Clinical trial NCT06853132: Baduanjin With Resistance Training Program
Official title: Baduanjin With Resistance Training Program for Elderly Patients With Osteoporosis and Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporosis
Lumbar Disc Herniation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Yale-China Association
First posted: 2025-02-28
Enrollment: 110
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Quality of life measured by the Oswestry Disability Index (ODI)
timeFrame: Weeks 0, 1, 12, and 24
measure: Change in Muscle strength by the Five Times Sit-to-Stand Test (FTSS)
timeFrame: Weeks 0, 1, 12, and 24
measure: Change in physical activity level by the International Physical Activity Questionnaire (IPAQ).
timeFrame: Weeks 0, 1, 12, and 24
Secondary outcomes:
measure: Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE)
timeFrame: Weeks 0, 1, 12, and 24
measure: Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS)
timeFrame: Weeks 0, 1, 12, and 24
measure: Incidence of complications after surgery
timeFrame: Week 1
Other outcomes:
Locations:
city: Changsha City
country: China
facility: Second Xiangya Hospital
state: Hunan
Study officials:
affiliation: Yale University
name: Soohyun Nam, PhD, APRN, ANP-BC, FAHA, FAAN
role: PRINCIPAL_INVESTIGATOR
References: