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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05164679
Other study ID # Knoglestaerk
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2019
Est. completion date July 9, 2019

Study information

Verified date December 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date July 9, 2019
Est. primary completion date July 9, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark University of Copenhagen, Department of Nutrition, Exercise and Sports Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole-body and regional BMD bone mineral density (g/cm2) 19 weeks
Primary Osteocalcin Concentration of Osteocalcin in plasma in fasted state (µg/l) 3 weeks and 19 weeks
Primary P1NP Concentration of P1NP in plasma in fasted state (µg/l) 3 weeks and 19 weeks
Primary CTX Concentration of CTX in plasma in fasted state (ng/l) 3 weeks and 19 weeks
Secondary Body fat percentage Body fat percentage (%) 19 weeks
Secondary Visceral adipose tissue (VAT) Volume (m3) 19 weeks
Secondary Body weight kg 19 weeks
Secondary BMI kg/m2 19 weeks
Secondary Total fat mass kg 19 weeks
Secondary Total lean body mass (LBM) kg 19 weeks
Secondary Whole-body bone mineral content (BMC) g 19 weeks
Secondary dynamic balance time to fulfill a four-square-balance test (sec) 19 weeks
Secondary dynamic muscle strength Jump-and-reach-test (cm) 19 weeks
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