CClinicalTrials.gg
Status unknownNCT03683849Updated Sep 10, 2020

Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

An interventional study of Training in Osteoporosis and Fall Injury, sponsored by Aalborg University. Status unknown at 1 site in Denmark. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by Aalborg University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed description

This study seeks to examine the relationship between strength, postural control and bone mineral density on the risk of falling among elderly (65 yr or older). The study will carried out on osteoporosis patients and healthy, matched controls. The study further seeks to examine whether a dancing intervention may improve any of these parameters, resulting in a decreased risk of falling.

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Conditions studied

  • Osteoporosis
  • Fall Injury

Browse trials for

03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 180 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Patient groups

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Dancing group

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

    Other: Training

  • Active comparator
    Strength training group

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

    Other: Training

  • No intervention
    Control

    Control group

Interventions

  • OtherTraining

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

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What researchers measure

Primary outcomes

  1. Falls

    Number of falls

    Time frame: Changes from baseline at 6- and 18 months

Secondary outcomes

  1. Postural stability

    Postural sway measured using a high resolution three-dimensional force platform

    Time frame: Changes from baseline at 6- and 18 months

  2. Pain intensity rating: McGill Pain Questionnaire

    Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable), indicating pain areas on a body chart and filling out a McGill Pain Questionnaire

    Time frame: Changes from baseline at 6- and 18 months

  3. Physical Activity

    Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire

    Time frame: Changes from baseline at 6- and 18 months

  4. Fitness assessment

    Evaluation of fitness using the Fullerton Functional Fitness Assessment. The test is a 6-item test. The score in each of the six tests is assessed separately and will not be used to provide a total score of the six tests.

    Time frame: Changes from baseline at 6- and 18 months

  5. Dynamical balance assessment

    Evaluation of the dynamical balance using the Mini-Balance Evaluation Systems Test (Mini-BESTest), which is a 14-item test, scored on a 3-level ordinal scale. The scale ranges from 0-28, with a higher score representing better dynamical balance.

    Time frame: Changes from baseline at 6- and 18 months

  6. Bone mineral density

    Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.

    Time frame: Changes from baseline at 18 months

  7. Gait variability

    Kinematic analysis of gait, recorded using the Xsens system

    Time frame: Changes from baseline at 6- and 18 months

  8. Cognitive function

    A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.

    Time frame: Changes from baseline at 6- and 18 months

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Study locations

1 of 1 sites recruiting
  • SMI, Aalborg University
    Aalborg, 9100, Denmark
    • Mikkel Jacobi Thomsen, PhD fellow · Contact
    Recruiting
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References and documents

Publications

  • 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. PubMed 34544808 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03683849
Lead sponsor
Aalborg University
Responsible party
Mikkel Jacobi Thomsen (Principal Investigator, Aalborg University) — Principal investigator
First posted
Sep 25, 2018
Start date
Feb 1, 2019
Primary completion
Aug 30, 2021 (estimated)
Completion
Aug 30, 2021 (estimated)
Last update
Sep 10, 2020

Study contacts

Mikkel Jacobi Thomsen, PhD. stud.
Contact
mjt@hst.aau.dk
4599403713
Mikkel Jacobi Thomsen, PhD. stud.
principal investigator · Aalborg University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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