Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fall Injury, Osteoporosis

Intervention / Treatment
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* Other: Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dancing group<br>Dance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months. | Other: Training<br>* One hour of training, twice a week, for six months.<br>|
| Active Comparator: Strength training group<br>Strength training group. Training will be administered for an hour twice a week, for six months. | Other: Training<br>* One hour of training, twice a week, for six months.<br>|
| No Intervention: Control<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls | Number of falls | Changes from baseline at 6- and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural stability | Postural sway measured using a high resolution three-dimensional force platform | 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 | Changes from baseline at 6- and 18 months | 
| Physical Activity | Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire | 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. | 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. | 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. | Changes from baseline at 18 months | 
| Gait variability | Kinematic analysis of gait, recorded using the Xsens system | 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. | Changes from baseline at 6- and 18 months |