Trial · NCT07894146
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intrinsic Motivation | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Self-reported patient-reported outcome measured using the Intrinsic Motivation subscale of the Situational Motivation Scale (SIMS). It consists of four items rated on a 7-point Likert scale, ranging from 1 (does not correspond at all) to 7 (corresponds exactly). The subscale score is calculated as the mean of the four items, ranging from 1 to 7. Higher scores indicate greater intrinsic motivation and therefore a more favorable outcome. |
| Secondary | Dyspnea | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Dyspnea sensation is assessed using the Modified Borg Dyspnea Scale (Borg CR10 Scale). This patient-reported scale measures the perceived intensity of breathlessness during cycling. Scores range from 0 (no breathlessness at all) to 10 (maximal breathlessness). Higher scores indicate greater perceived dyspnea and therefore a worse outcome. |
| Secondary | Lower limb fatigue | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Lower limb fatigue is assessed using the Modified Borg Dyspnea Scale (Borg CR10 Scale). This patient-reported scale measures the perceived intensity of leg fatigue during cycling. Scores range from 0 (no fatigue at all) to 10 (maximal fatigue). Higher scores indicate greater perceived lower limb fatigue and therefore a worse outcome. |
| Secondary | Pain | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Pain perception is assessed using the Visual Analog Scale (VAS). This patient-reported scale measures the perceived intensity of pain during cycling. Scores range from 0 (no pain at all) to 10 (worst imaginable pain). Higher scores indicate greater perceived pain intensity and therefore a worse outcome. |
| Secondary | Cycle distance | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | An estimated cycle distance will be recorded during each cycling condition by the cycle ergometer in meters |
| Secondary | Identified Regulation | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Self-reported patient-reported outcome measured using the Identified Regulation subscale of the Situational Motivation Scale (SIMS). It consists of four items rated on a 7-point Likert scale, ranging from 1 (does not correspond at all) to 7 (corresponds exactly). The subscale score is calculated as the mean of the four items, ranging from 1 to 7. Higher scores indicate greater identified regulation, reflecting more autonomous motivation and therefore a more favorable outcome. |
| Secondary | External Regulation | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Self-reported patient-reported outcome measured using the External Regulation subscale of the Situational Motivation Scale (SIMS). It consists of four items rated on a 7-point Likert scale, ranging from 1 (does not correspond at all) to 7 (corresponds exactly). The subscale score is calculated as the mean of the four items, ranging from 1 to 7. Higher scores indicate greater externally controlled motivation, reflecting less autonomous motivation and therefore a less favorable outcome. |
| Secondary | Amotivation | Assessed following each cycling condition (max 20min cycling), on day 1, day 2 and day 3 | Self-reported patient-reported outcome measured using the Amotivation subscale of the Situational Motivation Scale (SIMS). It consists of four items rated on a 7-point Likert scale, ranging from 1 (does not correspond at all) to 7 (corresponds exactly). The subscale score is calculated as the mean of the four items, ranging from 1 to 7. Higher scores indicate greater amotivation and therefore a less favorable outcome. |
| Other | Heart rate during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Heart rate is monitored before, during, and immediately after each cycling condition and expressed in beats per minute (bpm) to assess physiological responses and safety. |
| Other | Respiratory rate during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Respiratory rate is monitored before, during, and immediately after each cycling condition and expressed in breaths per minute to assess respiratory responses and safety. |
| Other | Peripheral oxygen saturation during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Peripheral oxygen saturation (SpO₂) is monitored using pulse oximetry before, during, and immediately after each cycling condition and expressed as a percentage (%) to assess oxygenation and safety. |
| Other | Systolic blood pressure during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Systolic blood pressure is measured before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and safety. |
| Other | Diastolic blood pressure during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Diastolic blood pressure is measured before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and safety. |
| Other | Mean arterial pressure during cycling | Immediately before, during (up to 20 minutes), and immediately after each cycling condition. | Mean arterial pressure (MAP) is monitored before, during, and immediately after each cycling condition and expressed in millimeters of mercury (mmHg) to assess cardiovascular responses and hemodynamic safety. |
| Other | Adverse events | Assessed during and after each cycling condition | Minor/major adverse events |
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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