NCT03447444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

January 22, 2018

Last Update Submit

September 14, 2020

Conditions

Keywords

dignitymusic therapyphysical activity

Outcome Measures

Primary Outcomes (1)

  • 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

    change from baseline to eight weeks into intervention

Secondary Outcomes (1)

  • Neuropsychiatric Inventory

    baseline

Study Arms (1)

music and physical activity

OTHER

An intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks

Other: music and physical activity

Interventions

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.

music and physical activity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dagfinn Nåden, PhD

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: case studies
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 27, 2018

Study Start

November 11, 2014

Primary Completion

February 27, 2015

Study Completion

February 27, 2015

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations