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

NCT ID: NCT05164679

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-04

Study Completion Date

2019-07-09

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.

Conditions

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Age-Related Osteoporosis

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MMT

Intervention group performing multimodal training (MMT) 1-2 hours weekly

Group Type EXPERIMENTAL

multimodal training (MMT)

Intervention Type BEHAVIORAL

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

CON

Sedentary control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multimodal training (MMT)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Sedentary control group (CON)

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
Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Ewa Wulff Helge

Associate Professor, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva W Helge, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Prawiradilaga RS, Bendtsen M, Esrup S, Jorgensen NR, Yulianto FA, Helge EW. Feasibility Study of Community-Based Training for Musculoskeletal Health Promotion. F1000Res. 2024 Sep 4;11:51. doi: 10.12688/f1000research.73698.3. eCollection 2022.

Reference Type DERIVED
PMID: 39263388 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Knoglestaerk

Identifier Type: -

Identifier Source: org_study_id