Baduanjin With Resistance Training Program

NCT06853132 | Recruiting DMC

• 1 other identifier: 2000039398
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.

Conditions

Osteoporosis; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (3)

• Change in Quality of life measured by the Oswestry Disability Index (ODI)

  ODI is the most widely accepted scales for assessing quality of life and the severity of disability caused by back pain. It assesses the impact of back pain on various daily activities. The ODI is a questionnaire containing 10 items covering disability caused by low back pain. Each item is assessed on a six-level ordinal scale with "0" describing "no limitation" and "5" describing "extreme limitation or an inability to function", with higher values representing a greater extent of disability. The total score is converted to a percentage to determine the severity of disability. Scores are interpreted as follows: 0-20% (minimal disability), 21-40% (moderate disability), 41-60% (severe disability), 61-80% (crippled), and 81-100% (bed-bound or exaggerating symptoms). The Cronbach's alpha of this scale was 0.89.

  Weeks 0, 1, 12, and 24

• Change in Muscle strength by the Five Times Sit-to-Stand Test (FTSS)

  The researchers need to record the total time spent going from sit to stand. At last, the test will be performed three times, and the final average in seconds is taken. Each patient was given 2 minutes intervals for rest. The time it takes to complete the five times sit-to-stand test (FTSST) varies by age and gender. Healthy adults complete the test in ≤ 10 seconds; times ≥15 seconds indicate increased fall risk and mobility impairments. The Cronbach alpha 0.99, and the reliability was 0.97.

  Weeks 0, 1, 12, and 24

• Change in physical activity level by the International Physical Activity Questionnaire (IPAQ).

  The IPAQ-LC is a widely used tool for assessing physical activity levels in various populations. This scale requires participants to complete 31 questions across four activity domains (transportation, work, household, and leisure time), and includes sections on walking, moderate and vigorous activity, and sedentary behaviors (sitting and lying awake\]. The exercises recorded must last at least 10 minutes each time. To calculate a total activity score, the reported activity is assigned a Metabolic Equivalents (MET) value based on its intensity. (1) Low Activity Level: \<600 MET minutes/ a week; (2) Moderate Activity Level: 600\~3000 MET minutes/ a week; (3) \> 3000 MET minutes/ a week. The Cronbach's alpha of this scale was 0.88.

  Weeks 0, 1, 12, and 24

Secondary Outcomes (3)

• Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE)

  Weeks 0, 1, 12, and 24

• Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS)

  Weeks 0, 1, 12, and 24

• Incidence of complications after surgery

  Week 1

Study Arms (2)

Control Group

NO INTERVENTION

Participants will receive conventional (usual) treatment: continue with their original treatment, medication, and diet habits. After spinal surgery, two nurses trained according to this study protocol will teach participants standard guidance for lumbar and back exercises, which will include exercise suggestions and health education.

BDJ with resistance training

EXPERIMENTAL

BDJ exercise combined with resistance training and conventional (usual) treatment in the experimental group. Two nurses will provide training to ensure that participants can perform the movements skillfully and coherently.

Behavioral: Baduanjin with Resistance Training Program

Interventions

Baduanjin with Resistance Training Program BEHAVIORAL

Baduanjin with Resistance Training Program

BDJ with resistance training

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with LDH and OP based on the chart and clinical diagnostic criteria.
• Age of female patients ≥ 45 years，age of male patients ≥ 50 years.
• Visual analogue scale (VAS) ≥ 3 points.
• Surgical operation will be performed during the 7-day admission period.
• Mandarin speakers.

You may not qualify if:

• Severe primary diseases: ulcerative colitis, gastrointestinal bleeding, pancreatitis, lung cancer, pneumonia, acute respiratory distress syndrome or psychosis, depression, anxiety or substance abuse, identified by diagnosis and interview.
• Current engagement in regular physical activity routines over the past 3 months: aerobic exercises for at least 30 minutes, at least 3 times per week.
• Taken drugs within 3 months before enrollment: bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin, etc.

Sponsors & Collaborators

• Yale University: lead
• Yale-China Association: collaborator

Study Sites (1)

Second Xiangya Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

3. Soohyun Nam, PhD

CONTACT

510-290-2387; soohyun.nam@yale.edu

Tieying Qiu, RN

CONTACT

qiuty@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with LDH and OP who will be treated and undergo surgery will be recruited as potential participants from two spinal wards at the Second Xiangya Hospital of Central South University (Class A hospital) in Changsha City, Hunan Province.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)