Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Variation of bone cortical porosity in premenopausal women after the interventional phase.
研究概览
简要总结
Osteoporosis is an increasing public health problem. Involution of bone mass in women is due to a reduction in sensitivity of the bone to the mechanical stress due to the slow-down of the bone turnover after 35 years old. Osteoporosis is a silent disease combining a decrease in bone mass (quantity) and an impaired bone microarchitecture (quality) leading to an increased risk of fracture. Bone microarchitecture is an important element to be taken into account in assessing the bone properties, as demonstrated by numerous ex vivo studies.
Bone densitometry only identifies 50% of osteoporotic fractures. The other half of the fractures appears in osteopenic women. The measurement of bone mineral density is too limited to assess risk of fracture. Bone microarchitecture can be assessed through a peripheral quantitative computed tomography scan (computed tomography peripherical - pQCT). The microarchitecture data allow the calculation of bone strength index (BSI) and stress strength index (SSI) highly predictive of fracture risk. These qualitative determinants of bone fragility are the most relevant to evaluate effect of physical activity over a short period compared with bone mineral content and density, which requires several months of constraints. Biochemical markers of bone turnover, specifically those of bone resorption, are predictive of the risk of osteoporotic fracture.
Physical activity can reduce the risk of fracture up to 20-35% via direct effects on bone strength, at any age. However, response of bone varies with modalities of exercise. Repeated exercise produces greater bone adaptations than a single bout. Moreover, it has been well demonstrated since 1970 that bone responds to a dynamic stimulation, but not a static stimulation, with a dose response relationship. It has been confirmed in premenopausal women.
The effect of physical activity on microarchitectural bone parameters (porosity and density of cortical and trabecular) has not been investigated in primary prevention. This original study would highlight the effect of short-term specific physical activity on the prevention of bone fragility (qualitative) observed with age in premenopausal women.
The main hypothesis is that a spa residential program including physical activity will have greater benefits on bone cortical porosity than a spa residential program alone or physical activity alone, in premenopausal women.
详细描述
The ThermOs protocol was designed to provide a better understanding of the effect of physical activity on microarchitectural bone parameters (porosity and density of cortical and trabecular), in prevention of bone fragility among premenopausal women.
In the present protocol, parameters are measured on four occasions (baseline, 10 days, at 6 months and at 12 months).
Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions.
Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.
Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used. Linear regression (with logarithmic transformation if necessary) considering an adjustment on covariates fixed according to epidemiological relevance and observance to physical activity will complete the analysis. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman) and compared with Chi-squared or Fischer test. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.
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
盲法说明
No masking
入排标准
- 年龄范围
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with regular cycles
- •40-50 years old
- •Sedentary lifestyle
- •stable body weight over the previous 6 months
- •Normal weighted (BMI<30)
- •written informed consent.
- •Affiliated to French health care system (for France)
排除标准
- •Menopausal women
- •Regular physical activity > 4 hours / week of moderate or high intensities
- •Participant refusal to participate
- •Hepatic, renal, or psychiatric diseases, nor cardiovascular or endocrine diseases (thyroid diseases will be included)
- •HIV infection
- •Use of medications altering body weight, corticosteroids, Nonsteroidal anti-inflammatory drugs
- •Use of medications influencing bone parameters such as bisphosphonate, other osteoporotic treatment therapy, or chemotherapy
- •Regular alcohol consumption (>20g of alcohol per day)
- •Restricted diet over the previous 6 months
- •Deficit or supplementation in vitamin D
- •Protected persons are not excluded
研究组 & 干预措施
Sp-Ex
a 9 days spa residential program including physical activity. 3 sessions of 10 minutes per day of physical exercise for bone health improvements supervised by a professional of adapted physical activity. Participants will benefit advices from national plan for physical activity and nutrition (NPPN)
干预措施: 9 days spa residential program (Behavioral)
Sp-Ex
a 9 days spa residential program including physical activity. 3 sessions of 10 minutes per day of physical exercise for bone health improvements supervised by a professional of adapted physical activity. Participants will benefit advices from national plan for physical activity and nutrition (NPPN)
干预措施: 3 sessions of 10 minutes per day of physical exercise (Behavioral)
Sp-alone
Participants will benefit a short term spa residential program of 9 days. In addition they will benefit advices from national plan for physical activity and nutrition (NPPN)
干预措施: 9 days spa residential program (Behavioral)
Ex-alone
Participants will benefit 3 sessions of 10 minutes per day of physical exercise for bone health improvements supervised by a professional of adapted physical activity. Participants will benefit advices from national plan for physical activity and nutrition (NPPN)
干预措施: 3 sessions of 10 minutes per day of physical exercise (Behavioral)
结局指标
主要结局
Variation of bone cortical porosity in premenopausal women after the interventional phase.
时间窗: at Baseline
To evaluate the effectiveness of a spa residential program including physical activity (Sp-Ex) on bone cortical porosity compared with a spa residential program alone (Sp-alone) or physical activity alone (Ex-alone), in premenopausal women.
Variation of bone cortical porosity in premenopausal women
时间窗: after 12 months
To evaluate the effectiveness of a spa residential program including physical activity (Sp-Ex) on bone cortical porosity compared with a spa residential program alone (Sp-alone) or physical activity alone (Ex-alone), in premenopausal women.
次要结局
- bone fracture risk(at Baseline, after 10 days, after 6 months, after 12 months)
- General Health(at Baseline, after 10 days, after 6 months, after 12 months)
- Calcium intake(at Baseline, after 10 days, after 6 months, after 12 months)
- Body mass(at Baseline, after 10 days, after 6 months, after 12 months)
- Greater short-term benefits on health factors with the Sp-Ex program than with Sp-alone or Ex-alone (Bone health will be obtained from the combination of 5 measures).(at Baseline, after 10 days, after 6 months, after 12 months)
- Physical Activity(at Baseline, after 10 days, after 6 months, after 12 months)
- Quality of life(at Baseline, after 10 days, after 6 months, after 12 months)
- Anxiety(at Baseline, after 10 days, after 6 months, after 12 months)
- Burn-out(at Baseline, after 10 days, after 6 months, after 12 months)
- Job content(at Baseline, after 10 days, after 6 months, after 12 months)
- Pro-inflammatory cytokine(at Baseline, after 10 days, after 6 months, after 12 months)
- electrodermal activity(at Baseline, after 10 days, after 6 months, after 12 months)
- Vitamin D(at Baseline, after 10 days, after 6 months, after 12 months)
- heart rate variability(at Baseline, after 10 days, after 6 months, after 12 months)
- Leptin(at Baseline, after 10 days, after 6 months, after 12 months)
- Depression and anxiety(at Baseline, after 10 days, after 6 months, after 12 months)
- Anthropometry(at Baseline, after 10 days, after 6 months, after 12 months)
- Basic biology(at Baseline, after 10 days, after 6 months, after 12 months)
- physical activity behaviour(at Baseline, after 10 days, after 6 months, after 12 months)