Baduanjin With Resistance Training Program

Official title

Baduanjin With Resistance Training Program for Elderly Patients With Osteoporosis and Lumbar Disc Herniation

Overview

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.

Interventions

• Behavioral Baduanjin with Resistance Training Program
  Baduanjin with Resistance Training Program

Primary outcome measures

• Change in Quality of life measured by the Oswestry Disability Index (ODI) [Time frame: Weeks 0, 1, 12, and 24]
• Change in Muscle strength by the Five Times Sit-to-Stand Test (FTSS) [Time frame: Weeks 0, 1, 12, and 24]
• Change in physical activity level by the International Physical Activity Questionnaire (IPAQ). [Time frame: Weeks 0, 1, 12, and 24]

Secondary outcome measures (3)

• 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]

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.

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

China · 1 center

• Second Xiangya Hospital — Changsha

Identifiers

NCT: NCT06853132 · 2000039398

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗