AgitationLOFNCT02194036
Learning Oriented Physiotherapy - a New Approach
A study testing Learning Oriented Physiotherapy and Widely Recognized Psychiatric Treatment in people with Agitation and Anxiety, run by Helse Nord-Trøndelag HF at 3 sites in Norway.
Trial summary
Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Learning Oriented Physiotherapy and Widely Recognized Psychiatric Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 3 sitesNorway
- Study dates
- Aug 2014to 1 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants should be
- 18 years or older
- able to read, write and speak Norwegian
- understand the project information and consent
Who cannot join
- Participants should not
- have ongoing substance abuse or addiction.
- be psychotic.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Regional Psychiatric Centre Aust-Agder
Arendal, Aust-Agder
Psychiatric Clinic
Levanger, North Trøndelag, 7601
Psychiatric Clinic
Molde, Møre and Romsdal, 7401
About this study
Official title: The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders
Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints.
This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.
- Being tested
- Learning Oriented Physiotherapy, Widely Recognized Psychiatric Treatment
- Keywords
- Ownership of body, Bodily and mental balance, Learning, Body image, Sensations, Expectations
- Medical subject headings
- Psychomotor Agitation, Anxiety Disorders, Dizziness, Pain, Hypesthesia, Depression, Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Oriented PhysiotherapyBehavioural
Also called LOF
Clinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior.
Widely Recognized Psychiatric TreatmentBehavioural
Also called CBT, Speech Therapy
Standard recognized psychiatric treatment tailored to individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Learning oriented physiotherapy | Experimental | Learning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs. Receives: Behavioral: Learning Oriented Physiotherapy |
| Widely Recognized Psychiatric Treatment | Active comparator | Standard Outpatient Treatment within the Psychiatric clinic Receives: Behavioral: Widely Recognized Psychiatric Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Health Related Quality of Life (HRoQL)
In this study HRoQL will be measured by the validated EQ5D questionnaire
Measured: From baseline to 6, 12 and 18 months of follow-up
Secondary outcomes (1)
Changes in Levels of Anxiety and Depression
Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time
.
Measured: From baseline to 6, 12 and 18 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startAug 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Health North Trøndelag, Health Møre and Romsdal, South Coast Hospital Hf Dps Aust-Agder Units Arendal
- Responsible party
- Sponsor
- Investigators
- Lars-Petter Granan, phD, Study director, Oslo University Hospital, Department of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194036
- Sponsor's protocol ID
- 2014/393 (REK)
- Acronym
- LOF
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Learning Oriented Physiotherapy on Health-Related Functioning and Quality of Life in Patients With Various Anxiety Disorders
- ClinicalTrials.gov ID
- NCT02194036
- Acronym / sponsor ID
- LOF / 2014/393 (REK)
- Keywords
- Ownership of body, Bodily and mental balance, Learning, Body image, Sensations, Expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Health North Trøndelag, Health Møre and Romsdal, South Coast Hospital Hf Dps Aust-Agder Units Arendal
- Study start
- Aug 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 18 Jul 2014 (estimated)
- 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.
Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints.
This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Learning oriented physiotherapy | Experimental | Behavioral: Learning Oriented PhysiotherapyLearning oriented physiotherapy is a treatment approach based on knowledge from neuroscience and particularly aimed to curb physical symptoms and ailments, but also to regain a sense of better physical balance and mental control. Therapy sessions are normally given every 2 weeks with individual homework lessons between. The therapy will last between 6 to 12 months depending on learning process and individual needs. |
| Widely Recognized Psychiatric Treatment | Active comparator | Behavioral: Widely Recognized Psychiatric TreatmentStandard Outpatient Treatment within the Psychiatric clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants should be
- 18 years or older
- able to read, write and speak Norwegian
- understand the project information and consent
Key exclusion criteria (3 listed)
- Participants should not
- have ongoing substance abuse or addiction.
- be psychotic.
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 |
|---|---|---|
| Learning Oriented PhysiotherapyAlso: LOFClinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior. | Behavioural | Learning oriented physiotherapy |
| Widely Recognized Psychiatric TreatmentAlso: CBT, Speech TherapyStandard recognized psychiatric treatment tailored to individual needs. | Behavioural | Widely Recognized Psychiatric Treatment |
Primary outcome
Changes in Health Related Quality of Life (HRoQL)
Time frame: From baseline to 6, 12 and 18 months of follow-up
In this study HRoQL will be measured by the validated EQ5D questionnaire
1 secondary outcome
Changes in Levels of Anxiety and Depression
Time frame: From baseline to 6, 12 and 18 months of follow-up
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 30 Jan 2018.
- BackgroundBritt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.
- A website with information about the learning-oriented therapy as a new approach, based on new knowledge in neuroscienceLink provided by the sponsor.
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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.
Lars-Petter Granan, phD study director
Oslo University Hospital, Department of Pain Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning Oriented Physiotherapy and Widely Recognized Psychiatric Treatment in people with Agitation and Anxiety, run by Helse Nord-Trøndelag HF at 3 sites 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 4 inclusion and 3 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Changes in Health Related Quality of Life (HRoQL) (time frame: From baseline to 6, 12 and 18 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02194036, which also lists 1 linked publication.
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 30 Jan 2018.