Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program (ThermOs)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03570008 |
|
Recruitment Status : Unknown
Verified June 2018 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : June 26, 2018
Last Update Posted : June 26, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoporotic Fracture | Behavioral: 9 days spa residential program Behavioral: 3 sessions of 10 minutes per day of physical exercise | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Masking Description: | No masking |
| Primary Purpose: | Prevention |
| Official Title: | Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program |
| Actual Study Start Date : | March 1, 2017 |
| Estimated Primary Completion Date : | March 1, 2021 |
| Estimated Study Completion Date : | March 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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)
|
Behavioral: 9 days spa residential program
After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves. A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts. Behavioral: 3 sessions of 10 minutes per day of physical exercise After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves. A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts. |
|
Active Comparator: 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)
|
Behavioral: 9 days spa residential program
After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves. A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts. |
|
Active Comparator: 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)
|
Behavioral: 3 sessions of 10 minutes per day of physical exercise
After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves. A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts. |
- Variation of bone cortical porosity in premenopausal women after the interventional phase. [ Time Frame: 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 [ Time Frame: after 10 days ]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 [ Time Frame: after 6 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.
- Variation of bone cortical porosity in premenopausal women [ Time Frame: 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.
- bone fracture risk [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]questionnaire (FRAX - Fracture Risk Assessment Tool, bone fracture risks ; after registering results from DXA and personal details the computer calculates the fracture risks based on an algorithm)
- General Health [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)
- 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). [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Evaluate the effectiveness of the Sp-Ex program compared with the Sp-alone or Ex-alone on short-term modification of health factors among premenopausal women.
- Physical Activity [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Quality of life will be measured using the SF-36 (Short Form 36 ; 9 sections questionnaire ; scale range from 0 (bad) to 100(excellent))
- Quality of life [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Calcium intake will be measured using the Fardellonne questionnaire (recommended daily consummation in France: women 900 mg/d; women >55 years old 1200mg/d)
- Calcium intake [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Depression and anxiety will be measured using Hamilton scale (scale range from 0 to 4, if > 20 high level of anxiety)
- Depression and anxiety [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Depression and anxiety will be measured using the Hospital anxiety and depression scale (scale range from 0 to 3, with a total score between 0 to 21. Threshold score is 8)
- Depression and anxiety [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]anxiety will be measured using the state and trait anxiety inventory scale (scale range from 1 to 4, with a total score between 20 to 80. If <35 poor level of anxiety, if > 66 very high level of anxiety)
- Anxiety [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Burn-out will be measured using the Maslach Burn Out Inventory (scale range from 0 to 6, with 0 = never and 6 = almost always)
- Burn-out [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)
- Job content [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)
- Body mass [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Body mass (muscle and fat) will be measured using Impedancemeter
- Anthropometry [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]weight (kg) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
- Anthropometry [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]height (m) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
- Anthropometry [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]waist circumference (cm) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
- Basic biology [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]HbA1c (mmol/mol) will be measured using endocrine assays
- Basic biology [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]HDLc (mmol/L) will be measured using endocrine assays
- Basic biology [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]LDL-cholesterol (mmol/L) will be measured using endocrine assays
- Basic biology [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Triglyceride (TG-mmol/L) will be measured using endocrine assays
- Vitamin D [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Vitamin D will be measured using endocrine assays
- Leptin [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Leptin will be measured using endocrine assays
- Pro-inflammatory cytokine [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]Pro-inflammatory cytokine (IL-1β, IL-6, IL-1, TNFα, IFNγ) will be measured using endocrine assays
- heart rate variability [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]heart rate variability will be measured using Holter
- electrodermal activity [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]electrodermal activity (skin conductance) will be measured using Wirst band electrodes
- physical activity behaviour [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]physical activity behaviour will be measured using an activity journal (participant will have to write all their daily activity from when they wake up to when they go to bed)
- physical activity behaviour [ Time Frame: at Baseline, after 10 days, after 6 months, after 12 months ]will be measured using an accelerometer-pedometer watch (daily step count)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570008
| Contact: Patrick LACARIN | 0473751195 | placarin@chu-clermontferrand.fr |
| France | |
| CHU Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr | |
| Principal Investigator: Frederic DUTHEIL | |
| Principal Investigator: | Frederic DUTHEIL | University Hospital, Clermont-Ferrand |
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT03570008 |
| Other Study ID Numbers: |
CHU-387 2016-A02083-48 ( Other Identifier: 2016-A02083-48 ) |
| First Posted: | June 26, 2018 Key Record Dates |
| Last Update Posted: | June 26, 2018 |
| Last Verified: | June 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
prevention bone physical activity spa bath women |
|
Fractures, Bone Osteoporotic Fractures Wounds and Injuries |