- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06650865
Effect of Baduanjin on Individuals With Knee Osteoarthritis
Effect of Baduanjin on Pain, Balance and Kinesiophobia in Individuals With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is a long-term chronic disease in which stiffness, pain and impaired mobility occur when bones rub against each other as a result of deterioration of the cartilage in the joints. Although the disease most commonly affects the joints in the knees, hands, feet and spine, it can also be observed in the shoulder and hip joints. Clinical symptoms of OA, which is a common joint disease, include pain, joint stiffness, weakened proprioception, impaired balance and dysfunction that severely affect quality of life.
The main aim of osteoarthritis rehabilitation is to prevent functional losses by reducing pain and increasing muscle strength. Conservative treatment, pharmacologic treatment and surgical treatment are applied in osteoarthritis rehabilitation. Exercise practices, which are recommended with a high level of evidence, are the most important building blocks of conservative treatment. In individuals with knee OA, strengthening exercises, which are the leading exercise interventions, increase strength as well as power and endurance. As a result of increased muscle strength, stress on the joint is reduced, resulting in increased correct loading and stabilization. Skeletal muscles contract isometrically, concentrically and eccentrically to support the body weight against gravity and absorb shock. Eccentric strength is an integral part of lower extremity-specific activities of daily living.
When the literature is reviewed, recent studies have shown that OA patients have positive perspectives on traditional aerobic exercise. Tai Chi has been proven to reduce pain and improve physical function. Qigong, which emerged before Tai Chi, is accepted as another traditional aerobic exercise preferred by patients with knee osteoarthritis who cannot tolerate intense physical activities. An important complementary part of qigong, the Baduanjin exercise (Eight-Part Exercises or Eight-Part Brocades) consists of eight separate postures (supporting the chest, drawing arcs to both sides, raising one hand, practicing looking back, waving the hand and wagging the tail, touching the feet with both hands, climbing with both hands and relaxing the back). Baduanjin is a set of exercises, a qigong (chi kung) practice originating in China. The term "Ba Duan Jin" means "eight pieces of brocade" or "eight silk threads" in Chinese. This series of exercises involves a series of movements involving body posture, breath control and mental concentration. The main purpose of Baduanjin is to increase the circulation of energy (chi or qi), promote balance in the body, increase flexibility and improve overall health. According to traditional Chinese medicine, the free circulation of chi and its balanced distribution throughout the body is the key to a healthy life. This exercise series aims to create a physical, mental and energetic balance.
Each can have beneficial effects on different parts of the body or on specific organs. Similar to Tai Chi, Baduanjin exercise is recognized as a multicomponent therapy that combines physical, psychosocial, cognitive and spiritual components. Compared to Tai Chi, Baduanjin exercise has fewer physical and cognitive requirements, which makes it very suitable for application in patients with knee osteoarthritis in a short time. In this study, it is aimed to determine the effect of Baduanjin to reduce kinesiobia and increase functional exercise capacity by reducing or completely eliminating balance loss and pain in patients with knee osteoarthritis and to shed light on future studies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Biruni University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with osteoarthritis of the knee,
- 40-70 years old,
- BMI <40 kg/m2,
- Grade II and Grade III OA according to the Kellgren and Lawrence radiographic classification,
- Score of 24 and above on the Standardized Mini Mental State Examination
Exclusion Criteria:
- Underwent surgery involving the lower limbs and spine,
- History of ligament injury or joint luxation involving the lower extremity,
- Diagnosed with a neurological disease affecting the lower extremities,
- Diagnosed with cardiovascular disease,
- Not receiving any other treatment in the last 3 months
- Taking anxiolytic and sedative drugs,
- Psychiatric illness,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Traditional Exercise Group
The routine exercise program applied to individuals with osteoarthritis who applied to the orthopedic clinic where the data will be obtained is given below. 1st week exercises
Exercises added in week 2
Exercises added in week 4
Exercises added in week 6
The exercise program will be taught to the patient and given as a home program. |
It is important for the therapist to organize a exercise program to provide pain control. The exercise program should be specific and clear to the patient. Exercises will be applied to this group. The exercise steps will be continued 3 days a week for 6 weeks. All scales and tests will be completed again at week 12 for long-term follow-up.
Other Names:
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Experimental: Baduanjin Exercise Group
Standard Physical Therapy Program + Baduanjin exercises Baduanjin exercises An important complementary part of Qigong, the Baduanjin exercise (Eight Part Exercises or Eight Part Brocades) consists of eight different postures (supporting the chest, drawing arcs to both sides, raising one hand, practicing looking back, waving the hand and wagging the tail, touching the feet with both hands, climbing with both hands and relaxing the back). The exercise program will be taught to the patient and given as a home program. |
In addition to the standard physical therapy program, Baduanjin will be applied for 30 minutes. The exercise steps will be continued 3 days a week for 6 weeks. All scales and tests will be completed again at week 12 for long-term follow-up.
Other Names:
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Experimental: Telerehabilitation group
Baduanjin exercise will be applied simultaneously with the telerehabilitation method. Standard Physical Therapy Program + Baduanjin exercises Baduanjin exercises An important complementary part of Qigong, the Baduanjin exercise (Eight Part Exercises or Eight Part Brocades) consists of eight different postures (supporting the chest, drawing arcs to both sides, raising one hand, practicing looking back, waving the hand and wagging the tail, touching the feet with both hands, climbing with both hands and relaxing the back). The exercise program will be taught to the patient and given as a home program. |
Baduanjin exercise will be applied simultaneously with the telerehabilitation method. In addition to the standard physical therapy program, Baduanjin will be applied for 30 minutes. The exercise steps will be continued 3 days a week for 6 weeks. All scales and tests will be completed again at week 12 for long-term follow-up.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline in pain on the Visual Analog Scale (VAS) at week 12. Change from baseline in balance on the Berg Balance Scale (BDS) at week 12.
Time Frame: 12 weeks
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The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity.
The VAS is a 0-10 cm (0-100 mm) long measuring instrument.
The scale starts with "no pain" and ends with "unbearable pain".
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12 weeks
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Change from baseline on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12
Time Frame: 12 weeks
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WOMAC assesses patients' pain, stiffness and physical function in the last 48 hours.
A higher score indicates an increase in pain, stiffness and lack of physical function.
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12 weeks
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Change from baseline in pain on the Berg Balance Scale at week 12
Time Frame: 12 weeks
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The Berg Balance Scale (BBS) is a scale that includes 14 instructions and for each instruction, the patient's performance is observed and a score between 0 and 4 is given.
A score of 0 is given when the patient cannot perform the activity at all, while a score of 4 is given when the patient completes the activity independently.
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12 weeks
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Change from baseline in pain on the Timed Up & Go (TUG) Test at week 12
Time Frame: 12 weeks
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The Timed Up and Go (TUG) test is a test used to determine dynamic balance and fall risk.
The time it takes for a person to get up from a chair, walk three meters, turn 180 degrees, walk back to the chair and sit down while turning 180 degrees is calculated.
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12 weeks
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Change from baseline in pain on the 30-second Sit-Rise Test at week 12
Time Frame: 12 weeks
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30-second Sit-Rise test is a test used to measure leg strength and endurance for 30 s.
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12 weeks
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Change from baseline in pain on the Tampa Scale of Kinesiophobia (TSK) at week 12
Time Frame: 12 weeks
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The Tampa Kinesiophobia scale is a scale to measure patients' avoidance of exercise and fear of movement.
A high score on the scale indicates a high level of kinesiophobia.
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12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1.
- Kennedy DM, Stratford PW, Wessel J, Gollish JD, Penney D. Assessing stability and change of four performance measures: a longitudinal study evaluating outcome following total hip and knee arthroplasty. BMC Musculoskelet Disord. 2005 Jan 28;6:3. doi: 10.1186/1471-2474-6-3.
- Levinger P, Dunn J, Bifera N, Butson M, Elias G, Hill KD. High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 18;18(1):384. doi: 10.1186/s13063-017-2129-7.
- Lockhart C, Scott BR, Thoseby B, Dascombe BJ. Acute Effects of Interset Rest Duration on Physiological and Perceptual Responses to Resistance Exercise in Hypoxia. J Strength Cond Res. 2020 Aug;34(8):2241-2249. doi: 10.1519/JSC.0000000000002755.
- Ghandali E, Moghadam ST, Hadian MR, Olyaei G, Jalaie S, Sajjadi E. The effect of Tai Chi exercises on postural stability and control in older patients with knee osteoarthritis. J Bodyw Mov Ther. 2017 Jul;21(3):594-598. doi: 10.1016/j.jbmt.2016.09.001. Epub 2016 Sep 10.
- Xiong X, Wang P, Li S, Zhang Y, Li X. Effect of Baduanjin exercise for hypertension: a systematic review and meta-analysis of randomized controlled trials. Maturitas. 2015 Apr;80(4):370-8. doi: 10.1016/j.maturitas.2015.01.002. Epub 2015 Jan 9.
- Dore AL, Golightly YM, Mercer VS, Shi XA, Renner JB, Jordan JM, Nelson AE. Lower-extremity osteoarthritis and the risk of falls in a community-based longitudinal study of adults with and without osteoarthritis. Arthritis Care Res (Hoboken). 2015 May;67(5):633-9. doi: 10.1002/acr.22499.
- Li D, Li S, Chen Q, Xie X. The Prevalence of Symptomatic Knee Osteoarthritis in Relation to Age, Sex, Area, Region, and Body Mass Index in China: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2020 Jul 16;7:304. doi: 10.3389/fmed.2020.00304. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Osteoarthritis
- Osteoarthritis, Knee
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- 145361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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