training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
China Medical University
City
Taichung City
ZIP/Postal Code
40402
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Biofeedback With Cycling Exercise in OA Knee Patients

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