Back to resultsMusic and Physical Activity in Persons With Dementia
Primary Purpose
Dementia Frontal
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
music and physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia Frontal focused on measuring dignity, music therapy, physical activity
Eligibility Criteria
Inclusion Criteria:Persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home
-
Exclusion Criteria:
-
Sites / Locations
- Oslo Metropolitan University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
music and physical activity
Arm Description
An intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks
Outcomes
Primary Outcome Measures
Brøset Violence Checklist
The BVC assesses the presence of six observable patient behaviors, namely whether the patient is confused, irritable, boisterous, verbally threatening, physically threatening, and/or attacking objects
Secondary Outcome Measures
Neuropsychiatric Inventory
The Neuropsychiatric Inventory-Questionnaire [NPI-Q] is a clinical instrument for assessing behavioral and psychological symptoms in dementia
Full Information
NCT ID
NCT03447444
First Posted
January 22, 2018
Last Updated
September 14, 2020
Sponsor
Oslo Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT03447444
Brief Title
Music and Physical Activity in Persons With Dementia
Official Title
Dignity for Persons With Dementia and Signs of Frontotemporal Affection in Institutions.See us and Dance With us
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (Actual)
Primary Completion Date
February 27, 2015 (Actual)
Study Completion Date
February 27, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fronto lobe dementia constitutes 10-20 % of dementia conditions within younger persons (>65). People with neuronal degeneration in frontal and temporal lobes demonstrate a decline in social conduct, apathy, loss of insight that is gradual and progressive. Family members often experience guilt and shame because of the patients' behavior before institutionalization, and different behavioral disorders will cause great challenges to family caregivers and to staff after institutionalization. Preservation of dignity, both in regards to the person being affected, and their relatives, therefore seem highly relevant both before and after institutionalization.
Detailed Description
The purpose of this study was to evaluate whether a combined intervention of physical activity and music therapy could reduce restlessness, irritability, and aggression among institutionalized people with severe dementia. An exploratory design was used to evaluate a combined intervention of physical activity, music therapy, and in- or outdoors walking daily, systematically implemented for eight weeks for persons with severe dementia in institutional care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Frontal
Keywords
dignity, music therapy, physical activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case studies
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music and physical activity
Arm Type
Other
Arm Description
An intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks
Intervention Type
Other
Intervention Name(s)
music and physical activity
Intervention Description
This feasibility study focus on promoting a combination of music therapy and physical activity with the primary goal to describe the influence on restlessness, irritability, and aggression in persons with severe stage of dementia with a mixture of symptoms including frontal lobe problems in institutional care. A secondary goal is to investigate the treatment fidelity.
Primary Outcome Measure Information:
Title
Brøset Violence Checklist
Description
The BVC assesses the presence of six observable patient behaviors, namely whether the patient is confused, irritable, boisterous, verbally threatening, physically threatening, and/or attacking objects
Time Frame
change from baseline to eight weeks into intervention
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory
Description
The Neuropsychiatric Inventory-Questionnaire [NPI-Q] is a clinical instrument for assessing behavioral and psychological symptoms in dementia
Time Frame
baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Persons with dementia with symptoms of frontal lobe dementia, who had lived for at least 6 months in a unit special care dementia unit in a nursing home
-
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagfinn Nåden, PhD
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo Metropolitan University
City
Oslo
ZIP/Postal Code
0130
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Music and Physical Activity in Persons With Dementia
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