Acute Psychological Effects of High Intensity Exercise Wi... | NCT01310998

Studies
Acute Psychological Effects of High Intensity Exercise With Schizophrenia

NCT01310998

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

High intensity exercise

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 11, 2011

First Submission Date that Met QC Criteria

Mar 7, 2011

First Posted Date

Mar 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
schizophrenic disorder	Experimental	Behavioral: High intensity exercise
other psychotic disorder	Experimental	Behavioral: High intensity exercise
no mental disorder	Experimental	Behavioral: High intensity exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High intensity exercise	Behavioral	4x4 intervals	no mental disorder other psychotic disorder schizophrenic disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive and negative affects	Positive and Negative Affect Schedule - Expanded Form (PANSS)	baseline and 2 days postintervention

Secondary Outcomes

Measure	Description	Time Frame
state anxiety	Questionnaire, self-report. State anxiety inventory (SAI)	baseline and 2 days postintervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

They will be allocated into groups by their diagnoses

Exclusion Criteria:

Not being able to complete the exercise

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Einar Vedul-Kjelsås, dr.philos	Employee at AFFU at St Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Treningsklinikken		Trondheim		7050	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25400592	Result	Heggelund J, Kleppe KD, Morken G, Vedul-Kjelsas E. High aerobic intensity training and psychological States in patients with depression or schizophrenia. Front Psychiatry. 2014 Oct 30;5:148. doi: 10.3389/fpsyt.2014.00148. eCollection 2014.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement