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

Age-Related Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164679
• Other study ID #: Knoglestaerk
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Age-Related Osteoporosis
• Osteoporosis

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