Health Education Programme Through Physical Exercise for People With Severe Mental Disorders
NCT06069739, Not applicable, Completed, Fundación para la Investigación del Hospital Clínico de Valencia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Health Education Programme Through Physical Exercise for People With Severe Mental Disorders | ClinicalTrials.gov |
| NCT number | NCT06069739 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 29 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fundación para la Investigación del Hospital Clínico de Valencia | ClinicalTrials.gov |
| Conditions | Severe Mental Disorder, Obesity | ClinicalTrials.gov |
| Interventions | Guided physical activity, Standard physical activity | ClinicalTrials.gov |
| First posted | 2023-10-06 | ClinicalTrials.gov |
| Last updated | 2023-10-06 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Verbal learning and memory | 4 months | Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Cognitive flexibility | 4 months | Wisconsin Card Sorting Test The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Verbal fluency | 4 months | Animal naming test for phonemic and semantic fluency. The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Working memory | 4 months | Trail Making Test The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Short-term memory | 4 months | Complutense Verbal Learning Test total immediate recall, short-term free recall and long-term free recall The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Visual memory | 4 months | Rey-Osterrieth Complex Figure Test figure two minutes after the copy and 20 minutes after the copy. The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Processing speed | 4 months | Stroop Color and Word test color/word subtest The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Functional Assessment Short Test | 4 months | Functional performance. The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Short Form-36 Health Survey questionnaire | 4 months | Quality of life. The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | World Health Organization Quality of Life brief scale | 4 months | Quality of life. The higher scores mean a better outcome. | ClinicalTrials.gov |
| Primary | Inflammatory markers | 4 months | Serum cytokine concentrations were determined using Luminex® X-MAP technology (Luminex Corp., Austin, TX, USA) based on flow cytometry. Sample processing and data analysis were performed according to the manufacturer's instructions. (Behring Nephelometer II, Dade Behring, Inc., Newark, DE, USA).. | ClinicalTrials.gov |
| Primary | Oxidative stress markers | 4 months | Oxidative stress in leukocytes was evaluated using fluorimetry techniques with a fluoroscan (Synergy MX). In total, 100 000 cells were plated in each well of 96-well plates and incubated for 30 min at 37 °C with the corresponding fluorochromes, as follows: dichlorofluorescein diacetate to measure reactive oxygen species (ROS) production (485 nm excitation, 535 nm emission), MitoSOX to measure mitochondrial ROS (mROS) (510 nm excitation, 580 nm emission), tetramethylrodamin methyl ester to assess mitochondrial membrane potential (552 nm excitation, 574 nm emission), nonylacridin orange mitochondrial mass (495 nm excitation, 519 nm emission), and 5-chloromethylfluorescein diacetate to measure intracellular glutathione (492 nm excitation, 517 nm emission). The monocyte cell line U-937 was used as an internal control to avoid potential fluctuations in fluorescence over time. | ClinicalTrials.gov |
| Primary | Adhesion molecules markers | 4 months | Serum lipid peroxidation levels were measured using a commercial thiobarbituric acid reactive substances (TBARS) kit according to the manufacturer's instructions (Olympus, Hamburg, Germany). A Luminex 200 flow analyzer system (Austin, TX, USA) was employed to analyze adhesion molecules in serum. To measure immunological markers, citrated blood samples were incubated with dextran (3%) for 45 min to isolate human polymorphonuclear leukocytes (PMNs). The supernatant was layered over Ficoll-Hypaque (GE Healthcare, Barcelona, Spain) and centrifuged for 25 min at room temperature at 650g. Lysis buffer was added to the remaining erythrocytes in the pellet, which were incubated at room temperature for 5 min and then spun at 240g for 5 min. PMNs were rinsed twice and resuspended at 37 ℃ in Hanks' balanced salt solution (Sigma Aldrich, MO). Scepter 2.0 cell counters (Millipore, MA, USA) was employed to count cells | ClinicalTrials.gov |
| Primary | Metabolic markers | 4 months | Under aseptic conditions, fasting venous blood samples were collected between 8 and 9 am to measure. | ClinicalTrials.gov |
| Primary | Maximum heart rate | 4 months | Measured with a watch-shaped device that was worn on the wrist and captured the beats per minute. | ClinicalTrials.gov |
| Primary | Systolic pressure/diastolic pressure | 4 months | Measured on the right arm using an automatic sphygmomanometer with participants in the sitting position after resting for 5 minutes. | ClinicalTrials.gov |
| Primary | Waist circumference | 4 months | Measured in the standing position at the end of normal expiration and at the midway between the inferior costal margin and the superior border of the iliac crest. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Category Fluency | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary 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)