ClinicalTrials.gg
CompletedNCT03447444Updated Sep 16, 2020

Music and Physical Activity in Persons With Dementia

An interventional study of music and physical activity in Dementia Frontal, sponsored by Oslo Metropolitan University. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Nov 2014, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Motor Activity by Oslo Metropolitan University — none open to participants now, 1 under way, none of them phase 3. Motor Activity · Oslo Metropolitan University.

Enrollment
10th of 10
8 · median 113
Started
2014
the only one that year
No phase
9 of 10
none open now
Registered
7th of 10
by date

Among the 10 studies in Motor Activity by Oslo Metropolitan University, this one is the 10th largest by enrollment, is the only one that started in 2014, is one of 9 with no phase, and was the 7th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

None of the 10 studies in Motor Activity by Oslo Metropolitan University is open now.

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies in Motor Activity by Oslo Metropolitan University as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Dementia Frontal

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Keywords

  • dignity
  • music therapy
  • physical activity
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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:

-

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    music and physical activity

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

    Other: music and physical activity

Interventions

  • Othermusic and physical activity

    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.

06

What researchers measure

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

    Time frame: change from baseline to eight weeks into intervention

Secondary outcomes

  1. Neuropsychiatric Inventory

    The Neuropsychiatric Inventory-Questionnaire \[NPI-Q\] is a clinical instrument for assessing behavioral and psychological symptoms in dementia

    Time frame: baseline

07

Study locations

1 site
  • Oslo Metropolitan University
    Oslo, 0130, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2014 to primary completion in Feb 2015, 3 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 3 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Feb 27, 2018
StartActual
Nov 11, 2014
Primary completionActual
Feb 27, 2015
CompletionActual
Feb 27, 2015
Last update
Sep 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03447444
Lead sponsor
Oslo Metropolitan University
Responsible party
Dagfinn Nåden (professor, Oslo Metropolitan University) — Principal investigator
First posted
Feb 27, 2018
Start date
Nov 11, 2014
Primary completion
Feb 27, 2015
Completion
Feb 27, 2015
Last update
Sep 16, 2020

Study contacts

Dagfinn Nåden, PhD
principal investigator · Oslo Metropolitan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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