Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

Osteoporosis Clinical Trial

Official title:

Dancing as Training Method for Fall Preventing in Patients Suffering From Osteoporosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683849
• Other study ID #: MJT.PhD.2018-2021
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2020
• Source: Aalborg University
• Contact: Mikkel Jacobi Thomsen, PhD. stud.
• Phone: 4599403713
• Email: mjt[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall Injury
• Osteoporosis

Intervention

Other:
• Training
One hour of training, twice a week, for six months.

Locations

Country	Name	City	State
Denmark	SMI, Aalborg University	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Number of falls	Changes from baseline at 6- and 18 months
Secondary	Postural stability	Postural sway measured using a high resolution three-dimensional force platform	Changes from baseline at 6- and 18 months
Secondary	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	Changes from baseline at 6- and 18 months
Secondary	Physical Activity	Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire	Changes from baseline at 6- and 18 months
Secondary	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.	Changes from baseline at 6- and 18 months
Secondary	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.	Changes from baseline at 6- and 18 months
Secondary	Bone mineral density	Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.	Changes from baseline at 18 months
Secondary	Gait variability	Kinematic analysis of gait, recorded using the Xsens system	Changes from baseline at 6- and 18 months
Secondary	Cognitive function	A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.	Changes from baseline at 6- and 18 months