Trial · NCT07625371
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Participants Reaching Each Recruitment and Participation Milestone | From screening through the fifth laboratory visit, up to 6 weeks per participant | Recruitment and participant flow were summarized as the number and percentage of individuals who were screened, preliminarily eligible, ineligible, individually contacted or offered participation, not contacted because recruitment ended, nonresponsive, declined, consented and completed the baseline/familiarization visit, withdrew before randomization, randomized, and completed all experimental visits. |
| Primary | Number and Percentage of Randomized Participants Who Completed All Experimental Visits | From randomization after the baseline/familiarization visit through the fifth laboratory visit, an average of 32 days | Post-randomization retention was summarized as the number and percentage of randomized participants who completed all four experimental visits. Reasons for post-randomization withdrawal or noncompletion were documented when available. |
| Primary | Number and Percentage of Planned Experimental Sessions Completed | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Experimental session completion was summarized as the number and percentage of planned experimental sessions that were started and the number and percentage of started sessions in which participants completed the full 25-minute treadmill bout. Session completion was summarized overall and by condition. |
| Primary | Number of Participants With Safety Events During Experimental Treadmill Sessions | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Safety was summarized as the number of participants with documented adverse events, near-falls, safety-harness events, participant requests to stop, early stops due to dizziness, pain, unusual shortness of breath, discomfort, loss of balance, unsafe positioning, equipment malfunction, or staff judgment that continuing would be unsafe. |
| Primary | Mean Feeling Scale Score During Each Treadmill Exercise Phase | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Emotional feeling was measured using the Feeling Scale, an 11-point single-item measure ranging from -5 to +5, with higher scores indicating more positive affective valence. Mean or model-estimated mean scores were summarized by condition and treadmill phase. |
| Primary | Mean Physical Comfort/Tiredness Rating During Each Treadmill Exercise Phase | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Physical comfort/tiredness was measured using an 11-point single-item rating ranging from -5 to +5, with higher scores indicating greater physical comfort or lower tiredness. Mean or model-estimated mean scores were summarized by condition and treadmill phase. |
| Secondary | Number and Percentage of Experimental Sessions Delivered as Planned | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Protocol fidelity was summarized as the number and percentage of started experimental sessions delivered using the participant-specific treadmill speed protocol, assigned audio condition, safety harness, front-handle contact procedure, and planned 25-minute treadmill duration, without documented protocol deviations. |
| Secondary | Percentage of Expected Affective-Experience and Acceptability Data Obtained | From the second laboratory visit through the final comparative interview at the fifth laboratory visit, an average of 24 days | Data completeness was summarized as the percentage of expected observations obtained for emotional feeling, physical comfort/tiredness, perceived attentional/interoceptive cue-following, and final comparative interview responses. |
| Secondary | Mean Custom Perceived Attentional and Interoceptive Cue-Following Rating Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Perceived attentional and interoceptive cue-following was measured after each experimental treadmill session using a custom single-item scale titled the Perceived Attentional and Interoceptive Cue-Following Rating. Possible scores ranged from 1 to 10. Higher scores indicate greater perceived success clearing the mind and focusing on breathing during exercise, representing stronger engagement with the intended attentional and interoceptive exercise instructions. Mean scores were summarized by condition and exposure. |
| Secondary | Number and Percentage of Participants Reporting Condition Preference | From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days | Condition preference was summarized as the number and percentage of participants who preferred ECI-AE, preferred the matched eyes-open control condition, or reported no preference during the final comparative interview. |
| Secondary | Number and Percentage of Participants Reporting Better, Worse, or Same Second ECI-AE Exposure | From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days | Adaptation to ECI-AE was summarized as the number and percentage of participants who described the second ECI-AE exposure as better, worse, or the same compared with the first ECI-AE exposure. Open-ended explanations were used to characterize perceived familiarity, comfort, confidence, or remaining concerns. |
| Secondary | Mean Postexercise Seated-Recovery Feeling Scale Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Postexercise seated-recovery emotional feeling was measured using the Feeling Scale, an 11-point single-item measure ranging from -5 to +5, with higher scores indicating more positive affective valence. Mean scores were summarized by condition and exposure. |
| Secondary | Mean Postexercise Seated-Recovery Physical Comfort/Tiredness Rating | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Postexercise seated-recovery physical comfort/tiredness was measured using an 11-point single-item rating ranging from -5 to +5, with higher scores indicating greater physical comfort or lower tiredness. Mean scores were summarized by condition and exposure. |
| Secondary | Change From Pre-Session to Post-Session State Anxiety Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | State anxiety was measured before and after each experimental session using the State-Trait Anxiety Inventory-State Form. The scale includes 20 items rated from 1 to 4, producing a total score ranging from 20 to 80 after appropriate reverse scoring. Higher scores indicate greater state anxiety. Change scores were calculated as post-session score minus pre-session score and summarized by condition. |
| Secondary | Change From Pre-Session to Post-Session Affective State Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Exercise-induced affective state was measured before and after each experimental session using the Exercise-Induced Affect Scale questionnaire. Mean item scores ranged from 1 to 5, with higher scores indicating greater intensity of the specific affective state being rated. Change scores were calculated as post-session score minus pre-session score and summarized by condition. |
| Secondary | Mean Post-Session Condition-Specific Exercise Attitude Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Exercise attitude was measured after each experimental session using custom bipolar adjective ratings of the completed exercise condition. Items were rated from 1 to 9. Higher scores indicate a more favorable attitude toward the completed exercise condition. Mean scores were summarized by condition. |
| Secondary | Mean Post-Session Condition-Specific Exercise Intention Score | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Exercise intention was measured after each experimental session using custom condition-specific items rated from 1 to 5. Higher scores indicate stronger intention to perform the relevant exercise type in the future. After matched eyes-open control sessions, items assessed intention and motivation for treadmill exercise. After ECI-AE sessions, items assessed intention and motivation for meditation-infused or eyes-closed interoceptive aerobic exercise. Mean scores were summarized by condition. |
| Other | Mean Heart Rate During Treadmill Exercise and Recovery | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Heart rate was recorded in beats per minute using a heart-rate strap during experimental visits. Mean heart rate values were summarized during the 25-minute treadmill exercise bout and postexercise seated recovery period by condition, session, treadmill phase, or recovery period. Higher values indicate higher heart rate in beats per minute. |
| Other | Mean Heart-Rate Variability During Seated Rest and Recovery | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Heart-rate variability was derived from heart-rate recordings collected during seated rest and postexercise seated recovery periods. HRV indices, such as root mean square of successive differences or other protocol-specified HRV metrics, were summarized by condition and time period. Higher scores indicate greater heart-rate variability for the specific HRV metric reported. |
| Other | Change From Pre-Exercise to Postexercise Systolic and Diastolic Blood Pressure | From the second laboratory visit through the fifth laboratory visit, an average of 24 days | Systolic and diastolic blood pressure were measured in millimeters of mercury before treadmill exercise, immediately after treadmill exercise, and after postexercise seated recovery at each experimental visit. Change scores were summarized by condition. Higher values indicate higher blood pressure. |
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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