NCT01310998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

January 11, 2011

Last Update Submit

July 27, 2016

Conditions

Schizophrenia

Keywords

Schizophreniahigh intensity exerciseinterval training exercise

Outcome Measures

Primary Outcomes (1)

  • Positive and negative affects

    Positive and Negative Affect Schedule - Expanded Form (PANSS)

    baseline and 2 days postintervention

Secondary Outcomes (1)

  • state anxiety

    baseline and 2 days postintervention

Study Arms (3)

schizophrenic disorder

EXPERIMENTAL
Behavioral: High intensity exercise

other psychotic disorder

EXPERIMENTAL
Behavioral: High intensity exercise

no mental disorder

EXPERIMENTAL
Behavioral: High intensity exercise

Interventions

High intensity exerciseBEHAVIORAL

4x4 intervals

no mental disorderother psychotic disorderschizophrenic disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • They will be allocated into groups by their diagnoses

You may not qualify if:

  • Not being able to complete the exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treningsklinikken

Trondheim, 7050, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25400592RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Einar Vedul-Kjelsås, dr.philos

    Employee at AFFU at St Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

March 9, 2011

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

NO(1)