- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310998
Acute Psychological Effects of High Intensity Exercise With Schizophrenia
July 27, 2016 updated by: Norwegian University of Science and Technology
Acute Psychological Effects of High Intensity Exercise in Patients With Schizophrenia
The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress.
This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against.
Group 1: Patients with schizophrenia and other psychotic illnesses.
Group 2: people with non-psychotic diagnosis.
Group 3: people without any psychological diagnosis.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Trondheim, Norway, 7050
- Treningsklinikken
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- They will be allocated into groups by their diagnoses
Exclusion Criteria:
- Not being able to complete the exercise
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: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: schizophrenic disorder
|
4x4 intervals
|
|
Experimental: other psychotic disorder
|
4x4 intervals
|
|
Experimental: no mental disorder
|
4x4 intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and negative affects
Time Frame: baseline and 2 days postintervention
|
Positive and Negative Affect Schedule - Expanded Form (PANSS)
|
baseline and 2 days postintervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
state anxiety
Time Frame: baseline and 2 days postintervention
|
Questionnaire, self-report.
State anxiety inventory (SAI)
|
baseline and 2 days postintervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Einar Vedul-Kjelsås, dr.philos, Employee at AFFU at St Olavs Hospital
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.
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
December 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 11, 2011
First Submitted That Met QC Criteria
March 7, 2011
First Posted (Estimate)
March 9, 2011
Study Record Updates
Last Update Posted (Estimate)
July 28, 2016
Last Update Submitted That Met QC Criteria
July 27, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/2898-3
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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