Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program

NCT ID: NCT03570008

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-03-01

Brief 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. 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.

Conditions

Osteoporotic Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

9 days spa residential program

Intervention Type: BEHAVIORAL

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 exercise

Intervention Type: BEHAVIORAL

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.

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)

Group Type: ACTIVE_COMPARATOR

9 days spa residential program

Intervention Type: BEHAVIORAL

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.

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)

Group Type: ACTIVE_COMPARATOR

3 sessions of 10 minutes per day of physical exercise

Intervention Type: BEHAVIORAL

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.

Interventions

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:

• 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.

Intervention Type: 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:

• 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Council of Auvergne-Rhône-Alpes

OTHER

Sponsor Role: collaborator

European Regional Development Fund

OTHER

Sponsor Role: collaborator

Spa resort of Chaudes Aigues, 27 avenue Georges Pompidou, BP21, 15110 Chaudes Aigues, France

UNKNOWN

Sponsor Role: collaborator

Spa resort of Bourbon-Lancy, place d'Aligre 71140 Bourbon-Lancy, France

UNKNOWN

Sponsor Role: collaborator

Innovatherm

INDUSTRY

Sponsor Role: collaborator

Université d'Auvergne

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic DUTHEIL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick LACARIN

Role: CONTACT

placarin@chu-clermontferrand.fr

0473751195

Facility Contacts

Patrick LACARIN

Role: primary

placarin@chu-clermontferrand.fr

0473751195

Other Identifiers

2016-A02083-48

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-387

Identifier Type: -

Identifier Source: org_study_id