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

Osteoporotic Fracture Clinical Trial

— ThermOs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03570008
• Other study ID #: CHU-387
• Secondary ID: 2016-A02083-48
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporotic Fracture
• Osteoporotic Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (7)

Lead Sponsor

Collaborator

University Hospital, Clermont-Ferrand

AME2P Laboratory (EA 3533), University Clermont Auvergne, Clermont-Ferrand, France, Auvergne Rhone Alpes Regional Council (Région Auvergne Rhône Alpes), Clermont-Ferrand, France, European Regional Development Fund (FEDER - Fonds Européen de Développement Economique et Régional), Innova-Therm, Auvergne, France, Spa resort of Bourbon-Lancy, place d’Aligre 71140 Bourbon-Lancy, France, Spa resort of Chaudes Aigues, 27 avenue Georges Pompidou, BP21, 15110 Chaudes Aigues, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	General Health	General Health will be measured using the General Health Questionnaire, (there is no score, just informative health information)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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.	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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))	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Calcium intake	Depression and anxiety will be measured using Hamilton scale (scale range from 0 to 4, if > 20 high level of anxiety)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Body mass	Body mass (muscle and fat) will be measured using Impedancemeter	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Anthropometry	weight (kg) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Anthropometry	height (m) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Anthropometry	waist circumference (cm) will be obtained according to the ISAK (International Society for the Advancement of Kinanthropometry) recommendations	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Basic biology	HbA1c (mmol/mol) will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Basic biology	HDLc (mmol/L) will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Basic biology	LDL-cholesterol (mmol/L) will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Basic biology	Triglyceride (TG-mmol/L) will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Vitamin D	Vitamin D will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Leptin	Leptin will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	Pro-inflammatory cytokine	Pro-inflammatory cytokine (IL-1ß, IL-6, IL-1, TNFa, IFN?) will be measured using endocrine assays	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	heart rate variability	heart rate variability will be measured using Holter	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	electrodermal activity	electrodermal activity (skin conductance) will be measured using Wirst band electrodes	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	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)	at Baseline, after 10 days, after 6 months, after 12 months
Secondary	physical activity behaviour	will be measured using an accelerometer-pedometer watch (daily step count)	at Baseline, after 10 days, after 6 months, after 12 months