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

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.

Conditions

• Osteoporotic Fracture

Interventions

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: * 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.

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.

Sponsors & Collaborators

• Regional Council of Auvergne-Rhône-Alpes

  collaborator OTHER

• European Regional Development Fund

  collaborator OTHER

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Innovatherm

  collaborator INDUSTRY

• Université d'Auvergne

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Frederic DUTHEIL · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-01

Primary Completion

2021-03-01

Completion

2021-03-01

Countries

• France

Study Locations