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Trial · NCT06377254

Registered outcomes66

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

ListOutcomeTime frameDescription
PrimaryChange in Cardiorespiratory fitness (VO2 max)12 weekschange in maximal oxygen uptake (continuous incremental bicycle ergometer exercise test with on-line gas analysis) measured every 6 weeks
SecondaryChange in Isometric leg strength24 weeksChange in Isometric leg strength measured every 6 weeks using CYBEX dynamometer
SecondaryChange in time to leg fatigue24 weeksChange in time taken to induce muscle fatigue measured every 6 weeks using isokinetic knee extensions on a CYBEX dynamometer
SecondaryChange in incremental area under the curve (iAUC) for blood glucose concentration24 weeksChange in 180 minute blood glucose concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test.
SecondaryChange in iAUC for serum insulin concentration24 weeksChange in 180-minute serum insulin concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test
SecondaryChange in fasting glucose oxidation rate24 weeksChange in glucose oxidation rate (when fasted), measured every 6 weeks using ventilated hood indirect calorimetry
SecondaryChange in 'fed' glucose oxidation rate24 weeksChange in glucose oxidation rate (in the insulin-stimulated 'fed' state), measured every 6 weeks using ventilated hood indirect calorimetry during an oral glucose tolerance test
SecondaryChange in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score24 weeks
Change in 'SF36' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing measured every 6 weeks
SecondaryChange in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score24 weeks
Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better mental wellbeing, measured every 6 weeks
SecondaryChange in World Health Organisation Quality of Life (WHOQoL) score24 weeksChange in World Health Organisation Quality of Life Score (measured using the WHOQoL-Bref questionnaire every 6 weeks), (min score 0, max 100), with higher score indicating a better state of health.
SecondaryChange in Pittsburgh Sleep Quality Index (PSQI)24 weeksChange in PSQI score (min score 0, max 21), measured every 6 weeks, with higher score indicating poorer sleep quality
SecondaryChange in Stroop test; % Accuracy24 weeksChange in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%
SecondaryChange in Stroop test; reaction time24 weeksChange in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.
SecondaryChange in four-choice reaction time test; % Accuracy24 weeksChange in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%
SecondaryChange in four-choice reaction time test; reaction time24 weeksChange in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.
SecondaryChange in card sort test; % Accuracy24 weeksChange in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%
SecondaryChange in card sort test; reaction time24 weeksChange in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.
SecondaryChange in Logical reasoning test; % accuracy24 weeksChange in the accuracy of responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100%
SecondaryChange in Logical reasoning test; reaction time24 weeksChange in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined.
SecondaryChange in serial subtractions test; number of responses in 2 minutes24 weeks
Change in the number of responses, measured every 6 weeks, with higher score indicating better cognitive performance. minimum number is 0, maximum number is variable dependent on starting value (800-999; randomly selected by computer program) and speed of response.

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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