NCT03683849

Brief Summary

This study evaluates physiological measurements and their role in among falls in healthy elderly (65yr or older) or elderly suffering from osteoporosis. The study further seeks to evaluate if dancing can be used as training for preventing falls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 18, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

September 18, 2018

Last Update Submit

September 9, 2020

Conditions

OsteoporosisFall Injury

Outcome Measures

Primary Outcomes (1)

  • Falls

    Number of falls

    Changes from baseline at 6- and 18 months

Secondary Outcomes (8)

  • Postural stability

    Changes from baseline at 6- and 18 months

  • Pain intensity rating: McGill Pain Questionnaire

    Changes from baseline at 6- and 18 months

  • Physical Activity

    Changes from baseline at 6- and 18 months

  • Fitness assessment

    Changes from baseline at 6- and 18 months

  • Dynamical balance assessment

    Changes from baseline at 6- and 18 months

  • +3 more secondary outcomes

Study Arms (3)

Dancing group

EXPERIMENTAL

Dance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months.

Other: Training

Strength training group

ACTIVE COMPARATOR

Strength training group. Training will be administered for an hour twice a week, for six months.

Other: Training

Control

NO INTERVENTION

Control group

Interventions

TrainingOTHER

One hour of training, twice a week, for six months.

Dancing groupStrength training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray absorptiometry scanning (DXA)
  • Receiving medical treatment for osteoporosis

You may not qualify if:

  • Drug addiction defined as the use of cannabis, opioids or other drugs.
  • Use of medical cannabis.
  • Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
  • Lack of ability to cooperate.
  • Osteoporosis grade higher than moderate or severe (T-score \< -3.5)
  • Healthy elderly groups
  • T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)
  • Drug addiction defined as the use of cannabis, opioids or other drugs.
  • Use of medical cannabis.
  • Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
  • Lack of ability to cooperate.
  • Osteoporosis grade higher than mild, moderate or severe (T-score \< -2.5)
  • Receiving medical treatment for osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMI, Aalborg University

Aalborg, 9100, Denmark

RECRUITING

Related Publications (1)

  • Thomsen MJ, Liston M, Christensen MG, Vestergaard P, Hirata RP. Dancing Against falls iN Community-dwElling older adults (DANCE): a study protocol of a stratified, block-randomised trial. Inj Prev. 2022 Feb;28(1):93-101. doi: 10.1136/injuryprev-2021-044224. Epub 2021 Sep 20.

    PMID: 34544808DERIVED

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mikkel Jacobi Thomsen, PhD. stud.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikkel Jacobi Thomsen, PhD. stud.

CONTACT

4599403713mjt@hst.aau.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 25, 2018

Study Start

February 1, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)