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Trial · NCT07914647

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimaryAdverse events and serious adverse eventsFrom enrolment to the end of the study at 24 weeksMeasures of safety associated with the intervention
PrimaryAcceptabilityFrom enrolment to end of study at 24 weeks
Likert scale (1= none; 5 = extremely severe) rating of symptoms related to RIC via treatment logs. Less than a third of participants reporting at least moderate discomfort (mean score ≥ 3), as well as from qualitative semi-structured interviews with participants completing the study.
PrimaryComplianceFrom enrolment to end of study at 24 weeks= \> 80% intended treatment sessions completed.
SecondaryFatigue Severity ScoreFrom enrolment to end of treatment at 12 weeksMean change in FSS from baseline to end of treatment will be recorded.
SecondaryModified Fatigue Impact ScaleFrom enrolment to end of treatment at 12 weeksMFIS is a secondary measure of fatigue used to characterise fatigue symptom profiles
SecondaryBarthel IndexFrom enrolment to end of treatment at 12 weeksThe Barthel Index is a clinical assessment tool that measures a patient's level of functional independence in basic activities of daily living (ADLs) and mobility
SecondaryModified Rankin ScoreFrom enrolment to end of treatment at 12 weeksa 7-point clinical tool used to measure the degree of disability or dependence in daily activities for patients who have suffered a stroke or other neurological conditions.
SecondaryGeneralised Anxiety and Depression ScoreFrom enrolment to end of treatment at 12 weeksMeasure of Anxiety
SecondaryPhysical Health Questionnaire 9From enrolment to end of treatment at 12 weeksMeasure of Depression
SecondaryStroke Impact ScaleFrom enrolment to end of treatment at 12 weeksStroke Specific Quality of Life Measure
SecondaryEQ-5DFrom enrolment to end of treatment at 12 weeksMeasures Quality of Life
Secondary6 Minute Walk TestFrom enrolment to end of treatment at 12 weeksa clinical exercise test that measures the total distance a person can walk on a flat, hard surface over a 6-minute
SecondaryDaily Step CountFrom enrolment to end of treatment at 12 weeksMeasure of activity
SecondaryMaximal oxygen uptake (VO2 max)From enrolment to end of treatment at 12 weeksMeasure of exercise performance
SecondaryMuscle resting state ATP (MR Spectroscopy)From enrolment to end of treatment at 12 weeksto evaluate cellular energy metabolism and measure high-energy phosphates
SecondaryInterleukin 1-betaFrom enrolment to end of treatment at 12 weeksInflammatory mediator
SecondaryInterleukin 6From enrolment to end of treatment at 12 weeksInflammatory mediator
SecondaryInterleukin 10From enrolment to end of treatment at 12 weeksAnti -inflammatory mediator
SecondaryTumor Necrosis Factor AlphaFrom enrolment to end of treatment at 12 weeksInflammatory mediator

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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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