Clinical trial NCT03683849: Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly
Official title: Dancing as Training Method for Fall Preventing in Patients Suffering From Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Fall Injury
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Falls
timeFrame: Changes from baseline at 6- and 18 months
Secondary outcomes:
measure: Postural stability
timeFrame: Changes from baseline at 6- and 18 months
measure: Pain intensity rating: McGill Pain Questionnaire
timeFrame: Changes from baseline at 6- and 18 months
measure: Physical Activity
timeFrame: Changes from baseline at 6- and 18 months
measure: Fitness assessment
timeFrame: Changes from baseline at 6- and 18 months
measure: Dynamical balance assessment
timeFrame: Changes from baseline at 6- and 18 months
measure: Bone mineral density
timeFrame: Changes from baseline at 18 months
measure: Gait variability
timeFrame: Changes from baseline at 6- and 18 months
measure: Cognitive function
timeFrame: Changes from baseline at 6- and 18 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: SMI, Aalborg University
Study officials:
affiliation: Aalborg University
name: Mikkel Jacobi Thomsen, PhD. stud.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.