Aerobic Training Effects on Motor and Cognitive Performances in MS: an Exploratory Study With Structural and Functional MRI
NCT04097418, Not applicable, Unknown, IRCCS San Raffaele
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Aerobic Training Effects on Motor and Cognitive Performances in MS: an Exploratory Study With Structural and Functional MRI | ClinicalTrials.gov |
| NCT number | NCT04097418 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS San Raffaele | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Aerobic training compared to conventional motor training | ClinicalTrials.gov |
| First posted | 2019-09-20 | ClinicalTrials.gov |
| Last updated | 2023-09-28 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Longitudinal changes of brain GM volumes following aerobic training or conventional motor training | 2 months | Tensor-Based Morphometry will be applied on 3D T1-weighted sequence to evaluate regional GM volume changes that will be reported as t values, ranging from 0 (no statistically significant changes) to infinity (highly statistically significant changes). | ClinicalTrials.gov |
| Primary | Longitudinal changes of WM microstructural abnormalities following aerobic training or conventional motor training | 2 months | Tract-based Spatial Statistics will be applied on diffusion-tensor MRI sequence to evaluate longitudinal changes of fractional anisotropy (a dimensionless quantity ranging from 0 \[more severe damage\] to 1 \[less severe damage\]), mean diffusivity (expressed in \[(mm\^2)/s\]×10\^-3 and ranging from 0 \[less severe damage\] to infinity \[more severe damage\]), axial diffusivity (expressed in \[(mm\^2)/s\]×10\^-3 and ranging from 0 \[less severe damage\] to infinity \[more severe damage\]) and radial diffusivity (expressed in \[(mm\^2)/s\]×10\^-3 and ranging from 0 \[less severe damage\] to infinity \[more severe damage\]). Longitudinal WM microstructural changes will be reported as t values, ranging from 0 (no statistically significant changes) to infinity (highly statistically significant changes). | ClinicalTrials.gov |
| Primary | Resting State Functional Connectivity MRI changes following aerobic training or conventional motor training | 2 months | Group independent component analysis Of fMRI Toolbox (GIFT) software will be applied to evaluate the modifications of resting state functional connectivity. This will be reported as z-scores, ranging from minus infinity (reduced connectivity) to infinity (increased connectivity). Longitudinal changes in resting state functional connectivity will be obtained subtracting baseline z-score to z-score at follow-up. A positive score means increased connectivity, a negative score, a decreased connectivity. | ClinicalTrials.gov |
| Primary | Functional MRI changes following aerobic training or conventional motor training | 2 months | Statistical Parametric Mapping 12 will be applied to functional MRI sequence acquired during the Stroop task to evaluate the modifications of functional activations during this cognitive task. They will be reported as t values, ranging from 0 (no statistically significant changes) to infinity (highly statistically significant changes). | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on global clinical disability | 2 months | Rating of Expanded Disability Status Scale (EDSS) score changes: EDSS is a scale ranging from 0 (no disability) to 10 (death due to multiple sclerosis). Longitudinal changes will be obtained subtracting baseline EDSS to EDSS at follow-up. A positive score means disability worsening, a negative score, an improvement in disability. | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on clinical disability | 2 months | Rating of Multiple Sclerosis Functional Composite (MSFC) score changes: the MSFC a composite score ranging from minus infinity (worse performances) to infinity (better performances) obtained from the sum of the z-scores derived from 1) Paced Auditory Serial Addition Test (PASAT) to evaluate cognitive functions, 2) timed 25-foot walk test to evaluate walking speed, and 3) nine-hole peg test to evaluate arm and hand dexterity. Longitudinal changes will be obtained subtracting baseline MSFC to MSFC at follow-up. A positive score means disability improvement, a negative score, a worsening in disability. | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on behavioural measures | 2 months | Rating of functional Independent measurement (FIM) scale changes: the FIM scale is an 18-item of physical, psychological and social functions, ranging from 18 (worse disability) to 126 (total autonomy) and obtained from the sum of 18 items, each of them ranging from 1 to 7. Longitudinal changes will be obtained subtracting baseline FIM to FIM at follow-up. A positive score means behavioural improvements, a negative score, a worsening in behavioural functions. | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on spasticity | 2 months | Rating of Modified Ashworth Scale changes: the Modified Ashworth Scale is a 6-point scale, ranging from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement. Longitudinal changes will be obtained subtracting baseline Modified Ashworth scale to Modified Ashworth scale at follow-up. A positive score means spasticity worsening, a negative score, an improvement in spasticity. | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on walking ability | 2 months | Assessment of Six minutes walking test changes: this is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. It is expressed in meters and ranges from 0 (worse performance) to infinity (better performance). Longitudinal changes will be obtained subtracting baseline distance to distance walked at follow-up. A positive score means walking improvement, a negative score, a worsening of walking ability. | ClinicalTrials.gov |
| Primary | Effects of aerobic training compared to conventional motor training on person's mobility | 2 months | Assessment of Time up-and-go test changes: this is test assessing both static and dynamic balance. It uses the time (expressed in seconds) that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. It ranges from 0 (better performance) to infinity (worse performance). Longitudinal changes will be obtained subtracting baseline seconds to seconds needed at follow-up. A positive score means performance worsening, a negative score, an improvement in the performance. | ClinicalTrials.gov |
| Secondary | Effects of aerobic training compared to conventional motor training on cognitive functions | 2 months | Longitudinal changes of the performances at the Brief Repeatable Battery of Neuropsychological Tests and Digit Span (forward and backward): Longitudinal changes will be obtained subtracting baseline z-scores to z-scores at follow-up. A positive score means cognitive improvement, a negative score, a worsening of cognitive performance. | ClinicalTrials.gov |
| Secondary | Effects of aerobic training compared to conventional motor training on fatigue | 2 months | Assessment of Modified Fatigue Impact Scale (MFIS) changes: The MFIS score is a composite score that can range from 0 (no fatigue) to 84 (highest fatigue) and that is computed by adding sub-scores from physical, cognitive, and psychosocial subscales. Longitudinal changes will be obtained subtracting baseline MFIS to MFIS at follow-up. A positive score means fatigue worsening, a negative score, an improvement in fatigue. | ClinicalTrials.gov |
| Secondary | Effects of aerobic training compared to conventional motor training on depression | 2 months | Assessment of Beck Depression Inventory II (BDI-II) changes: the BDI-II is a 21-question multiple-choice self-report inventory ranging from 0 (no depression to 63 severe depression). The MFIS score is a composite score that can range from 0 (no fatigue) to 84 (highest fatigue) and that is computed by adding sub-scores from physical, cognitive, and psychosocial subscales. Longitudinal changes will be obtained subtracting baseline BDI-II score to BDI-II score at follow-up. A positive score means depression, a negative score, an improvement in depression. | ClinicalTrials.gov |
| Secondary | Effects of aerobic training compared to conventional motor training on quality of life | 2 months | Assessment of Multiple Sclerosis Quality of Life Scale (MSQOL-54) changes: the MSQOL-54 is a 54-item scale generated from 12 subscales and two additional single-item measures and ranging from 0 (worse quality of life) to 100 (better quality of life). Longitudinal changes will be obtained subtracting baseline MSQOL-54 to MSQOL-54 at follow-up. A positive score means quality of life improvement, a negative score, a worsening of quality of life. | 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 9
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 3
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 |
|---|---|---|
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Digit Span Test | 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)