Effect of Baduanjin on Individuals With Knee Osteoarthritis

NCT06650865 | Completed

• 1 other identifier: 145361
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, pain

Outcome Measures

Primary Outcomes (6)

• 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".

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

• 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.

  12 weeks

Study Arms (3)

Traditional Exercise Group

ACTIVE COMPARATOR

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 * 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.

Other: Traditional Exercise Group

Baduanjin Exercise Group

EXPERIMENTAL

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.

Other: Baduanjin Exercise Group

Telerehabilitation group

EXPERIMENTAL

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.

Other: Telerehabilitation Group

Interventions

Traditional Exercise Group OTHER

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.

Also known as: exercise

Traditional Exercise Group

Baduanjin Exercise Group OTHER

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.

Also known as: exercise

Baduanjin Exercise Group

Telerehabilitation Group OTHER

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.

Also known as: exercise

Telerehabilitation group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with osteoarthritis of the knee,
• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 28183213 BACKGROUND

• 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.

  PMID: 25331686 BACKGROUND

• 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.

  PMID: 28750970 BACKGROUND

• 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.

  PMID: 15679884 BACKGROUND

• 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.

  PMID: 28821271 BACKGROUND

• 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.

  PMID: 32766258 BACKGROUND

• 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.

  PMID: 30063554 BACKGROUND

• 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.

  PMID: 25636242 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof. Dr, PhD

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: October 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: February 15, 2025
• Last Updated: September 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)