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Completed

NCT Number: NCT05164679

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

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.

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Key information

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal training (MMT)

Behavioral

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

Other names: Sedentary control group (CON)

Primary outcomes

  1. Whole-body and regional BMD

    Time frame: 19 weeks

    bone mineral density (g/cm2)

  2. Osteocalcin

    Time frame: 3 weeks and 19 weeks

    Concentration of Osteocalcin in plasma in fasted state (µg/l)

  3. P1NP

    Time frame: 3 weeks and 19 weeks

    Concentration of P1NP in plasma in fasted state (µg/l)

  4. CTX

    Time frame: 3 weeks and 19 weeks

    Concentration of CTX in plasma in fasted state (ng/l)

Secondary outcomes

  1. Body fat percentage

    Time frame: 19 weeks

    Body fat percentage (%)

  2. Visceral adipose tissue (VAT)

    Time frame: 19 weeks

    Volume (m3)

  3. Body weight

    Time frame: 19 weeks

    kg

  4. BMI

    Time frame: 19 weeks

    kg/m2

  5. Total fat mass

    Time frame: 19 weeks

    kg

  6. Total lean body mass (LBM)

    Time frame: 19 weeks

    kg

  7. Whole-body bone mineral content (BMC)

    Time frame: 19 weeks

    g

  8. dynamic balance

    Time frame: 19 weeks

    time to fulfill a four-square-balance test (sec)

  9. dynamic muscle strength

    Time frame: 19 weeks

    Jump-and-reach-test (cm)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2021
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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