Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

Not Applicable

• Conditions: Fall Injury; Osteoporosis
• Interventions: Other: Training

• Registration Number: NCT03683849
• Lead Sponsor: Aalborg University

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.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2019-02-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dancing group	Training	Dance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months.
Strength training group	Training	Strength training group. Training will be administered for an hour twice a week, for six months.

Primary Outcome Measures

Name	Time	Method
Falls	Changes from baseline at 6- and 18 months	Number of falls

Secondary Outcome Measures

Name	Time	Method
Postural stability	Changes from baseline at 6- and 18 months	Postural sway measured using a high resolution three-dimensional force platform
Fitness assessment	Changes from baseline at 6- and 18 months	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.
Dynamical balance assessment	Changes from baseline at 6- and 18 months	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.
Gait variability	Changes from baseline at 6- and 18 months	Kinematic analysis of gait, recorded using the Xsens system
Pain intensity rating: McGill Pain Questionnaire	Changes from baseline at 6- and 18 months	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
Physical Activity	Changes from baseline at 6- and 18 months	Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire
Bone mineral density	Changes from baseline at 18 months	Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.
Cognitive function	Changes from baseline at 6- and 18 months	A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.

Trial Locations

Locations (1)

SMI, Aalborg University; 🇩🇰 Aalborg, Denmark