OsteoporosisNCT06853132
Baduanjin With Resistance Training Program
A study testing Baduanjin with Resistance Training Program in people with Osteoporosis and Lumbar Disc Herniation, run by Yale University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis, Lumbar Disc Herniation
- What is being tested?
- Baduanjin with Resistance Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baduanjin With Resistance Training Program for Elderly Patients With Osteoporosis and Lumbar Disc Herniation
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.
Read the detailed description
Participants in the control group will continue with their conventional post surgery treatment as follows: comprehensive post-operative care and educational handouts that include guidelines for lumbar and back exercises to improve recovery and promote spinal health. In addition, participants will receive three interactive Q\&A sessions before discharge (pre-operation, post-operation, and on the day of discharge). During these sessions, patients can discuss their concerns and ask questions about their recovery.
Participants in the experimental group will continue to receive their conventional post surgery treatment in addition to BDJ as follows: Individual session training (admission to week 1 post-surgery), no training week 2, Group session I (week 3 and 4), Group session 2 (week 5-12) and perform independent exercises during which participants will have to keep an exercise diary (week 13-24).
Data collection will be conducted through in-person visits at baseline and Week 1, followed by phone calls at Week 12 and Week 24.
- Conditions
- Osteoporosis, Lumbar Disc Herniation
- Being tested
- Baduanjin with Resistance Training Program
- Medical subject headings
- Osteoporosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin with Resistance Training ProgramBehavioural
Baduanjin with Resistance Training Program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Baduanjin with Resistance Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weeks 0, 1, 12, and 24
Secondary outcomes (3)
Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE)
This scale is designed to test individual's confidence to exercise in the face of barriers to exercise. It consists of 9 items, with scores ranging from 0 to 10 representing the exercise confidence levels. A score of 0 indicates "no confidence", while a score of 10 indicates "very confident". Total score range is 0-90. Higher scores reflect a greater level of exercise self-efficacy. The Cronbach alpha for this scale is 0.93.
Measured: Weeks 0, 1, 12, and 24
Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS)
This scale assesses the perceived benefits and barriers to exercise among patients. The EBBS consists of 43 items that evaluate the perceived benefits of exercise and factors that hinder participation. It includes two dimensions: exercise benefits and exercise barriers. A 4-point Likert scale is used (1 = "strongly disagree", 4 = "strongly agree"). The total score ranges from 43 to 172, with higher scores indicating more positive perceptions of exercise benefits and fewer perceived barriers. The Cronbach alphas for the overall scale and the two subscales are 0.86, 0.95, and 0.86, respectively.
Measured: Weeks 0, 1, 12, and 24
Incidence of complications after surgery
Complications will be recorded by registered nurses. The data will be collected by clinical chart reviews and patient interviews. The incidence of complication after surgery will be calculated by the number of new complications / total number of participants in each group.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start30 Aug 2025
- Primary completion5 Jun 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale-China Association
- Responsible party
- Sponsor
- Investigators
- Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853132
- Sponsor's protocol ID
- 2000039398
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baduanjin With Resistance Training Program for Elderly Patients With Osteoporosis and Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT06853132
- Acronym / sponsor ID
- 2000039398
- Conditions
- Osteoporosis, Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Yale-China Association
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants in the control group will continue with their conventional post surgery treatment as follows: comprehensive post-operative care and educational handouts that include guidelines for lumbar and back exercises to improve recovery and promote spinal health. In addition, participants will receive three interactive Q\&A sessions before discharge (pre-operation, post-operation, and on the day of discharge). During these sessions, patients can discuss their concerns and ask questions about their recovery.
Participants in the experimental group will continue to receive their conventional post surgery treatment in addition to BDJ as follows: Individual session training (admission to week 1 post-surgery), no training week 2, Group session I (week 3 and 4), Group session 2 (week 5-12) and perform independent exercises during which participants will have to keep an exercise diary (week 13-24).
Data collection will be conducted through in-person visits at baseline and Week 1, followed by phone calls at Week 12 and Week 24.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Baduanjin with Resistance Training ProgramBDJ 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin with Resistance Training ProgramBaduanjin with Resistance Training Program | Behavioural | BDJ with resistance training |
Primary outcome
Change in Quality of life measured by the Oswestry Disability Index (ODI)
Time frame: Weeks 0, 1, 12, and 24
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.
Change in Muscle strength by the Five Times Sit-to-Stand Test (FTSS)
Time frame: Weeks 0, 1, 12, and 24
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.
Change in physical activity level by the International Physical Activity Questionnaire (IPAQ).
Time frame: Weeks 0, 1, 12, and 24
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.
3 secondary outcomes
Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE)
Time frame: Weeks 0, 1, 12, and 24
Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS)
Time frame: Weeks 0, 1, 12, and 24
Incidence of complications after surgery
Time frame: Week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
RecruitingObservational study
Bone Health in Adults With Duchenne Muscular Dystrophy: A Survey on Osteoporosis, Fractures and Treatment.
Duchenne Muscular Dystrophy (DMD)
RecruitingObservational study
REMS vs DXA for Osteoporosis Diagnosis and Fracture Risk Prediction
Osteoporosis Diagnosis, Bone Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin with Resistance Training Program in people with Osteoporosis and Lumbar Disc Herniation, run by Yale University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life measured by the Oswestry Disability Index (ODI) (time frame: Weeks 0, 1, 12, and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.