Health Assessment in People With Severe Mental Illness
NCT07931456, Recruiting, University of the Basque Country (UPV/EHU)
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Health Assessment in People With Severe Mental Illness | ClinicalTrials.gov |
| NCT number | NCT07931456 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 275 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of the Basque Country (UPV/EHU) | ClinicalTrials.gov |
| Conditions | Severe Mental Illness, Schizophrenia, Bipolar Disorder, Depression / Major Depressive Disorder | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Peak Oxygen Uptake (VO2peak) Assessed by Cardiopulmonary Exercise Testing | Day 1 (single baseline assessment) | Cardiorespiratory fitness will be assessed by peak oxygen uptake (VO2peak), measured during a maximal cardiopulmonary exercise test (CPET) performed on a treadmill using a modified Bruce protocol. Respiratory gas exchange will be continuously measured using a calibrated gas analysis system. VO2peak will be defined as the highest oxygen uptake value obtained at the end of the exercise test and will be expressed in milliliters of oxygen per kilogram of body mass per minute (mL/kg/min). Peak effort will be evaluated using predefined physiological and perceived exertion criteria. | ClinicalTrials.gov |
| Secondary | Distance Completed in the Modified Shuttle Walk Test | Day 2 (single baseline assessment) | Functional exercise capacity will be assessed using the Modified Shuttle Walk Test (MSWT), performed over a 10-meter course with progressively increasing walking speeds. The outcome will be the total distance completed, expressed in meters (m). | ClinicalTrials.gov |
| Secondary | Body Mass Index (BMI) | Day 1 (single baseline assessment) | Body mass index will be calculated as body mass in kilograms divided by height in meters squared and expressed in kg/m². Body mass and height will be measured using standardized anthropometric procedures. | ClinicalTrials.gov |
| Secondary | Body Fat Percentage Assessed by Bioelectrical Impedance | Day 1 (single baseline assessment) | Body fat percentage will be assessed using bioelectrical impedance analysis and expressed as the percentage of total body mass consisting of fat tissue (%). | ClinicalTrials.gov |
| Secondary | Maximal Handgrip Strength | Day 1 (single baseline assessment) | Upper-body muscle strength will be assessed using a handgrip dynamometer. Participants will perform three maximal contractions with each hand. Strength will be recorded in kilograms (kg). | ClinicalTrials.gov |
| Secondary | Number of Repetitions in the 30-Second Chair Stand Test | Day 2 (single baseline assessment) | Lower-body functional strength and muscular endurance will be assessed using the 30-second Chair Stand Test. The outcome will be the number of complete sit-to-stand repetitions performed within 30 seconds. | ClinicalTrials.gov |
| Secondary | Timed Up and Go Test Completion Time | Day 2 (single baseline assessment) | Functional mobility will be assessed using the Timed Up and Go Test. The outcome will be the time required to stand from a chair, walk a standardized distance, turn, return to the chair, and sit down, expressed in seconds. | ClinicalTrials.gov |
| Secondary | Resting Systolic Blood Pressure | Day 1 (single baseline assessment) | Resting systolic blood pressure will be measured using an automated upper-arm blood pressure monitor and expressed in millimeters of mercury (mmHg). Two measurements will be obtained according to the study protocol. | ClinicalTrials.gov |
| Secondary | Resting Diastolic Blood Pressure | Day 1 (single baseline assessment) | Resting diastolic blood pressure will be measured using an automated upper-arm blood pressure monitor and expressed in millimeters of mercury (mmHg). Two measurements will be obtained according to the study protocol. | ClinicalTrials.gov |
| Secondary | Fasting Blood Glucose Concentration | Day 2 (single baseline assessment) | Fasting blood glucose concentration will be determined from a venous blood sample collected after an overnight fast. Results will be expressed in milligrams per deciliter (mg/dL) | ClinicalTrials.gov |
| Secondary | Total Cholesterol Concentration | Day 2 (single baseline assessment) | Total cholesterol concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL). | ClinicalTrials.gov |
| Secondary | Daily Physical Activity Duration Assessed by Accelerometry | Eight consecutive days following device provision | Habitual physical activity will be objectively assessed using an ActiGraph GT3X+ triaxial accelerometer worn on the nondominant wrist for eight consecutive days. The outcome will be the average daily time spent in physical activity, expressed in minutes per day. | ClinicalTrials.gov |
| Secondary | Daily Sedentary Time Assessed by Accelerometry | Eight consecutive days following device provision | Sedentary behavior will be objectively assessed using an ActiGraph GT3X+ triaxial accelerometer worn for eight consecutive days. The outcome will be the average daily time spent in sedentary behavior, expressed in minutes per day | ClinicalTrials.gov |
| Secondary | Total Sleep Time Assessed by Accelerometry | Eight consecutive days following device provision | Sleep duration will be objectively assessed using wrist-worn accelerometry over eight consecutive days. Total sleep time will be estimated using the accelerometer analysis software and expressed in minutes per night. | ClinicalTrials.gov |
| Secondary | Depressive Symptom Severity Assessed by the PHQ-9 | Day 2 (single baseline assessment) | Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity. | ClinicalTrials.gov |
| Secondary | Health-Related Quality of Life Assessed by the SF-36 | Day 2 (single baseline assessment) | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains, with domain scores transformed to a 0-100 scale, where higher scores indicate better health-related quality of life. | ClinicalTrials.gov |
| Secondary | Fat-Free Mass Assessed by Bioelectrical Impedance | Day 1 (single baseline assessment) | Fat-free mass will be assessed using bioelectrical impedance analysis. The amount of body mass excluding fat will be expressed in kilograms (kg). | ClinicalTrials.gov |
| Secondary | Waist Circumference | Day 1 (single baseline assessment) | Waist circumference will be measured using a nonelastic anthropometric tape according to standardized procedures and expressed in centimeters (cm). | ClinicalTrials.gov |
| Secondary | Waist-to-Hip Ratio | Day 1 (single baseline assessment) | Waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. Both measurements will be obtained using standardized anthropometric procedures. The outcome is dimensionless. | ClinicalTrials.gov |
| Secondary | High-Density Lipoprotein Cholesterol Concentration | Day 2 (single baseline assessment) | High-density lipoprotein cholesterol (HDL-C) concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL). | 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 0
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 |
|---|
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)