Training in a Local Community Aimed Upon Musculoskeletal... | NCT05164679

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

NCT05164679

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Dec 21, 2021Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Age-Related Osteoporosis

Interventions

multimodal training (MMT)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2019Actual

Primary Completion Date

Jul 9, 2019Actual

Completion Date

Jul 9, 2019Actual

First Submitted Date

Dec 4, 2021

First Submission Date that Met QC Criteria

Dec 19, 2021

First Posted Date

Dec 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2021

Last Update Posted Date

Dec 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ewa Wulff Helge, Associate Professor, Ph.D., University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MMT	Experimental	Intervention group performing multimodal training (MMT) 1-2 hours weekly	Behavioral: multimodal training (MMT)
CON	No Intervention	Sedentary control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multimodal training (MMT)	Behavioral	Supervised multimodal exercise training (MMT) performed 1-2 hours weekly for 19 weeks	MMT

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Body fat percentage	Body fat percentage (%)	19 weeks
Visceral adipose tissue (VAT)	Volume (m3)	19 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva W Helge, Ph.D.	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Copenhagen, Department of Nutrition, Exercise and Sports		Copenhagen		2200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39263388	Derived	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.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases