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Eyes-Closed Interoceptive Aerobic Exercise Compared With Matched Eyes-Open Treadmill Exercise in Healthy Adults

Feasibility, Acceptability, Psychophysiological Responses, and Cognitive Effects of Prototype Eyes-Closed Interoceptive Aerobic Exercise Versus Matched Eyes-Open Treadmill Exercise: A Randomized Repeated-Exposure Crossover Pilot Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07625371
Acronym
ECI-AE Pilot
Enrollment
40
Registered
2026-06-04
Start date
2024-10-20
Completion date
2025-12-22
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affect and Exertion During and Post-exercise, Exercise, Healthy Adult, Interoception, Physical Activity

Brief summary

This completed single-site pilot trial evaluated a prototype eyes-closed interoceptive aerobic exercise condition compared with a matched eyes-open treadmill control condition in healthy adults. Participants attended one baseline/familiarization visit followed by four randomized experimental treadmill visits. Each participant completed the eyes-closed interoceptive aerobic exercise condition twice and the matched eyes-open control condition twice in one of two randomized sequences. Both conditions used the same individualized 25-minute treadmill protocol, 0% incline, safety harness, front-handle contact requirement, laboratory supervision, and staff-controlled speed transitions. The conditions differed in eye status, attentional instructions, and audio environment. The broader pilot project collected feasibility, safety, fidelity, acceptability, adaptation, affective-experience, cardiovascular/autonomic, blood-pressure, and cognitive-performance outcomes.

Interventions

BEHAVIORALEyes-Closed Interoceptive Aerobic Exercise

Eyes-closed interoceptive aerobic exercise was a prototype multicomponent treadmill exercise condition. Participants completed the individualized 25-minute treadmill protocol at 0% incline using five consecutive 5-minute phases: walking, brisk walking, jogging or faster walking, faster jogging or fastest walking, and walking recovery. Participants kept their eyes closed, wore a safety harness, and maintained light contact with the front treadmill handle for positional reference. Before the bout, participants were instructed to close their eyes, clear their mind, and focus on breathing. During exercise, soft meditative background music was played continuously, and brief prerecorded reminders were delivered every 2.5 minutes: "clear the mind," "focus on breathing," and "close your eyes." Before each experimental treadmill session in both conditions, participants were told they could breathe through the nose when possible.

BEHAVIORALMatched Eyes-Open Treadmill Exercise

The matched eyes-open treadmill exercise condition used the same individualized 25-minute treadmill protocol, 0% incline, five-phase structure, safety harness, front-handle contact requirement, laboratory supervision, and staff-controlled speed transitions as ECI-AE. Participants kept their eyes open. Before the bout, participants were told that a science audiobook would be played and that they could attend to or ignore it. No ECI-AE verbal reminders or meditative background music were delivered. The audiobook provided a standardized externally oriented audio context and avoided exercise-, emotion-, or meditation-related content. Before each experimental treadmill session in both conditions, participants were told they could breathe through the nose when possible.

Sponsors

Old Dominion University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Masking description

No masking was used. Participants and study staff were aware of the assigned condition because the experimental conditions differed visibly by eyes-closed versus eyes-open exercise and by audio content.

Intervention model description

After one baseline/familiarization visit, participants were randomized in a 1:1 allocation ratio to one of two repeated-exposure crossover sequences. During experimental visits 2-5, each participant completed the eyes-closed interoceptive aerobic exercise condition twice and the matched eyes-open treadmill control condition twice. Sequence 1 completed control, ECI-AE, control, and ECI-AE. Sequence 2 completed ECI-AE, control, ECI-AE, and control. The same individualized 25-minute treadmill-speed protocol determined during the baseline/familiarization visit was used across all four experimental visits in both conditions.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Adults aged 18 to 45 years * Prior experience exercising on a treadmill * Able and willing to attend one baseline/familiarization visit and four experimental laboratory visits * Able to complete supervised treadmill walking and jogging exercise under laboratory safety procedures * Able to provide informed consent

Exclusion criteria

* Physical health condition that would preclude safe participation in treadmill exercise * Pregnancy * Hypertension * Cardiac disorder * Arteriovenous shunt * Intravascular therapy * Blood-flow problems * Mastectomy * Mental health condition that would preclude safe participation in treadmill exercise * Diagnosed depression * Diagnosed anxiety * Any other condition or safety concern identified by study staff that would make participation unsafe or inappropriate

Design outcomes

Primary

MeasureTime frameDescription
Number and Percentage of Participants Reaching Each Recruitment and Participation MilestoneFrom screening through the fifth laboratory visit, up to 6 weeks per participantRecruitment 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.
Number and Percentage of Randomized Participants Who Completed All Experimental VisitsFrom randomization after the baseline/familiarization visit through the fifth laboratory visit, an average of 32 daysPost-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.
Number and Percentage of Planned Experimental Sessions CompletedFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysExperimental 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.
Number of Participants With Safety Events During Experimental Treadmill SessionsFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysSafety 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.
Mean Feeling Scale Score During Each Treadmill Exercise PhaseFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysEmotional 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.
Mean Physical Comfort/Tiredness Rating During Each Treadmill Exercise PhaseFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysPhysical 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

MeasureTime frameDescription
Number and Percentage of Experimental Sessions Delivered as PlannedFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysProtocol 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.
Percentage of Expected Affective-Experience and Acceptability Data ObtainedFrom the second laboratory visit through the final comparative interview at the fifth laboratory visit, an average of 24 daysData 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.
Mean Custom Perceived Attentional and Interoceptive Cue-Following Rating ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysPerceived 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.
Number and Percentage of Participants Reporting Condition PreferenceFrom the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 daysCondition 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.
Number and Percentage of Participants Reporting Better, Worse, or Same Second ECI-AE ExposureFrom the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 daysAdaptation 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.
Mean Postexercise Seated-Recovery Feeling Scale ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysPostexercise 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.
Mean Postexercise Seated-Recovery Physical Comfort/Tiredness RatingFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysPostexercise 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.
Change From Pre-Session to Post-Session State Anxiety ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysState 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.
Change From Pre-Session to Post-Session Affective State ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysExercise-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.
Mean Post-Session Condition-Specific Exercise Attitude ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysExercise 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.
Mean Post-Session Condition-Specific Exercise Intention ScoreFrom the second laboratory visit through the fifth laboratory visit, an average of 24 daysExercise 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026