Osteoporotic FractureThermOsNCT03570008
Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program
A study testing 9 days spa residential program and 3 sessions of 10 minutes per day of physical exercise in people with Osteoporotic Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fracture
- What is being tested?
- 9 days spa residential program and 3 sessions of 10 minutes per day of physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Frederic DUTHEIL
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Osteoporotic Fracture
- Being tested
- 9 days spa residential program, 3 sessions of 10 minutes per day of physical exercise
- Keywords
- prevention, bone, physical activity, spa bath, women
- Medical subject headings
- Osteoporotic Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9 days spa residential programBehavioural
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:
- Sp-Ex: spa residential program including physical activity
- Sp-alone: spa residential program alone
- Ex-alone: physical activity alone
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.
3 sessions of 10 minutes per day of physical exerciseBehavioural
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:
- Sp-Ex: spa residential program including physical activity
- Sp-alone: spa residential program alone
- Ex-alone: physical activity alone
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.
| Study group | Role | What they receive |
|---|---|---|
| Sp-Ex | Experimental | 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) Receives: Behavioral: 9 days spa residential program; Behavioral: 3 sessions of 10 minutes per day of physical exercise |
| Sp-alone | Active comparator | 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) Receives: Behavioral: 9 days spa residential program |
| Ex-alone | Active comparator | 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) Receives: Behavioral: 3 sessions of 10 minutes per day of physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of bone cortical porosity in premenopausal women after the interventional phase.
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.
Measured: at Baseline
Variation of bone cortical porosity in premenopausal women
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.
Measured: after 10 days
Variation of bone cortical porosity in premenopausal women
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.
Measured: after 6 months
Variation of bone cortical porosity in premenopausal women
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.
Measured: after 12 months
Secondary outcomes (26)
bone fracture risk
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)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
General Health
General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)
Measured: 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).
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.
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Physical Activity
Quality of life will be measured using the SF-36 (Short Form 36 ; 9 sections questionnaire ; scale range from 0 (bad) to 100(excellent))
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Quality of life
Calcium intake will be measured using the Fardellonne questionnaire (recommended daily consummation in France: women 900 mg/d; women >55 years old 1200mg/d)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Calcium intake
Depression and anxiety will be measured using Hamilton scale (scale range from 0 to 4, if > 20 high level of anxiety)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Depression and anxiety
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)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Depression and anxiety
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)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Anxiety
Burn-out will be measured using the Maslach Burn Out Inventory (scale range from 0 to 6, with 0 = never and 6 = almost always)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Burn-out
Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Job content
Job content will be measured using the Karasek questionnaire (scale range from 1 to 4, with 1= not agreed and 4 = totally agreed)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Body mass
Body mass (muscle and fat) will be measured using Impedancemeter
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
weight (kg) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
height (m) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
waist circumference (cm) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
HbA1c (mmol/mol) will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
HDLc (mmol/L) will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
LDL-cholesterol (mmol/L) will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
Triglyceride (TG-mmol/L) will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Vitamin D
Vitamin D will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Leptin
Leptin will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Pro-inflammatory cytokine
Pro-inflammatory cytokine (IL-1β, IL-6, IL-1, TNFα, IFNγ) will be measured using endocrine assays
Measured: at Baseline, after 10 days, after 6 months, after 12 months
heart rate variability
heart rate variability will be measured using Holter
Measured: at Baseline, after 10 days, after 6 months, after 12 months
electrodermal activity
electrodermal activity (skin conductance) will be measured using Wirst band electrodes
Measured: at Baseline, after 10 days, after 6 months, after 12 months
physical activity behaviour
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)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
physical activity behaviour
will be measured using an accelerometer-pedometer watch (daily step count)
Measured: at Baseline, after 10 days, after 6 months, after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Mar 2017
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Chaudes Aigues, 27 avenue Georges Pompidou, BP21, 15110 Chaudes Aigues, France, Spa resort of Bourbon-Lancy, place d'Aligre 71140 Bourbon-Lancy, France, Innovatherm, Université d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570008
- Sponsor's protocol ID
- CHU-387
- Other IDs
- 2016-A02083-48
- Acronym
- ThermOs
- Status last verified
- Jun 2018
- First submitted
- 26 Mar 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program
- ClinicalTrials.gov ID
- NCT03570008
- Acronym / sponsor ID
- ThermOs / CHU-387
- Conditions
- Osteoporotic Fracture
- Keywords
- prevention, bone, physical activity, spa bath, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Chaudes Aigues, 27 avenue Georges Pompidou, BP21, 15110 Chaudes Aigues, France, Spa resort of Bourbon-Lancy, place d'Aligre 71140 Bourbon-Lancy, France, Innovatherm, Université d'Auvergne
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sp-Ex | Experimental | Behavioral: 9 days spa residential program, Behavioral: 3 sessions of 10 minutes per day of physical exercisea 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) |
| Sp-alone | Active comparator | Behavioral: 9 days spa residential programParticipants 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) |
| Ex-alone | Active comparator | Behavioral: 3 sessions of 10 minutes per day of physical exerciseParticipants 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) |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women with regular cycles
- 40-50 years old
- Sedentary lifestyle
- stable body weight over the previous 6 months
- Normal weighted (BMI<30)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9 days spa residential programAfter 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: * Sp-Ex: spa residential program including physical activity * Sp-alone: spa residential program alone * Ex-alone: physical activity alone 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. | Behavioural | Sp-Ex, Sp-alone |
| 3 sessions of 10 minutes per day of physical exerciseAfter 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: * Sp-Ex: spa residential program including physical activity * Sp-alone: spa residential program alone * Ex-alone: physical activity alone 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. | Behavioural | Ex-alone, Sp-Ex |
Primary outcome
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.
26 secondary outcomes
bone fracture risk
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
General Health
Time frame: 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).
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Physical Activity
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Quality of life
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Calcium intake
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Depression and anxiety
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Depression and anxiety
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Anxiety
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Burn-out
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Job content
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Body mass
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Anthropometry
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Basic biology
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Vitamin D
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Leptin
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Pro-inflammatory cytokine
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
heart rate variability
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
electrodermal activity
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
physical activity behaviour
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
physical activity behaviour
Time frame: at Baseline, after 10 days, after 6 months, after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 9 days spa residential program and 3 sessions of 10 minutes per day of physical exercise in people with Osteoporotic Fracture, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of bone cortical porosity in premenopausal women after the interventional phase. (time frame: at Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.