Baduanjin With Resistance Training Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Baduanjin with Resistance Training Program
  Baduanjin with Resistance Training Program

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in Exercise self-efficacy by the Self-Efficacy for Exercise Scale (SEE) [Срок оценки: Weeks 0, 1, 12, and 24]
• Change in exercise benefit by the Exercise Benefits and Barriers Scale (EBBS) [Срок оценки: Weeks 0, 1, 12, and 24]
• Incidence of complications after surgery [Срок оценки: Week 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Second Xiangya Hospital — Чанша

Идентификаторы

NCT: NCT06853132 · 2000039398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗