Eyes-Closed Interoceptive Aerobic Exercise Compared With Matched Eyes-Open Treadmill Exercise in Healthy Adults (ECI-AE Pilot)

Old Dominion University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07625371

ODU-ECIAE-PILOT-001

2169561-6 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Matched Eyes-Open Treadmill Exercise

Behavioral: Eyes-Closed Interoceptive Aerobic Exercise

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

Experimental group

Description:

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.

Treatment:

Behavioral: Matched Eyes-Open Treadmill Exercise

Behavioral: Eyes-Closed Interoceptive Aerobic Exercise