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

Primary Purpose

Age-Related Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
multimodal training (MMT)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-Related Osteoporosis focused on measuring Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MMT

CON

Arm Description

Intervention group performing multimodal training (MMT) 1-2 hours weekly

Sedentary control group

Outcomes

Primary Outcome Measures

Whole-body and regional BMD
bone mineral density (g/cm2)
Osteocalcin
Concentration of Osteocalcin in plasma in fasted state (µg/l)
P1NP
Concentration of P1NP in plasma in fasted state (µg/l)
CTX
Concentration of CTX in plasma in fasted state (ng/l)

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2021
Last Updated
December 19, 2021
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05164679
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Osteoporosis
Keywords
Bone mineral density, bone turnover marker, high-impact, odd-impact, resistance exercise, menopause, health promotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MMT
Arm Type
Experimental
Arm Description
Intervention group performing multimodal training (MMT) 1-2 hours weekly
Arm Title
CON
Arm Type
No Intervention
Arm Description
Sedentary control group
Intervention Type
Behavioral
Intervention Name(s)
multimodal training (MMT)
Other Intervention Name(s)
Sedentary control group (CON)
Intervention Description
Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks
Primary Outcome Measure Information:
Title
Whole-body and regional BMD
Description
bone mineral density (g/cm2)
Time Frame
19 weeks
Title
Osteocalcin
Description
Concentration of Osteocalcin in plasma in fasted state (µg/l)
Time Frame
3 weeks and 19 weeks
Title
P1NP
Description
Concentration of P1NP in plasma in fasted state (µg/l)
Time Frame
3 weeks and 19 weeks
Title
CTX
Description
Concentration of CTX in plasma in fasted state (ng/l)
Time Frame
3 weeks and 19 weeks
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
Body fat percentage (%)
Time Frame
19 weeks
Title
Visceral adipose tissue (VAT)
Description
Volume (m3)
Time Frame
19 weeks
Title
Body weight
Description
kg
Time Frame
19 weeks
Title
BMI
Description
kg/m2
Time Frame
19 weeks
Title
Total fat mass
Description
kg
Time Frame
19 weeks
Title
Total lean body mass (LBM)
Description
kg
Time Frame
19 weeks
Title
Whole-body bone mineral content (BMC)
Description
g
Time Frame
19 weeks
Title
dynamic balance
Description
time to fulfill a four-square-balance test (sec)
Time Frame
19 weeks
Title
dynamic muscle strength
Description
Jump-and-reach-test (cm)
Time Frame
19 weeks

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva W Helge, Ph.D.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Nutrition, Exercise and Sports
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

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

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