Brain Image Markers Associated With Cognitive Training and Aerobic Exercise in Schizophrenia
NCT03509597, Not applicable, Unknown, Red Salud Mental Araba
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Brain Image Markers Associated With Cognitive Training and Aerobic Exercise in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT03509597 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Red Salud Mental Araba | ClinicalTrials.gov |
| Conditions | Schizophrenia | ClinicalTrials.gov |
| Interventions | Aerobic Exercise, Cognitive Training, Treatment as usual, Occupational Activities | ClinicalTrials.gov |
| First posted | 2018-04-26 | ClinicalTrials.gov |
| Last updated | 2019-07-30 | ClinicalTrials.gov |
Registered outcomes 41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Grey Matter Volume Change | 5 months | Assessment of Grey Matter volume changes (T1-weighted MRI) among the 3 groups using Voxel Based Morphometry (VBM). | ClinicalTrials.gov |
| Primary | Fractional Anisotropy Change | 5 months | Assessment of changes in fractional anisotropy of White Matter fibers by Diffusion Tensor MR Imaging and using the Tract-Based Spatial Statistics (TBSS). | ClinicalTrials.gov |
| Primary | Functional Magnetic Resonance Imaging (fMRI) Change at Rest | 5 months | Assessment of changes in fMRI at rest with the Coon Functional Connectivity Toolbox. | ClinicalTrials.gov |
| Primary | Functional Magnetic Resonance Imaging (fMRI) Change during the performance of a cognitive paradigm. | 5 months | Assessment of changes in fMRI during the performance of a cognitive paradigm with Statistical Parametric Mapping (SPM8). | ClinicalTrials.gov |
| Secondary | Serum BDNF | 5 months. | Assessment of changes in serum BDNF using ELISA immuno-assay techniques. Measured in ng/ml. | ClinicalTrials.gov |
| Secondary | Clinical Symptoms of Schizophrenia measured by the Positive and Negative Symptoms Scale (PANSS). | 5 months. | Severity of the negative symptoms will be assessed with the total score of the Subscale for Negative Symptoms of the PANSS scale, which comprises 7 items, each one measuring a specific negative symptom. Each item ranges from 1 (absence of the symptom) to 7 (extreme severity of the symptom). Total score of the Negative Subscale of the PANSS ranges from 7 (minimum score) to 49 (maximum severity). Severity of positive symptoms will be assessed with the total score of the Subscale for Positive Symptoms of the PANSS, which comprises 7 items ranging from 1 (absence of the symptom) to 7 (extreme severity of the symptom). Total score of the Positive Subscale ranges from 7 (minimun score) to 49 (maximun severity). General Psychopathology will be assessed with the total score of the General Psychopathology Subscale which comprises 16 items ranging from 1(absence of the symptom) to 7 (extreme severity of the symptom). | ClinicalTrials.gov |
| Secondary | Negative Symptoms of Schizophrenia measured by the Brief Negative Symptoms Scale (BNSS). | 5 months | Severity of negative symptoms will be assessed with the total score of the BNSS. Values ranges from 0 (total absence of negative symptoms) to 90 (maximum severity of negative symptoms). | ClinicalTrials.gov |
| Secondary | Negative Symptoms of Schizophrenia measured by the Clinical Assessment Interview for Negative Symptoms Scale (CAINS) | 5 months | Severity of negative symptoms will be assessed with the total score of the CAINS scale. Values ranges from 0 (total absence of negative symptoms) to 52 (maximum severity of negative symptoms). | ClinicalTrials.gov |
| Secondary | Functional Outcome measured by the UCSD Performance Based Assessment of Functional Skills in Severe Mental Illness (UPSA). | 5 months | The UPSA includes the following 5 subscales: Financial Skills, Communication, Comprehension/Planning, Transportation, Household Management. Total scores for each subscale are calculated by transforming raw scores into a 0- to-10 scale, yielding comparable scores on each scale. In order to have a 100-point summary score, each subscale score is multiplied by 2, yielding subscale scores ranging from 1 to 20. A summary UPSA score is calculated by summing these five scores, resulting in total scores ranging from 0 to 100. Scores of 0 represent maximum severity of functional impairment and a score of 100 represents total absence of functional disability. | ClinicalTrials.gov |
| Secondary | Functional Outcome measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0). | 5 months | The 36-item version of WHODAS 2.0 allows users to generate scores for the six domains of functioning and to calculate an overall functioning score. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "se- vere" (4) and "extreme" (5) - are summed. A score of 36 represents total absence of disability and 180 maximum severity of disability. | ClinicalTrials.gov |
| Secondary | Functional Outcome measured by the Short Form (36) Health Survey (SF-36). | 5 months | The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | ClinicalTrials.gov |
| Secondary | Physical Condition measured by the Modified Shuttle Walking Test | 5 months | Heart rate achieved when walking between 2 cones spaced 10 meters at an increasing rate. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory Fitness measured with the Peak Oxygen Uptake (VO2 max) | 5 months | maximum rate of oxygen consumption measured during incremental exercise (exercise of increasing intensity) | ClinicalTrials.gov |
| Secondary | Weight. | 5 months | Weight in Kg | ClinicalTrials.gov |
| Secondary | Height | 5 months | Height in meters. | ClinicalTrials.gov |
| Secondary | Body composition measured with Body Mass Index (BMI) | 5 months. | The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | ClinicalTrials.gov |
| Secondary | Abdominal Perimeter | 5 months | Abdominal perimeter measured in centimeters. | ClinicalTrials.gov |
| Secondary | Body Composition measured with Total Body Water. | 5 months | Percentage of Total Body Water measured by Bioimpedance. | ClinicalTrials.gov |
| Secondary | Body Composition measured with Body Fat. | 5 months | Percentage of Body Fat measured by Bioimpedance. | ClinicalTrials.gov |
| Secondary | Blood Pressure (systolic and diastolic) | 5 months | Blood Pressure (systolic and diastolic) measured in millimeters of mercury (mmHg) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Alternative Uses Task | Secondary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Emoji Emotion Recognition | Secondary outcome | ConductCognition |
| Mental State Stories Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)