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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05164679
Enrollment
28
Registered
2021-12-21
Start date
2019-01-04
Completion date
2019-07-09
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Osteoporosis

Keywords

Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion

Brief summary

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

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.

Interventions

BEHAVIORALmultimodal training (MMT)

Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Whole-body and regional BMD19 weeksbone mineral density (g/cm2)
Osteocalcin3 weeks and 19 weeksConcentration of Osteocalcin in plasma in fasted state (µg/l)
P1NP3 weeks and 19 weeksConcentration of P1NP in plasma in fasted state (µg/l)
CTX3 weeks and 19 weeksConcentration of CTX in plasma in fasted state (ng/l)

Secondary

MeasureTime frameDescription
Total fat mass19 weekskg
Total lean body mass (LBM)19 weekskg
Body fat percentage19 weeksBody fat percentage (%)
dynamic balance19 weekstime to fulfill a four-square-balance test (sec)
dynamic muscle strength19 weeksJump-and-reach-test (cm)
Whole-body bone mineral content (BMC)19 weeksg
Visceral adipose tissue (VAT)19 weeksVolume (m3)
Body weight19 weekskg
BMI19 weekskg/m2

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026