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Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

Primary Purpose

Osteoporosis, Fall Injury

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SMI, Aalborg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Dancing group

Strength training group

Control

Arm Description

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 will be administered for an hour twice a week, for six months.

Control group

Outcomes

Primary Outcome Measures

Falls
Number of falls

Secondary Outcome Measures

Postural stability
Postural sway measured using a high resolution three-dimensional force platform
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
Physical Activity
Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire
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.
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.
Bone mineral density
Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.
Gait variability
Kinematic analysis of gait, recorded using the Xsens system
Cognitive function
A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.

Full Information

First Posted
September 18, 2018
Last Updated
September 9, 2020
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03683849
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Fall Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dancing group
Arm Type
Experimental
Arm Description
Dance intervention group, inspired by the rhythm of Salsa. Training will be administered for an hour twice a week, for six months.
Arm Title
Strength training group
Arm Type
Active Comparator
Arm Description
Strength training group. Training will be administered for an hour twice a week, for six months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Training
Intervention Description
One hour of training, twice a week, for six months.
Primary Outcome Measure Information:
Title
Falls
Description
Number of falls
Time Frame
Changes from baseline at 6- and 18 months
Secondary Outcome Measure Information:
Title
Postural stability
Description
Postural sway measured using a high resolution three-dimensional force platform
Time Frame
Changes from baseline at 6- and 18 months
Title
Pain intensity rating: McGill Pain Questionnaire
Description
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
Time Frame
Changes from baseline at 6- and 18 months
Title
Physical Activity
Description
Evaluation of physical activity using the Physical Activity Scale for Elderly (PASE) questionnaire
Time Frame
Changes from baseline at 6- and 18 months
Title
Fitness assessment
Description
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.
Time Frame
Changes from baseline at 6- and 18 months
Title
Dynamical balance assessment
Description
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.
Time Frame
Changes from baseline at 6- and 18 months
Title
Bone mineral density
Description
Bone mineral density (g/cm2) measured at spine (L1-L4) and hip, using a Hologic DXA scanner.
Time Frame
Changes from baseline at 18 months
Title
Gait variability
Description
Kinematic analysis of gait, recorded using the Xsens system
Time Frame
Changes from baseline at 6- and 18 months
Title
Cognitive function
Description
A n-back test is performed. Total number of substractions and number of mistakes made are evaluated.
Time Frame
Changes from baseline at 6- and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikkel Jacobi Thomsen, PhD. stud.
Phone
4599403713
Email
mjt@hst.aau.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Jacobi Thomsen, PhD. stud.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMI, Aalborg University
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikkel Jacobi Thomsen, PhD fellow

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34544808
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.
Results Reference
derived

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Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

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