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临床试验/NCT05164679
NCT05164679已完成不适用

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

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Whole-body and regional BMD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • past menopause
  • non-smoking
  • BMI <30 kg/m2

排除标准

  • 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

结局指标

主要结局

Whole-body and regional BMD

时间窗: 19 weeks

bone mineral density (g/cm2)

Osteocalcin

时间窗: 3 weeks and 19 weeks

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

P1NP

时间窗: 3 weeks and 19 weeks

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

CTX

时间窗: 3 weeks and 19 weeks

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

次要结局

  • Body weight(19 weeks)
  • Body fat percentage(19 weeks)
  • Visceral adipose tissue (VAT)(19 weeks)
  • BMI(19 weeks)
  • Total fat mass(19 weeks)
  • dynamic balance(19 weeks)
  • Total lean body mass (LBM)(19 weeks)
  • Whole-body bone mineral content (BMC)(19 weeks)
  • dynamic muscle strength(19 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ewa Wulff Helge

Associate Professor, Ph.D.

University of Copenhagen

研究点 (2)

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