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

NCT03570008 | Unknown

• 2 other identifiers: CHU-3872016-A02083-48
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fracture

Keywords

prevention; bone; physical activity; spa bath; women

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  after 12 months

Secondary Outcomes (26)

• 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

• 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

Study Arms (3)

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)

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)

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)

Behavioral: 3 sessions of 10 minutes per day of physical exercise

Interventions

9 days spa residential program 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-Ex; Sp-alone

3 sessions of 10 minutes per day of physical exercise 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; Sp-Ex

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with regular cycles
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Regional Council of Auvergne-Rhône-Alpes: collaborator
• European Regional Development Fund: collaborator
• Spa resort of Chaudes Aigues, 27 avenue Georges Pompidou, BP21, 15110 Chaudes Aigues, France: collaborator
• Spa resort of Bourbon-Lancy, place d'Aligre 71140 Bourbon-Lancy, France: collaborator
• Innovatherm: collaborator
• Université d'Auvergne: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Osteoporotic Fractures; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Frederic DUTHEIL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: June 26, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

FR (1)