The Effect of Baduanjin on Patients Undergoing Knee Replacement Surgery

NCT ID: NCT07109557

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

Brief Summary

This randomized controlled trial aims to evaluate the effects of Baduanjin, a traditional Chinese mind-body exercise, on pain, comfort, and quality of recovery in patients undergoing total knee arthroplasty (TKA). The study will be conducted between July 2025 and July 2026 at Yalova Training and Research Hospital's Orthopedics Clinic. Sixty patients will be randomly assigned into two groups: an intervention group practicing Baduanjin and a control group receiving standard postoperative care. The intervention will begin on the first postoperative day and continue for three weeks. Outcome measures include the Visual Analog Scale (VAS) for pain, the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40) questionnaire. These assessments will be conducted weekly for three weeks. The control group will follow routine postoperative care without Baduanjin. The primary objective is to determine whether Baduanjin can improve postoperative outcomes in terms of pain reduction, increased comfort, and better recovery quality.

Detailed Description

Total knee arthroplasty (TKA) is one of the most frequently performed orthopedic surgeries, especially among elderly individuals, to relieve pain, improve joint function, and enhance quality of life in patients with advanced knee osteoarthritis. However, the postoperative period can be challenging due to significant pain, reduced comfort, limited mobility, and psychological distress, all of which may negatively affect the recovery process. Effective postoperative management is essential to reduce pain, improve comfort, and enhance the quality of recovery.

Pharmacological treatments are commonly used for postoperative pain management; however, their side effects and limitations have increased interest in complementary and integrative practices. One such practice is Baduanjin, a traditional Chinese mind-body exercise that consists of eight gentle, coordinated movements. These movements integrate physical posture, breathing control, and mental focus to promote physical and emotional well-being. Baduanjin can be practiced while standing or sitting, making it suitable for patients in the postoperative period. Studies suggest that Baduanjin may reduce pain, improve psychological states such as anxiety and depression, and promote faster physical recovery through improved circulation, joint flexibility, and relaxation.

This randomized controlled trial aims to evaluate the effects of Baduanjin exercises on pain intensity, comfort level, and quality of recovery in patients who have undergone total knee arthroplasty. The study will be conducted between July 2025 and July 2026 at Yalova Training and Research Hospital, Orthopedics Clinic. A total of 60 participants will be randomly assigned into two groups using a random number table: a Baduanjin group (intervention) and a control group. The intervention group will perform supervised Baduanjin exercises starting from the first postoperative day for a duration of three weeks. Exercises will be practiced under nurse supervision and consist of the eight classical Baduanjin movements.

Pain, comfort, and quality of recovery will be evaluated at the end of each week using the Visual Analog Scale (VAS), the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40) instrument. The control group will receive only routine postoperative care, including standard physical therapy and pain management, and will complete the same assessments at the same time intervals.

The primary hypothesis is that Baduanjin practice will significantly reduce pain, increase comfort levels, and improve the quality of recovery in patients undergoing TKA compared to standard care. The secondary objective is to contribute to the growing body of evidence supporting non-pharmacological, mind-body interventions in postoperative nursing care. Given its accessibility, safety, and ease of learning, Baduanjin may serve as a valuable complementary method to enhance surgical recovery and patient well-being

Conditions

Pain, Postoperative; Surgery; Knee Replacement; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Baduanjin

Participants in this arm will receive supervised Baduanjin exercises in addition to routine postoperative care. The Baduanjin protocol will begin on Postoperative Day 1 and continue for 3 weeks, with daily practice under guidance. Data collection will be performed at four time points using the Visual Analog Scale (VAS), the General Comfort Questionnaire, and the Quality of Recovery-40 (QoR-40).

Interview and Application Schedule:

Interview I (Preoperative): Face-to-face interview one day before surgery; informed consent and sociodemographic data collection

Interview II (Postoperative Day 1): Start of Baduanjin; baseline assessment with VAS, QoR-40, and Comfort Questionnaire

Interview III (Postoperative Week 4): Follow-up assessment with VAS, QoR-40, and Comfort Questionnaire

Interview IV (Postoperative Week 8): Final assessment with VAS, QoR-40, and Comfort Questionnaire

Group Type: EXPERIMENTAL

Baduanjin

Intervention Type: OTHER

Baduanjin exercise

Standard care

Description:

Participants in this arm will receive standard postoperative nursing care and physical therapy, without any complementary intervention. Data will be collected at the same four time points as in the intervention group for comparison purposes.

Interview and Application Schedule:

Interview I (Preoperative): Face-to-face interview one day before surgery; informed consent and sociodemographic data collection

Interview II (Postoperative Day 1): Baseline assessment with VAS, QoR-40, and Comfort Questionnaire

Interview III (Postoperative Week 4): Follow-up assessment with VAS, QoR-40, and Comfort Questionnaire

Interview IV (Postoperative Week 8): Final assessment with VAS, QoR-40, and Comfort Questionnaire

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Baduanjin

Baduanjin exercise

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having undergone Knee Replacement Surgery under general anesthesia

• 18 years old and over,
• Are in stable condition after surgery,
• Are conscious, and
• Volunteer to participate in the study.

Exclusion Criteria

• Patients with contraindications to Baduanjin exercises,

-• Over 70 years old,

• Using anxiolytic and sedative drugs,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Niran Çoban

OTHER

Sponsor Role: lead

Responsible Party

Niran Çoban

Asst.Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

NİRAN ÇOBAN

Role: STUDY_DIRECTOR

https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

Locations

Niran Çoban

Yalova, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

NİRAN ÇOBAN

Role: CONTACT

nirancoban@gmail.com

05301586912

Seçkin Özcan

Role: CONTACT

seckin.ozcan@yalova.edu.tr

05418078632

Facility Contacts

Seçkin Özcan

Role: primary

seckin.ozcan@yalova.edu.tr

05418078632

References

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Reference Type: BACKGROUND

PMID: 28750970 (View on PubMed)

Tao T, Shi MP, Tan BY, Zhang XS, Sun FL, Liu BR, Li SJ, Li ZH. Evaluation of traditional Chinese exercise for knee osteoarthritis (KOA): an overview of systematic reviews. Syst Rev. 2024 Jul 18;13(1):187. doi: 10.1186/s13643-024-02606-0.

Reference Type: BACKGROUND

PMID: 39026375 (View on PubMed)

Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

Reference Type: BACKGROUND

PMID: 10740540 (View on PubMed)

Karaman S, Arici S, Dogru S, Karaman T, Tapar H, Kaya Z, Suren M, Gurler Balta M. Validation of the Turkish version of the Quality of Recovery-40 questionnaire. Health Qual Life Outcomes. 2014 Jan 15;12:8. doi: 10.1186/1477-7525-12-8.

Reference Type: BACKGROUND

PMID: 24428925 (View on PubMed)

Wang, X., Pi, Y., Chen, B., et al. (2020). Effectiveness of Baduanjin exercise for limb function, activities of daily living, and quality of life in post-stroke patients: A systematic review and meta-analysis. Frontiers in Aging Neuroscience, 12, 123

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 25636242 (View on PubMed)

Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

Reference Type: BACKGROUND

PMID: 22588748 (View on PubMed)

Other Identifiers

NCBN

Identifier Type: -

Identifier Source: org_study_id