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Recruiting NCT07109557

The Effect of Baduanjin on Patients Undergoing Knee Replacement Surgery

No phase Interventional Pain, Postoperative Surgery Knee Replacement Nurse's Role

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baduanjin.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Surgery, Knee Replacement, Nurse's Role. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Baduanjin on Pain, Comfort, and Quality of Recovery in Patients Undergoing Knee Replacement Surgery

Overview

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

Interventions

  • Other Baduanjin
    Baduanjin exercise

Primary outcome measures

  • The Effect of Baduanjin on Pain [Time frame: 12 month]
  • The Effect of Baduanjin on Quality of Recovery [Time frame: 12 month]
  • The Effect of Baduanjin on Comfort [Time frame: 12 month]

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,
  • Patients with any mental illness and those who do not meet the inclusion criteria will not be included in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Niran Çoban — Yalova

Publications

  • 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
  • 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. PMID 39026375
  • 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. PMID 10740540
  • 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. PMID 24428925
  • 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
  • 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
  • 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 (Ho PMID 22588748

Identifiers

NCT: NCT07109557 · NCBN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗