Eyes-Closed Interoceptive Aerobic Exercise Compared With Matched Eyes-Open Treadmill Exercise in Healthy Adults (ECI-AE Pilot)
28 de maio de 2026 atualizado por: Yubing Wang, Ph.D, Old Dominion University
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
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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Virginia
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Norfolk, Virginia, Estados Unidos, 23529-5000
- Old Dominion University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Sequence 1: Control, ECI-AE, Control, ECI-AE
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.
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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.
Outros nomes:
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.
Outros nomes:
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Experimental: Sequence 2: ECI-AE, Control, ECI-AE, Control
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.
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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.
Outros nomes:
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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number and Percentage of Participants Reaching Each Recruitment and Participation Milestone
Prazo: From screening through the fifth laboratory visit, up to 6 weeks per participant
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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.
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From screening through the fifth laboratory visit, up to 6 weeks per participant
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Number and Percentage of Randomized Participants Who Completed All Experimental Visits
Prazo: From randomization after the baseline/familiarization visit through the fifth laboratory visit, an average of 32 days
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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.
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From randomization after the baseline/familiarization visit through the fifth laboratory visit, an average of 32 days
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Number and Percentage of Planned Experimental Sessions Completed
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Number of Participants With Safety Events During Experimental Treadmill Sessions
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Feeling Scale Score During Each Treadmill Exercise Phase
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Physical Comfort/Tiredness Rating During Each Treadmill Exercise Phase
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number and Percentage of Experimental Sessions Delivered as Planned
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Percentage of Expected Affective-Experience and Acceptability Data Obtained
Prazo: From the second laboratory visit through the final comparative interview at the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the final comparative interview at the fifth laboratory visit, an average of 24 days
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Mean Custom Perceived Attentional and Interoceptive Cue-Following Rating Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Number and Percentage of Participants Reporting Condition Preference
Prazo: From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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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.
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From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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Number and Percentage of Participants Reporting Better, Worse, or Same Second ECI-AE Exposure
Prazo: From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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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.
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From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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Mean Postexercise Seated-Recovery Feeling Scale Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Postexercise Seated-Recovery Physical Comfort/Tiredness Rating
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Change From Pre-Session to Post-Session State Anxiety Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Change From Pre-Session to Post-Session Affective State Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Post-Session Condition-Specific Exercise Attitude Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Post-Session Condition-Specific Exercise Intention Score
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Heart Rate During Treadmill Exercise and Recovery
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Mean Heart-Rate Variability During Seated Rest and Recovery
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Change From Pre-Exercise to Postexercise Systolic and Diastolic Blood Pressure
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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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.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Change From Pre-Exercise to Postexercise Stroop Task Performance
Prazo: From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Cognitive performance was measured using a Stroop task before and after the treadmill exercise and recovery procedures at each experimental visit.
Outcomes included reaction time, accuracy, and/or Stroop interference indicators.
For reaction time and interference scores, higher values generally indicate slower or greater interference.
For accuracy, higher values indicate better performance.
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From the second laboratory visit through the fifth laboratory visit, an average of 24 days
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Number of Participants Reporting Open-Ended Acceptability and Experience Themes
Prazo: From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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Open-ended responses from the final comparative interview were coded to summarize participant-reported reasons for better, worse, or similar experiences between ECI-AE and the matched control condition.
Themes included perceived benefits, burdens, safety concerns, adaptation, breathing focus, mental quiet, physical tiredness, music or audio experience, and condition preference.
The number of participants endorsing each theme was summarized.
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From the baseline/familiarization visit through the final comparative interview at the fifth laboratory visit, an average of 32 days
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de outubro de 2024
Conclusão Primária (Real)
22 de dezembro de 2025
Conclusão do estudo (Real)
22 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ODU-ECIAE-PILOT-001
- 2169561-6 (Outro identificador: Old Dominion University)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
The study team is evaluating whether de-identified individual participant quantitative data can be shared in accordance with institutional review board requirements, participant consent, and institutional data-use policies.
Qualitative interview or open-ended response data may be restricted because of participant confidentiality and potential re-identification risk in a small single-site pilot sample.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .