The Effect of Baduanjin on Patients Undergoing Knee Replacement Surgery

NCT07109557 | Recruiting

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

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• The Effect of Baduanjin on Pain

  Visual Analogue Scale:The Visual Analog Scale is a one-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm).Since the aim of the study is to determine the effect of the non-pharmacological method used on existing pain, VAS will be used in the pain assessment before and after the application. (Postoperative Day 1): Baseline assessment with VAS, (Postoperative Week 4): Follow-up assessment with VAS (Postoperative Week 8): Final assessment with VAS

  12 month

• The Effect of Baduanjin on Quality of Recovery

  Quality of Recovery-40 (QoR-40): The QoR-40 scale evaluates post-surgical recovery and includes five sub-dimensions: emotional state, physical comfort, patient support, physical independence, and pain. It consists of 40 items, each rated on a 5-point Likert scale (1-5). Subscale scores are calculated by summing relevant items; total scores range from 40 to 200. Higher scores reflect better physical and emotional recovery, while lower scores indicate impaired well-being. The QoR-40 will be administered after transfer to the clinic, before the Su Jok therapy, to assess recovery quality in the first 24 hours post-surgery. Reassessments will be conducted at three time points: (1) Postoperative Day 1 (baseline), (2) Postoperative Week 4 (follow-up), and (3) Postoperative Week 8 (final). This structured approach will provide insight into the patient's recovery progress over time.

  12 month

• The Effect of Baduanjin on Comfort

  General Comfort Scale: Developed by Kolcaba, the General Comfort Scale assesses individuals' comfort needs and the effectiveness of nursing interventions. It is structured on a taxonomy with three levels and four dimensions, reflecting the theoretical components of comfort. The scale includes 48 items rated on a four-point Likert scale. Items are a mix of positive and negative statements. In positive items, a score of 4 indicates high comfort, while 1 indicates low comfort. Negative items are reverse-scored before summing. The total score ranges from 48 to 192, with higher scores indicating greater overall comfort. In this study, the scale will be administered at three time points: (1) Postoperative Day 1 (baseline), (2) Postoperative Week 4 (follow-up), and (3) Postoperative Week 8 (final) to evaluate the progression of comfort throughout the recovery process.

  12 month

Study Arms (2)

Baduanjin

EXPERIMENTAL

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

Other: Baduanjin

Standard care

NO INTERVENTION

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

Interventions

Baduanjin OTHER

Baduanjin exercise

Baduanjin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with contraindications to Baduanjin exercises,
• Over 70 years old,
• Using anxiolytic and sedative drugs,

Sponsors & Collaborators

• Niran Çoban: lead

Study Sites (1)

Niran Çoban

Yalova, 77000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  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

• 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.

  PMID: 22588748 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• NİRAN ÇOBAN

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

  STUDY DIRECTOR

Central Study Contacts

NİRAN ÇOBAN

CONTACT

05301586912; nirancoban@gmail.com

Seçkin Özcan

CONTACT

05418078632; seckin.ozcan@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst.Prof.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)