Clinical trial NCT05164679: Training in a Local Community Aimed Upon Musculoskeletal Health Promotion for Postmenopausal Women
Official title: A Feasibility Study of Training in a Local Community Aimed Upon Health Promotion With Special Emphasis on Musculoskeletal Health Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Osteoporosis
Keywords: Bone mineral density
bone turnover marker
high-impact
odd-impact
resistance exercise
menopause
health promotion
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 28
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole-body and regional BMD
timeFrame: 19 weeks
measure: Osteocalcin
timeFrame: 3 weeks and 19 weeks
measure: P1NP
timeFrame: 3 weeks and 19 weeks
measure: CTX
timeFrame: 3 weeks and 19 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 19 weeks
measure: Visceral adipose tissue (VAT)
timeFrame: 19 weeks
measure: Body weight
timeFrame: 19 weeks
measure: BMI
timeFrame: 19 weeks
measure: Total fat mass
timeFrame: 19 weeks
measure: Total lean body mass (LBM)
timeFrame: 19 weeks
measure: Whole-body bone mineral content (BMC)
timeFrame: 19 weeks
measure: dynamic balance
timeFrame: 19 weeks
measure: dynamic muscle strength
timeFrame: 19 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Nutrition, Exercise and Sports
Study officials:
affiliation: University of Copenhagen
name: Eva W Helge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: