Training in a Local Community Aimed Upon Musculoskeletal Health Promotion for Postmenopausal Women

Study Overview
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Brief Summary
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To minimize fracture risk, diverse and varied training of high intensity (multimodal training) is recommended to increase bone strength. However, the effectiveness of different training programmes performed in community settings remain uncertain. The present study aimed to evaluate the feasibility and the effectiveness of 19-week of multimodal training in a local community center in Copenhagen, Denmark. The health promotion initiative had special emphasis on musculoskeletal health in postmenopausal women.

Detailed Description
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A local community center was offering supervised multimodal training (MMT) to postmenopausal, healthy women twice weekly, and the aim of the present study was to evaluate the feasibility and the musculoskeletal health promoting effects of the training. The evaluation study lasted for 19 weeks, and the average attendance rate of MMT participants had to be > 1 hour weekly. The primary outcomes were bone mineral density (BMD) assessed by Dual-Energy X-ray Absorptiometry (DXA) scanning and the fasted plasma concentration of bone turnover markers (BTM): N-terminal propeptide of type I procollagen (P1NP) , C-terminal telopeptide of type I collagen (CTX), Osteocalcin), while secondary outcomes were body composition variables, dynamic postural balance and functional muscle strength. To test within- and between-group differences in the pre and post outcomes the training group (MMT) was compared with a sedentary control group (CON). Every participant was fully informed before giving her written informed consent to the procedures and potential discomfort associated with the study. The study was conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee of the Capital Region of Denmark, H-18044190.

Official Title
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A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion With Special Emphasis on Musculoskeletal Health Effects

Conditions
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Age-Related Osteoporosis

Intervention / Treatment
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* Behavioral: multimodal training (MMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: past menopause non-smoking BMI <30 kg/m2 Exclusion Criteria: T-score < -3 SD in the lumbar spine or hip Z-score > 1.5 SD) use of hormone therapy, medical treatment or supplements that affect bone metabolism previous or current medical condition affecting bone health engagement in regular and systemic weight-bearing training or strength training during the preceding two years

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate in the present study. Inclusion criteria were: non-smoker body mass index (BMI) <30 kg/m2. Exclusion criteria were: T-score < -3 SD in the lumbar spine or hip high BMD in relation to age (Z-score > 1.5 SD) use of hormone therapy, medical treatment, or supplements that affect bone metabolism previous or current medical condition affecting bone health engagement in regular and systematic weight-bearing training or strength training during the preceding two years. Initially, twenty women were recruited to the training via an online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a medical examination, one participant was excluded due to low BMD (T-score < -3 SD), and two were excluded due to high BMI (≥30 kg/m2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMT<br>Intervention group performing multimodal training (MMT) 1-2 hours weekly | Behavioral: multimodal training (MMT)<br>* Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks<br>* Other names: Sedentary control group (CON);|
| No Intervention: CON<br>Sedentary control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-body and regional BMD | bone mineral density (g/cm2) | 19 weeks | 
| Osteocalcin | Concentration of Osteocalcin in plasma in fasted state (µg/l) | 3 weeks and 19 weeks | 
| P1NP | Concentration of P1NP in plasma in fasted state (µg/l) | 3 weeks and 19 weeks | 
| CTX | Concentration of CTX in plasma in fasted state (ng/l) | 3 weeks and 19 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | Body fat percentage (%) | 19 weeks | 
| Visceral adipose tissue (VAT) | Volume (m3) | 19 weeks | 
| Body weight | kg | 19 weeks | 
| BMI | kg/m2 | 19 weeks | 
| Total fat mass | kg | 19 weeks | 
| Total lean body mass (LBM) | kg | 19 weeks | 
| Whole-body bone mineral content (BMC) | g | 19 weeks | 
| dynamic balance | time to fulfill a four-square-balance test (sec) | 19 weeks | 
| dynamic muscle strength | Jump-and-reach-test (cm) | 19 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion