Learning Oriented Physiotherapy - a New Approach (LOF)

January 26, 2018 updated by: Helse Nord-Trøndelag HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Aust-Agder
      • Arendal, Aust-Agder, Norway
        • Regional Psychiatric Centre Aust-Agder
    • Møre And Romsdal
      • Molde, Møre And Romsdal, Norway, 7401
        • Psychiatric Clinic
    • North Trøndelag
      • Levanger, North Trøndelag, Norway, 7601
        • Psychiatric Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The study population will be recruited among patients referred to three Norwegian psychiatric outpatient clinics for anxiety-like conditions. The same criteria for inclusion and exclusion will be applied for the experimental and active comparator group.

Inclusion Criteria:

Participants should be

  • 18 years or older
  • able to read, write and speak Norwegian
  • understand the project information and consent

Exclusion Criteria:

Participants should not

  • have ongoing substance abuse or addiction.
  • be psychotic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Learning oriented physiotherapy
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.
Behavioral: Learning Oriented Physiotherapy
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.
Other Names:
  • LOF
Active Comparator: Widely Recognized Psychiatric Treatment
Standard Outpatient Treatment within the Psychiatric clinic
Behavioral: Widely Recognized Psychiatric Treatment
Standard recognized psychiatric treatment tailored to individual needs.
Other Names:
  • CBT
  • Speech Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From baseline to 6, 12 and 18 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Levels of Anxiety and Depression
Time Frame: From baseline to 6, 12 and 18 months of follow-up

Hospital Anxiety and Depression Scale (HAD) will be used as instrument to assess levels and changes in anxiety and depression over time

.
From baseline to 6, 12 and 18 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Collaborators

Health North Trøndelag
Health Møre and Romsdal
South Coast Hospital Hf Dps Aust-Agder Units Arendal

Investigators

  • Study Director: Lars-Petter Granan, phD, Oslo University Hospital, Department of Pain Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Britt Fadnes, Kirsti Leira and Per Brodal. Learning-oriented physiotherapy. Theory and practice. University Press, 2013.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/393 (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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