UMIN-CTR Clinical Trial

Basic information
Public title	Aerobic exercise versus cognitive remediation versus a combination of both in patients with schizophrenia: a three-arm, randomized controlled pilot and feasibility study
Acronym	Aerobic exercise versus cognitive remediation versus a combination of both in patients with schizophrenia: a three-arm, randomized controlled pilot and feasibility study
Scientific Title	Aerobic exercise versus cognitive remediation versus a combination of both in patients with schizophrenia: a three-arm, randomized controlled pilot and feasibility study
Scientific Title:Acronym	Aerobic exercise versus cognitive remediation versus a combination of both in patients with schizophrenia: a three-arm, randomized controlled pilot and feasibility study
Region	Japan

Condition
Condition	schizophrenia
Classification by specialty	Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate aerobic exercise versus cognitive remediation versus a combination of both in patients with schizophrenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognition
Key secondary outcomes	Intrinsic motivation Psychiatric symptom Functioning

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Aerobic exercise
Interventions/Control_2	cognitive remediation
Interventions/Control_3	a combination of both
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1) 20-60 years of age (2) diagnosed with schizophrenia based on DSM 5
Key exclusion criteria	(1) a current primary DSM 5 diagnosis other than schizophrenia (2) a history of mental retardation (3) a history of neurological disorder (4) a history of significant drug or alcohol abuse (5) current risk of suicide, or a history of suicidal behavior within 6 months prior to consent (6) comorbid serious physical disorder
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Shimada
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	386-0401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268350305
Email	ot@seitaikai.or.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Shimada
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Division name	Department of Rehabilitation
Zip code	386-0401
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
TEL	0268-35-0305
Homepage URL
Email	ot@seitaikai.or.jp

Sponsor
Institute	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Institute
Department

Funding Source
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Corporation Seitaikai Mental Support Soyokaze Hospital
Address	3057-1, Shiogawa, Ueda, Nagano, Japan
Tel	0268-35-0305
Email	ot@seitaikai.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2022 Year 04 Month 15 Day
Date of IRB	2022 Year 04 Month 15 Day
Anticipated trial start date	2022 Year 04 Month 15 Day
Last follow-up date	2022 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 14 Day
Last modified on	2022 Year 10 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054151