Exercise TherapyNCT03484910
Biofeedback With Cycling Exercise in OA Knee Patients
A study testing Exercise therapy in people with Exercise Therapy and Osteoarthritis Of Knee, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Exercise Therapy, Osteoarthritis Of Knee, Biofeedback
- What is being tested?
- Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2018to 18 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Exercise Therapy, Osteoarthritis Of Knee, Biofeedback
- Being tested
- Exercise therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback
| Study group | Role | What they receive |
|---|---|---|
| BFB group | Experimental | Exercise therapy - Six-week training program of stationary cycling with a real-time visual EMG biofeedback Receives: Other: Exercise therapy |
| CON group | Active comparator | Exercise therapy - Six-week training program of stationary cycling without EMG biofeedback Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of quadriceps strength
Change from Baseline quadriceps strength after six-week training
Measured: 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.
Measured: 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.
Measured: Baseline and after six-week training
Secondary outcomes (1)
Changes of thigh muscle activation
Change from Baseline electromyography of vasti at 3-week and 6-week
Measured: Baseline, after 3-week and six-week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start2 Mar 2018
- Primary completion18 Jan 2020
- Study completion18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiu-Chen Lin, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484910
- Sponsor's protocol ID
- CMUH106-REC3-001
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2018
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang CM, Chung H, Hsu HC, Chen LT, Lin RY, Lin HC. Effectiveness of stationary cycling with electromyographic biofeedback on neuromuscular control and function in individuals with knee osteoarthritis: a feasibility study. BMC Musculoskelet Disord. 2025 Jun 3;26(1):547. doi: 10.1186/s12891-025-08794-7.
PubMed 40462058
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Biofeedback Combined With Cycling Exercise in the Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03484910
- Acronym / sponsor ID
- CMUH106-REC3-001
- Conditions
- Exercise Therapy, Osteoarthritis Of Knee, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 18 Jan 2020 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFB group | Experimental | Other: Exercise therapyExercise therapy - Six-week training program of stationary cycling with a real-time visual EMG biofeedback |
| CON group | Active comparator | Other: Exercise therapyExercise therapy - Six-week training program of stationary cycling without EMG biofeedback |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapySix-week training program of stationary cycling with / without a real-time visual EMG biofeedback | Other | BFB group, CON group |
Primary outcome
Change of quadriceps strength
Time frame: Baseline and after six-week training
Change from Baseline quadriceps strength after six-week training
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.
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.
1 secondary outcome
Changes of thigh muscle activation
Time frame: Baseline, after 3-week and six-week training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 40462058Chang CM, Chung H, Hsu HC, Chen LT, Lin RY, Lin HC. Effectiveness of stationary cycling with electromyographic biofeedback on neuromuscular control and function in individuals with knee osteoarthritis: a feasibility study. BMC Musculoskelet Disord. 2025 Jun 3;26(1):547. doi: 10.1186/s12891-025-08794-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy in people with Exercise Therapy and Osteoarthritis Of Knee, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of quadriceps strength (time frame: Baseline and after six-week training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.