Dementia FrontalNCT03447444
Music and Physical Activity in Persons With Dementia
A study testing music and physical activity in people with Dementia Frontal, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia Frontal
- What is being tested?
- music and physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorway
- Study dates
- 11 Nov 2014to 27 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dignity for Persons With Dementia and Signs of Frontotemporal Affection in Institutions.See us and Dance With us
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.
- Conditions
- Dementia Frontal
- Being tested
- music and physical activity
- Keywords
- dignity, music therapy, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music and physical activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| music and physical activity | Other | An intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks Receives: Other: music and physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start11 Nov 2014
- Primary completion27 Feb 2015
- Study completion27 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia FrontalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- case studies
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dagfinn Nåden, Oslo Metropolitan University
- Investigators
- Dagfinn Nåden, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447444
- Sponsor's protocol ID
- Frontallob dementia
- Status last verified
- Sep 2020
- First submitted
- 22 Jan 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dignity for Persons With Dementia and Signs of Frontotemporal Affection in Institutions.See us and Dance With us
- ClinicalTrials.gov ID
- NCT03447444
- Acronym / sponsor ID
- Frontallob dementia
- Conditions
- Dementia Frontal
- Keywords
- dignity, music therapy, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 11 Nov 2014 (actual)
- Primary completion
- 27 Feb 2015 (actual)
- Study completion
- 27 Feb 2015 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- case studies
| Arm | Type | Receives |
|---|---|---|
| music and physical activity | Other | Other: music and physical activityAn intervention consisting of physical activity, music and walking, was systematically implemented for eight weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music and physical activityThis 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. | Other | music and physical activity |
Primary outcome
Brøset Violence Checklist
Time frame: change from baseline to eight weeks into intervention
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
1 secondary outcome
Neuropsychiatric Inventory
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dagfinn Nåden, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music and physical activity in people with Dementia Frontal, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brøset Violence Checklist (time frame: change from baseline to eight weeks into intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.