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

Not Applicable

Completed

• Conditions: Age-Related Osteoporosis
• Interventions: Behavioral: multimodal training (MMT)

• Registration Number: NCT05164679
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2019-01-04
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Status Verified: 2021-12
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-19
• Last Update Submitted: 2021-12-19
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Denmark