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

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

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.

Study Overview

• Status: Completed
• Conditions: Age-Related Osteoporosis
• Intervention / Treatment: Behavioral: multimodal training (MMT)

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • University of Copenhagen, Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMT; Intervention group performing multimodal training (MMT) 1-2 hours weekly	Behavioral: multimodal training (MMT); Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks; Other Names: Sedentary control group (CON)
No Intervention: CON; Sedentary control group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Eva W Helge, Ph.D., University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 19, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: menopause; resistance exercise; Bone mineral density; health promotion; bone turnover marker; high-impact; odd-impact
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: Knoglestaerk

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No