OsteoporosisNCT03683849
Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly
A study testing Training in people with Osteoporosis and Fall Injury, run by Aalborg University at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Fall Injury
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray absorptiometry scanning (DXA)
- Receiving medical treatment for osteoporosis
- T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
SMI, Aalborg University
Aalborg, 9100
Mikkel Jacobi Thomsen, PhD fellow
About this study
Official title: Dancing as Training Method for Fall Preventing in Patients Suffering From Osteoporosis
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.
- Conditions
- Osteoporosis, Fall Injury
- Being tested
- Training
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
One hour of training, twice a week, for six months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Training |
| Strength training group | Active comparator | Strength training group. Training will be administered for an hour twice a week, for six months. Receives: Other: Training |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Number of falls
Measured: Changes from baseline at 6- and 18 months
Secondary outcomes (8)
Postural stability
Postural sway measured using a high resolution three-dimensional force platform
Measured: Changes from baseline at 6- and 18 months
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
Measured: Changes from baseline at 6- and 18 months
Physical Activity
Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire
Measured: Changes from baseline at 6- and 18 months
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.
Measured: Changes from baseline at 6- and 18 months
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.
Measured: Changes from baseline at 6- and 18 months
Bone mineral density
Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.
Measured: Changes from baseline at 18 months
Gait variability
Kinematic analysis of gait, recorded using the Xsens system
Measured: Changes from baseline at 6- and 18 months
Cognitive function
A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.
Measured: Changes from baseline at 6- and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Feb 2019
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Jacobi Thomsen, Aalborg University
- Investigators
- Mikkel Jacobi Thomsen, PhD. stud., Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683849
- Sponsor's protocol ID
- MJT.PhD.2018-2021
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dancing as Training Method for Fall Preventing in Patients Suffering From Osteoporosis
- ClinicalTrials.gov ID
- NCT03683849
- Acronym / sponsor ID
- MJT.PhD.2018-2021
- Conditions
- Osteoporosis, Fall Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dancing group | Experimental | Other: TrainingDance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months. |
| Strength training group | Active comparator | Other: TrainingStrength training group. Training will be administered for an hour twice a week, for six months. |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray absorptiometry scanning (DXA)
- Receiving medical treatment for osteoporosis
- T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingOne hour of training, twice a week, for six months. | Other | Dancing group, Strength training group |
Primary outcome
Falls
Time frame: Changes from baseline at 6- and 18 months
Number of falls
8 secondary outcomes
Postural stability
Time frame: Changes from baseline at 6- and 18 months
Pain intensity rating: McGill Pain Questionnaire
Time frame: Changes from baseline at 6- and 18 months
Physical Activity
Time frame: Changes from baseline at 6- and 18 months
Fitness assessment
Time frame: Changes from baseline at 6- and 18 months
Dynamical balance assessment
Time frame: Changes from baseline at 6- and 18 months
Bone mineral density
Time frame: Changes from baseline at 18 months
Gait variability
Time frame: Changes from baseline at 6- and 18 months
Cognitive function
Time frame: Changes from baseline at 6- and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 34544808Thomsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Jacobi Thomsen, PhD. stud. principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Osteoporosis and Fall Injury, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikkel Jacobi Thomsen, PhD. stud. (4599403713, mjt@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: Changes from baseline at 6- and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.