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

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT05164679

Collaborator

(none)

Enrollment

Location

Arms

6.1

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Osteoporosis	Behavioral: multimodal training (MMT)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate in the present study. Inclusion criteria were: non-smoker body mass index (BMI) <30 kg/m2. Exclusion criteria were: T-score < -3 SD in the lumbar spine or hip high BMD in relation to age (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 systematic weight-bearing training or strength training during the preceding two years. Initially, twenty women were recruited to the training via an online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a medical examination, one participant was excluded due to low BMD (T-score < -3 SD), and two were excluded due to high BMI (≥30 kg/m2).Healthy, sedentary postmenopausal women aged below 70 years were eligible to participate in the present study.Inclusion criteria were:non-smoker body mass index (BMI) <30 kg/m2.Exclusion criteria were:T-score < -3 SD in the lumbar spine or hip high BMD in relation to age (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 systematic weight-bearing training or strength training during the preceding two years. Initially, twenty women were recruited to the training via an online advertisement and a local newspaper, but only 19 showed up for pre-testing. After a medical examination, one participant was excluded due to low BMD (T-score < -3 SD), and two were excluded due to high BMI (≥30 kg/m2).

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 4, 2019

Actual Primary Completion Date :

Jul 9, 2019

Actual Study Completion Date :

Jul 9, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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