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Trial · NCT05967052

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score3 months and 6 monthsChange in fatigue intensity expressed as a difference in Multidimensional Fatigue Inventory-20 (MFI-20) score at 3 and 6 months of the study relative to the baseline score
PrimaryWalking distance as a difference in score from the 6 Minute Walking Test3 months and 6 monthsWalking distance as a difference in score from the 6 Minute Walking Test at 3 and 6 months compared to baseline
SecondaryChange in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński)3 months and 6 months
Change in the level of satisfaction with life expressed in the form of the result of the Satisfaction with Life Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of the study
SecondaryChange in the result obtained in the "Beck Depression Inventory (BDIII)" study3 months and 6 monthsChange in the result obtained in the "Beck Depression Inventory (BDIII)" study in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.
SecondaryChange in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI)3 months and 6 monthsChange in the result obtained in the anxiety test - State and Trait Anxiety Inventory (STAI) in the 3rd and 6th month of the study in relation to the result on the day of the study commencement.
SecondaryChange in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) i3 months and 6 months
Change in the degree of acceptance of the disease assessed by the Acceptance of Illness Scale (Juczyński) in the 3rd and 6th month of the study in relation to the result on the day of starting the study
SecondaryChange in the result of the CCT test3 months and 6 monthsChange in the result of the CCT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.
SecondaryChange in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST)3 months and 6 months
Change in neuropsychological assessment expressed by the change in the result of the Wisconsin Card Sorting Test (WCST) in the 3rd and 6th month of the study compared to the result on the day of the study commencement.
SecondaryChange in the result of the RFFT test3 months and 6 monthsChange in the result of the RFFT test in the 3rd and 6th month of the study compared to the result on the day of starting the study.
SecondaryChange in the WAIS-R intelligence test result3 months and 6 monthsChange in the WAIS-R intelligence test result in the 3rd and 6th month of the study in relation to the result on the day of the study commencement
SecondaryChange in reaction time expressed by the Stroop interference test3 months and 6 monthsChange in reaction time expressed by the Stroop interference test in the 3rd and 6th month of the study compared to the result on the day of the study start.
SecondaryChange in the assessment of the quality of gait3 months and 6 monthsChange in the assessment of the quality of gait in the 3rd and 6th month of the study in relation to the result on the day of the beginning of the study
SecondaryChange in walking speed3 months and 6 monthsChange in walking speed in the 3rd and 6th month of the study in relation to the result on the day of the study.
OtherThe change in the profile of the examined inflammatory cytokines3 months and 6 monthsThe exploratory endpoint is the change in the profile of the examined inflammatory cytokines in the 3rd and 6th month of the study in relation to the result before the start of the study.
OtherNumber of adverse events and the number and percentage of patients who experienced adverse events3 months and 6 monthsNumber of adverse events and the number and percentage of patient who experienced adverse events
OtherNumber of adverse events and the number and proportion of patients who experienced treatment-related adverse events3 months and 6 monthsNumber of adverse events and the number and proportion of patients who experienced treatment-related adverse events
OtherNumber of serious adverse events and number and proportion of patients with serious adverse events.3 months and 6 monthsNumber of serious adverse events and number and proportion of patients with serious adverse events.
OtherNumber of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.3 months and 6 monthsNumber of serious adverse events and the number and proportion of patients who experienced treatment-related serious adverse events.
OtherNumber and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.3 months and 6 monthsNumber and percentage of patients who discontinued participation in the study due to an adverse event - changes in laboratory parameters and basic vital signs.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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