임상연구정보서비스

Search: Search

Effect of Aerobic Exercise on Cognition, Emotion and Motor Coordination in patients with psychosis

Status Approved

First Submitted Date

2013/07/29
Registered Date

2013/10/02
Last Updated Date

2013/10/01

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0000873
Unique Protocol ID	연정임20130702
Public/Brief Title	Effect of Aerobic Exercise with Bike on Mental and Physical Health in Patients with Psychosis
Scientific Title	Effect of Aerobic Exercise on Cognition, Emotion and Motor Coordination in patients with psychosis
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	연정임20130702
Approval Date	2013-07-24
Institutional Review Board Name	SEVERANCE MENTAL HEALTH HOSPITAL, YONSEI UNIVERSITY COLLEGE of MEDICINE, INSTUTUTIONAL REVIEW BOARD
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Daeyoung Roh
Title	MD
Telephone
Affiliation	Severance Mental Health Hospital, Yonseity University
Address
Contact Person for Public Queries
Name	Wha-bok Lee
Title
Telephone	+82-2-897-7786
Affiliation	Gwang-Myung Community Mental Health Center
Address
Contact Person for Updating Information
Name	Daeyoung Roh
Title	MD
Telephone
Affiliation	Severance Mental Health Hospital, Yonseity University
Address

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2013-08-07 Actual
Target Number of Participant	70
Primary Completion Date	2013-12-11 , Anticipated
Study Completion Date	2013-12-31 , Anticipated
Name of Study	Severance Mental Health Hospital, Yonseity University
Recruitment Status	Recruiting
Date of First Enrollment	2013-08-07 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Severance Mental Health Hospital, Yonseity University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Severance Mental Health Hospital, Yonseity University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Schizophrenia, which is characterised by positive, negative, and cognitive symptoms, is one of the leading causes of disability among persons aged twenty to forty. Although the main treatment of schizophrenia is antipsychotic medication, patients often continue to experience positive and negative symptoms and patients with schizophrenia frequently suffer from comorbid psychiatric disorders. Exercise therapy is an established treatment for mild to moderate depression, and also in schizophrenia. In addition to a possible beneficial effect on the core symptoms and the comorbid depressive symptoms, exercise therapy is also expected to improve physical health of patients with schizophrenia. It is widely acknowledged that cycling is one of the best ways for people to achieve good health and fitness. Indeed, cycling regularly to work (and, by extension, to school and on other regular journeys) has been shown to be the most effective thing an individual can do to improve health and increase longevity. We will conduct a single blind, randomised controlled trial to examine the effects of a 4-month exercise therapy program with bike riding as compared to an active control condition namely occupational therapy, on positive, negative and comorbid depressive symptoms, need of care, and physical health in patients with schizophrenia. We hypothesise exercise therapy will improve positive, negative and depressive symptoms as well as physical health more than occupational therapy.

Study Summary Information

Lay Summary

Schizophrenia, which is characterised by positive, negative, and cognitive symptoms, is one of the leading causes of disability among persons aged twenty to forty. Although the main treatment of schizophrenia is antipsychotic medication, patients often continue to experience positive and negative symptoms and patients with schizophrenia frequently suffer from comorbid psychiatric disorders. 
  Exercise therapy is an established treatment for mild to moderate depression, and also in schizophrenia. In addition to a possible beneficial effect on the core symptoms and the comorbid depressive symptoms, exercise therapy is also expected to improve physical health of patients with schizophrenia.
It is widely acknowledged that cycling is one of the best ways for people to achieve good health and fitness. Indeed, cycling regularly to work (and, by extension, to school and on other regular journeys) has been shown to be the most effective thing an individual can do to improve health and increase longevity. 
  We will conduct a single blind, randomised controlled trial to examine the effects of a 4-month exercise therapy program with bike riding as compared to an active control condition namely occupational therapy, on positive, negative and comorbid depressive symptoms, need of care, and physical health in patients with schizophrenia. We hypothesise exercise therapy will improve positive, negative and depressive symptoms as well as physical health more than occupational therapy.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Investigator, Outcome Accessor
Allocation	RCT
Intervention Type	Behavioral
Intervention Description	Experimental group: an hour of exercise with bike riding, once every week, for 4 months Active Comarator group: an hour of occupational therapy, once every week, for 4 months
Number of Arms	2
Arm 1	Arm Label Bicycle Exercise Group
	Target Number of Participant 35
	Arm Type Experimental
	Arm Description An hour of exercise with bike riding, once every week, for 4 months. Exercise therapy will be delivered uniformly according to a strict protocol and supervised by a psychomotor therapist and monitored by nurses, social workers specialized in psychiatry. To prevent dropout of patients due to injury and exhaustion, exercise intensity will be increased gradually.
Arm 2	Arm Label Occupational Therapy Group
	Target Number of Participant 35
	Arm Type Active comparator
	Arm Description A occupational therapy will be offered by an occupational therapist 1h weekly for 4 months. Occupational therapy comprised creative and recreational activities such as painting, reading, and computer activities.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F20.9)Schizophrenia, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~65Year
	Description Schizophrenia, Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) Patients should be stable on antipsychotic medication in chronic state of the illness course.
Exclusion Criteria	1) Any evidence of significant cardiovascular, neuromuscular, endocrine, or other somatic disorders 2) Primary diagnosis of alcohol or substance abuse
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Mental status examination: Brief Psychiatric Rating Scale, Beck's Depression Inventory, State and Trait anxiety Scale
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 2
Outcome	Cardiovacular function: 6-minute walk test, step test
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 3
Outcome	Blood fasting glucose
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 4
Outcome	Trigyceride level
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Primary Outcome(s) 5
Outcome	Body weight
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Secondary Outcome(s) 1
Outcome	Self-steem scale
Timepoint	Baseline and follow-up measurements (after 4 months of intervention)+- 1 week
Secondary Outcome(s) 2
Outcome	Rotary pursuit
Timepoint	Baseline and follow-up measurements (after 4 months of intervention)+- 1 week
Secondary Outcome(s) 3
Outcome	Personal Behavioral Analysis
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Secondary Outcome(s) 4
Outcome	Relationship change Scale
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week
Secondary Outcome(s) 5
Outcome	Quality of life scale
Timepoint	Baseline and follow-up measurements (after 4 months of intervention) +- 1 week

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

Move list page Move to top