NCT05164679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

December 4, 2021

Last Update Submit

December 19, 2021

Conditions

Keywords

Bone mineral densitybone turnover markerhigh-impactodd-impactresistance exercisemenopausehealth promotion

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (9)

  • Body fat percentage

    19 weeks

  • Visceral adipose tissue (VAT)

    19 weeks

  • Body weight

    19 weeks

  • BMI

    19 weeks

  • Total fat mass

    19 weeks

  • +4 more secondary outcomes

Study Arms (2)

MMT

EXPERIMENTAL

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

Behavioral: multimodal training (MMT)

CON

NO INTERVENTION

Sedentary control group

Interventions

Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks

Also known as: Sedentary control group (CON)
MMT

Eligibility Criteria

AgeUp to 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • past menopause
  • non-smoking
  • BMI \<30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 2200, Denmark

Location

Related Publications (1)

  • Prawiradilaga RS, Bendtsen M, Esrup S, Jorgensen NR, Yulianto FA, Helge EW. Feasibility Study of Community-Based Training for Musculoskeletal Health Promotion. F1000Res. 2024 Sep 4;11:51. doi: 10.12688/f1000research.73698.3. eCollection 2022.

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eva W Helge, Ph.D.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Ph.D.

Study Record Dates

First Submitted

December 4, 2021

First Posted

December 21, 2021

Study Start

January 4, 2019

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations