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Osteoarthritis, KneeNCT06650865

Effect of Baduanjin on Individuals With Knee Osteoarthritis

A study testing Traditional Exercise Group, Baduanjin Exercise Group and Telerehabilitation Group in people with Osteoarthritis, Knee, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis (OA) is the most common rheumatologic disease in the world, primarily resulting in progressive cartilage destruction. It is most common in the knee joint. In this study, it is aimed to determine the effect of Baduanjin to reduce kinesiobia and increase functional exercise capacity by reducing or… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Traditional Exercise Group, Baduanjin Exercise Group and Telerehabilitation Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2024to 15 Feb 2025
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Biruni University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Baduanjin on Pain, Balance and Kinesiophobia in Individuals With Knee Osteoarthritis

Osteoarthritis (OA) is the most common rheumatologic disease in the world, primarily resulting in progressive cartilage destruction. It is most common in the knee joint. 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. 60 individuals between 40 and 70 years of age with osteoarthritis will be included in the study. Individuals will be randomized into three groups. In the study, Visual Analog Scale (VAS) was used to assess the severity of pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to assess physical activity level, Berg Balance Scale (BDS) was used to assess balance, Tampa Kinesiophobia Scale (TKS) was used to assess kinesiophobia, Timed Up and Go Test (TUGT) and 30 Second Sit and Stand Test were used to assess functional levels. In our study, an exercise program accompanied by a physiotherapist will be applied for 12 weeks, 3 days a week. Exercise program will be applied to the first group and Baduanjin exercises will be applied to the second group in addition to the exercise program. Baduanjin exercise will be applied to the third group synchronously with the telerehabilitation method. It is thought that both techniques applied in our study may have positive effects on pain, kinesiophobia and physical function.

Read the 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.

Being tested
Traditional Exercise Group, Baduanjin Exercise Group, Telerehabilitation Group
Keywords
Osteoarthritis, pain
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Exercise GroupOther

    Also called exercise

    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.

  • Baduanjin Exercise GroupOther

    Also called exercise

    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.

  • Telerehabilitation GroupOther

    Also called exercise

    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.

Study groups in NCT06650865
Study groupRoleWhat they receive
Traditional Exercise GroupActive comparatorThe 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 * Isometric quadriceps set * Terminal knee extension * Knee extension at 90 degrees flexion * Isometric gluteus maximus exercises Exercises added in week 2 * Four-way straight leg raises * Bridge exercise * Fingertip elevation Exercises added in week 4 * Mini squat (0-30 degrees) * Getting up from a chair without support * Leg press exercise with Theraband Exercises added in week 6 * Stepping up and down * Exercises for rising on one leg * Semi squat (0-60 degrees) The exercise program will be taught to the patient and given as a home program.
Receives: Other: Traditional Exercise Group
Baduanjin Exercise GroupExperimentalStandard 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.
Receives: Other: Baduanjin Exercise Group
Telerehabilitation groupExperimentalBaduanjin 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.
Receives: Other: Telerehabilitation Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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".

    Measured: 12 weeks

  2. Change from baseline on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12

    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.

    Measured: 12 weeks

  3. Change from baseline in pain on the Berg Balance Scale at week 12

    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.

    Measured: 12 weeks

  4. Change from baseline in pain on the Timed Up & Go (TUG) Test at week 12

    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.

    Measured: 12 weeks

  5. Change from baseline in pain on the 30-second Sit-Rise Test at week 12

    30-second Sit-Rise test is a test used to measure leg strength and endurance for 30 s.

    Measured: 12 weeks

  6. Change from baseline in pain on the Tampa Scale of Kinesiophobia (TSK) at week 12

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion15 Jan 2025
  4. Study completion15 Feb 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06650865
Sponsor's protocol ID
145361
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15679884
  • 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.

    PubMed 30063554
  • 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.

    PubMed 28183213
  • 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.

    PubMed 25331686
  • 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.

    PubMed 28750970
  • 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.

    PubMed 28821271
  • 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.

    PubMed 32766258
  • 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.

    PubMed 25636242

Questions about this trial

What is this clinical trial studying?

A study testing Traditional Exercise Group, Baduanjin Exercise Group and Telerehabilitation Group in people with Osteoarthritis, Knee, run by Biruni University at 1 site in Turkey (Türkiye).

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 5 inclusion and 7 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 19 Sep 2025. 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 Turkey (Türkiye). 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 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). The study lists 6 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 NCT06650865, which also lists 8 linked publications.

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 19 Sep 2025.

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