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

NCT07625371 | Completed

• 2 other identifiers: ODU-ECIAE-PILOT-0012169561-6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Number and Percentage of Participants Reaching Each Recruitment and Participation Milestone

  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.

  From screening through the fifth laboratory visit, up to 6 weeks per participant

• Number and Percentage of Randomized Participants Who Completed All Experimental Visits

  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.

  From randomization after the baseline/familiarization visit through the fifth laboratory visit, an average of 32 days

• Number and Percentage of Planned Experimental Sessions Completed

  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.

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• Number of Participants With Safety Events During Experimental Treadmill Sessions

  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.

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• Mean Feeling Scale Score During Each Treadmill Exercise Phase

  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.

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• Mean Physical Comfort/Tiredness Rating During Each Treadmill Exercise Phase

  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.

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

Secondary Outcomes (11)

• Number and Percentage of Experimental Sessions Delivered as Planned

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• 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

• 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

• 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

• 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

Other Outcomes (5)

• Mean Heart Rate During Treadmill Exercise and Recovery

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• Mean Heart-Rate Variability During Seated Rest and Recovery

  From the second laboratory visit through the fifth laboratory visit, an average of 24 days

• 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

Study Arms (2)

Sequence 1: Control, ECI-AE, Control, ECI-AE

EXPERIMENTAL

Participants randomized to Sequence 1 completed the matched eyes-open treadmill control condition at experimental visits 1 and 3 and the eyes-closed interoceptive aerobic exercise condition at experimental visits 2 and 4. The same individualized 25-minute treadmill protocol, determined during the baseline/familiarization visit, was used across all four experimental visits.

Behavioral: Eyes-Closed Interoceptive Aerobic Exercise; Behavioral: Matched Eyes-Open Treadmill Exercise

Sequence 2: ECI-AE, Control, ECI-AE, Control

EXPERIMENTAL

Participants randomized to Sequence 2 completed the eyes-closed interoceptive aerobic exercise condition at experimental visits 1 and 3 and the matched eyes-open treadmill control condition at experimental visits 2 and 4. The same individualized 25-minute treadmill protocol, determined during the baseline/familiarization visit, was used across all four experimental visits.

Behavioral: Eyes-Closed Interoceptive Aerobic Exercise; Behavioral: Matched Eyes-Open Treadmill Exercise

Interventions

Eyes-Closed Interoceptive Aerobic Exercise BEHAVIORAL

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.

Also known as: ECI-AE, Eyes-closed interoceptive treadmill exercise, Prototype eyes-closed interoceptive aerobic exercise

Sequence 1: Control, ECI-AE, Control, ECI-AE; Sequence 2: ECI-AE, Control, ECI-AE, Control

Matched Eyes-Open Treadmill Exercise BEHAVIORAL

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.

Also known as: Eyes-open treadmill control, Conventional eyes-open treadmill exercise

Sequence 1: Control, ECI-AE, Control, ECI-AE; Sequence 2: ECI-AE, Control, ECI-AE, Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Old Dominion University: lead

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529-5000, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 4, 2026
• Study Start: October 20, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (1)