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Trial · NCT07740967

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryJoint pain under 3 conditions as measured by a 100 mm visual analogue scale (VAS)8 weeks
Participants will place a vertical line on the VAS (ranging from no pain (0 mm) to unbearable pain (100 mm)) which will be measured and recorded. Participants will complete a separate VAS for each of the 3 conditions: after standing rest, after 5 body weight squats, and in response to pain levels during daily activities in the last week (such as walking, getting up from chairs, exercising).
SecondaryHand grip strength dynamometry (kg)8 weeksHand grip strength will be assessed following the Southampton Protocol, where 3 measures will be taken for each hand.
SecondaryBlood pressure (mmHg)8 weeksAfter 10 minutes of seated rest, 3 blood pressure readings will be taken and recorded using an automated cuff.
SecondaryFatigue under 2 conditions measured by a 100 mm visual analogue scale (VAS)8 weeks
Participants will place a vertical line on the scale (ranging from no fatigue at all (0 mm) to extremely fatigued (100 mm)) which will be measured and recorded. Participants will complete a visual analogue scale for 2 conditions: right now, and during daily activities in the last week (such as walking, getting up from chairs, exercising).
SecondarySleep quality measured by an Athens Insomnia Scale8 weeks
The Athens Insomnia Scale is an 8-point questionnaire where participants rank different aspects of their sleep (sleep induction, awakenings during the night, final awakening, total sleep duration, overall sleep quality, sense of wellbeing during the day, functioning during the day, and sleepiness during the day) provided that it occurred at least 3 times in the last week from 0 (no issue) to 3 (serious issue). A lower total score indicates better sleep.
SecondarySimple Sleep Quality Scale8 weeks
The simple Sleep Quality Scale asks the following question 'During the past 7 days, how would you rate your sleep quality overall?'. Participants select a number from 0 (terrible) to 10 (excellent). A lower score indicates better sleep.
SecondaryAortic Augmentation (AP, mmHg)8 weeksMeasured using radial artery tonometry
SecondaryAortic Augmentation Index (AP/PP, %)8 weeksMeasured using radial artery tonometry
SecondaryLetter Comparison test of cognitive function8 weeksMeasuring reaction time (ms) and accuracy (%)
SecondaryBackwards Digit Span test of cognitive function8 weeksMeasuring the longest correct span score (higher score = better working memory)
SecondaryStroop Colour Word test of cognitive function8 weeksMeasuring congruent/incongruent/neutral reaction time (ms)
SecondaryStroop Colour Word test of cognitive function8 weeksMeasuring the Interference Effect (calculated as incongruent reaction time - congruent reaction time)
SecondaryQuality of life assessed by the 36-Item Short Form Survey Instrument (SF-36)8 weeksA total score is calculated as a percentage
SecondaryGastrointestinal (GI) Comfort measured via a Likert Scale under 3 conditions8 weeks
Participants select one option on the Likert scale ranging from 1 (no GI discomfort) to 4 (lots/frequent/extreme GI discomfort). There is a Likert Scale for each of the following conditions: GI discomfort right now, GI discomfort frequency in the last 8 weeks, and GI discomfort severity in the last 8 weeks.
SecondaryMenstrual cycle/menopause symptom questionnaire8 weeks
The questionnaire assesses 12 common menstrual cycle/menopause symptoms. Participants rate the severity (0 = none, to 3 = severe) and frequency (0 = never, to 3 = often) of these symptoms. A higher score indicates worse menstrual cycle/menopause symptoms
SecondaryFatty acid blood profile8 weeks
SecondaryBody mass (kg)8 weeks
SecondaryFat mass (kg)8 weeksMeasured in kilograms and as a fat percentage (%)
SecondaryFat free mass (kg)8 weeks
SecondarySkeletal muscle mass (kg)8 weeks

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

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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