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临床试验/NCT06529172
NCT06529172已完成不适用

Effects of Resistance Training, Yijinjing and Baduanjin Exercise on Bone Mineral Density and Bone Metabolism in Older Women

Cheng Liang1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2023年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Dual-energy X-ray absorptiometry measurements

研究概览

简要总结

The objective of this study is to assess the impact of different exercise interventions on bone mineral density (BMD) in older women. It will also evaluate the safety and compliance of these interventions. The primary questions it aims to address are:

Does resistance training, Yijinjing, or Baduanjin improve BMD in postmenopausal women? What are the compliance rates and any adverse effects associated with these exercise programs? Participants will be divided into 4 groups and compared against a control group that maintains their usual lifestyle.

Participants will:

Engage in their assigned exercise program three times a week for 24 weeks Receive calcium and vitamin D supplementation daily Keep a log of exercise adherence and any side effects experienced The study will utilize the International Physical Activity Questionnaire and dual-energy X-ray absorptiometry for comprehensive assessments.

详细描述

The calculation revealed that a minimum number of 80 participants was required. In this study, the investigators employed a straightforward randomization method for group allocation. This study designated four sets of cards numbered 1 to 4, with each number representing one of the groups: RT group (RG), YJJ group (YG), BDJ group (BG) and control group (CG). Each set included 23 cards, and participants were assigned to groups using a draw from these sets, ensuring random and equal distribution across groups.

Participants were required to engage in exercise sessions conducted in a centralized manner, with three 60-minute sessions per week. The investigators did indeed monitor and document the compliance of the participants. Compliance encompassed adherence to the exercise regimen, intake of supplements, and compliance with all other research requirements. The majority of participants demonstrated good compliance throughout the 24-week study period.

Exercise intervention The initial exercise intervention was provided as follows: throughout the entire intervention period, the four groups of participants were administered calcium and vitamin D supplementation (produced by Wyeth Pharmaceuticals; specification: 600 mg per tablet; National Medicine Permission No. H10950029, once in the morning and once in the evening, one tablet each time). During the intervention period, participants were advised to avoid smoking and the consumption of alcohol, coffee, strong tea, and carbonated drinks. The CG group maintained their original lifestyle without engaging in regular exercise. The intervention period lasted for 24 weeks with a frequency of three times per week. Each session lasted for 60 min and included approximately 10 min of preparatory activities, warm-up and relaxation. Exercise intensity was based on the research method by Cheng et al. with the heart rate controlled at (220 - age) × (55% to 70%). After each exercise session, the carotid pulse was recorded by manually counting the beats over a 30-second period post-exercise, using this data to adjust the exercise intensity if it deviated from the target heart rate range.

RG performed RT with an elastic band (yellow, force of 9-11 pounds when stretched twice the original length). They performed eight movements. Each movement was performed for 3-5 sets at 8 times/sets with 30 s of rest between groups. The movements included upright rows, reverse curls, standing shoulder rotations, neck-elbow extensions, elbow bends, downward lunges, standing leg lifts, side lifts and standing back kicks. All participants completed the RT movements according to the regular rhythm (1-2-1) provided by the experimenter, which ensured that all participants had similar movements completion rates.

YG performed 12 movements. These movements included extending the hands upwards and slowly lowering them; extending the torso by stretching the hands straight up and bending the body to the left or right; squatting with the hands on the knees and standing up slowly; bending the body to the left or right side, extending the arms and waist; getting down on the knees, leaning forward, extending the hands forward and slowly pulling them back; bending forward, placing the hands around the knees and standing up slowly; placing the hands on the hips; and leaning back to stretch the back and waist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females who were aged 60-70 years
  • Recently expressed willingness to engage in fitness activities
  • Passed a health examination
  • Signed an informed consent form in accordance with the Helsinki Declaration were included.

排除标准

  • Heart disease
  • History of severe lower limb injury
  • A T-score of less than -2.5 standard deviations is diagnostic of osteoporosis
  • Currently taking antiosteoporosis medication
  • Currently taking hormone replacement therapy
  • Engaging in other regular forms of exercise were excluded.

结局指标

主要结局

Dual-energy X-ray absorptiometry measurements

时间窗: 24 Weeks

A Norland XR-46 dual-energy X-ray BMD tester was used to measure the BMD of the lumbar L2-4 and proximal femur of the dominant side (femur neck, greater trochanter and Ward's triangle). Five non-re-entrant scans were performed at each measurement site. The error coefficients of the measurement location were 1-2% in the lumbar L2-4, femoral neck and greater trochanter and 2.5-5% in Ward's triangle. The coefficient of variation in the lumbar vertebrae and the proximal femur was 1.1% and 1.85%, respectively.

Serum bone metabolism markers

时间窗: 24 Weeks

Fasting venous blood (5 ml) was drawn between 7 a.m. and 8 a.m. at both baseline and after 24 weeks, with samples subsequently centrifuged at 3000 r/min for 5 minutes in each instance. Serum levels of PINP, OC, and β-CTX were measured using an automatic chemiluminescence analyzer, the LIAISON® XL, which is manufactured by the Italian company DiaSorin. The kit required for the experiment was purchased from Nanjing Jiancheng Bioengineering Institute and utilised in strict accordance with its instructions.

次要结局

  • Physical Activity Assessment(24 Weeks)

研究者

发起方
Cheng Liang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cheng Liang

Pro

Chengdu Sport University

研究点 (1)

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