Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment
NCT03923712, Not applicable, Completed, University of Cadiz
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exercise, Brain, Cognition, OMICs, Molecular Markers and Functionality in People at Risk of Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT03923712 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 98 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Cadiz | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Alzheimer Dementia | ClinicalTrials.gov |
| Interventions | Supervised Exercise Programme | ClinicalTrials.gov |
| First posted | 2019-04-23 | ClinicalTrials.gov |
| Last updated | 2021-04-27 | ClinicalTrials.gov |
Registered outcomes 38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Assessed changes from Baseline Neuroimaging Markers of Brain Structures (thickness in mm; volumes in mm) | up to 24 weeks | Brain magnetic resonance images will be acquired in a Philips-Ingenia 3-Tesla scanner with a 32-channel digital coil exclusively dedicated to skull (Philips, The Netherlands) with the anatomical sequences: 1\. Sequence T1-3D in sagittal orientation. This sequence will quantify the cortical thickness and perform morphometric studies of cortical and subcortical structures. The pattern of cortical thickness changes and the volume of different brain structures will be obtained with the tools implemented in the software Freesurfer v5.3 and SPM12. | ClinicalTrials.gov |
| Primary | Assessed changes from Baseline Neuroimaging Markers of Brain Function (level of activity in percentage) | up to 24 weeks | Brain magnetic resonance images will be acquired in a Philips-Ingenia 3-Tesla scanner with a 32-channel digital coil exclusively dedicated to skull (Philips, The Netherlands) with the anatomical sequences: 1. DTI (Diffusion Tensor Imaging) sequence in axial orientation. This sequence will allow to evaluate the properties of the microstructure of the white matter and its nerve fiber tracts. 2. T2 / FLAIR sequences in axial orientation. Both sequences will be used to determine the degree of involvement of the deep and periventricular white matter using the Fazekas scale. | ClinicalTrials.gov |
| Primary | Assessed changes from Baseline Cognitive Status | up to 36 weeks | An overall SCORE (z-score values or similar;higher value for better outcome) of the 8 measurements on cognitive status will be developed to arrive at one reported value: 1. \- Clinical Dementia Rating -CDR: This is a valid and reliable instrument for staging dementia. 2. \- Mini Mental State Examination to detect cognitive deterioration. 3. \- Trail Making Test -TMT: This is an indicator of the speed of cognitive processing and executive functioning. 2 parts. 4. \- Boston Naming Test to assess the ability to name objects. 5. \- Clock Drawing Test -CDT: valid test for evaluation of cognitive deterioration. 6. \- Rey Auditory Verbal Learning Test -RAVLT: learning and verbal episodic memory. 7. \- The Stroop Color and Word Test -SCWT: examines basic psychological processes (cognitive flexibility, selective attention, resistance to interference from external stimuli and cognitive inhibition). 8. -Controlled Oral Word Association Test -COWAT: designed to assess verbal fluency. | ClinicalTrials.gov |
| Primary | Assessed changes from Baseline OMICs Analysis | up to 36 weeks | To carry out the analysis of the OMICs a full untargeted profiling will be carried out in the pre and post-intervention and retest measurements for different OMICS including metabolomics, proteomics,etc. For these analyzes, the following large equipment and techniques will be used, ultrahigh performance liquid chromatography / mass spectrometry (LC-quadrupole-time of flight, QTPF-MS, Agilent 1200-Agilent 6520); capillary electrophoresis / mass spectrometry (CE, TOF-MS, Agilent 7100-Agilent 6210) and gas chromatography / mass spectrometry (GC, EI-GC), mass spectrometry (capillary electrophoresis / mass spectrometry, CE-TOF-MS; Q-MS, (Quadrupolo, Agilent 7890A-Agilent 5965C) In addition, data processing platforms will be used, both mass databases and statistical tools for multivariate analysis: Mass Hunter, Mass Profiler Professional, SIMCA, MATLAB. | ClinicalTrials.gov |
| Primary | Assessed changes from Baseline Molecular Makers | up to 36 weeks | The telomere length will be measured by quantitative real-time PCR (RT-qPCR) following the method previusly described. Briefly, the DNA from the cell fraction of the blood will be extracted with the DNeasy Blood \& Tissue Kit (Qiagen) following the manufacturer's specifications. The DNA concentration of the sample, as well as its integrity, will be confirmed in a NanoDrop 2000. For the RT-qPCR the telomeric sequence will be amplified as well as a single copy gene sequence to normalize. Calibration curves will be made with serial dilutions of known concentration of both the gene sequence as well as an oligo specially designed to contain 114 copies of the TTAGGG telomeric sequence. The RT-qPCR will be carried out with 20 ng of DNA using myScript SYBR Green PCR Kit (ROCHE). The PCR conditions are: 10 min at 95 ° C, followed by 40 cycles of 95 ° C for 15 sec and 60 ° C for 1 min, followed by the corresponding dissociation curve. | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health Parameters on Functional capacity: Muscle-skeletal | up to 36 weeks | Consist in a Standardized field test battery including: 1.Muscle-skeletal (number of repetitions) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health Parameters on Functional capacity: Cardiorespiratory fitness | up to 36 weeks | Consist in a Standardized field test battery including: 2.Cardiorespiratory fitness (metres and estimated maximal oxygen uptake-VO2max) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health Parameters on Functional capacity:Agility-motor coordination | up to 36 weeks | Consist in a Standardized field test battery including: 3.Agility-motor coordination (seconds) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health Parameters on Functional capacity: Flexibility | up to 36 weeks | Consist in a Standardized field test battery including: 4.Flexibility (centimetres) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health Parameters on Functional capacity: Handgrip strength | up to 36 weeks | Consist in a Standardized field test battery including: 5.Handgrip strength (kilograms) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Incremental Exercise test: | up to 36 weeks | All subjects performed a graded exercise test on a treadmill (Lode Valiant, Groningen, Netherlands) until exhaustion. Specifically, a modified Bruce protocol previously used in a similar sample and designed for a geriatric population. Participants were asked if they had ever walking on a treadmill and instructed of the incremental test. If necessary, we familiarized them with the treadmill by walking slowly until the initial protocol speed was achieved. Before start, subjects were instructed not to talk during the test because this is known to affect the breathing and gas exchange. Participants began walking to 2.7 km/h at 0% inclination grade, every 2 minutes the speed or/and inclination were increased according the modified Bruce protocol. VO2peak was considered as the highest observed value of oxygen consumption obtained in the last three intervals of 10 seconds. | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health by the Scale of instrumental activities of the daily life of Lawton and Brody | up to 36 weeks | This scale measures the possibility of carrying out daily instrumental activities in daily life (Total score 0 to 8; higher value for better outcome). | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of hemodynamic status | up to 36 weeks | the hemodynamic status will be measured twice after 5 minutes at rest using a upper blood pressure monitor (M6 Omron): 1. -Systolic and diastolic Blood pressure (mmHg) 2. \- Resting heart rate (beats per minute) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of Body Composition: Weight | up to 36 weeks | Body Composition will be measured using a bio-impedanciometer (BIA; Tanita-MC-780MA MF 8-elc) including: 1.Weight (in kilograms) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of Body Composition:Height | up to 36 weeks | Body Composition will be measured using a Stadiometer (SECA): 2.Height (in meters) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of Body Composition: Waist Circumference | up to 36 weeks | Body Composition will be measured using an anthopometric flexible tape (SECA): 3.Waist circumference (in centimetres) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of Body Composition: Body mass index | up to 36 weeks | Body Composition will be measured as: 4.Calculated body mass index (weight and height will be combined to report BMI in kg/m\^2) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Physical Health of Body Composition: Total body fluids | up to 36 weeks | Body Composition will be measured using a bio-impedanciometer (BIA; Tanita-MC-780MA MF 8-elc) including: 5\. Total body fluids (litres). | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile: Glucose. | up to 36 weeks | The Cardio-metabolic Risk Factors Profile will be measured by several biochemical parameters including: 1.Glucose (mg/dl) | ClinicalTrials.gov |
| Secondary | Assessed changes from Baseline Blood Sample of the Cardio-metabolic Risk Factors Profile:Total cholesterol | up to 36 weeks | The Cardio-metabolic Risk Factors Profile will be measured by several biochemical parameters including: 2.Total cholesterol (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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 36653578 | DERIVED | PubMed |
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 7
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 |
|---|---|---|
| Clock Drawing Task | Primary outcome | ConductCognition |
| Picture Naming Test | 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)