NCT07326462

Brief Summary

This study aims to determine the effects of different breathing patterns on ocular vasculature and intraocular pressure (IOP) during isokinetic and isometric strength exercises. It is hypothesized that higher ocular microcirculation changes and IOP values will be observed during the Valsalva maneuver compared to normal breathing in both exercise types. Additionally, ocular microcirculation and IOP changes are expected to be more pronounced during isometric exercises than during isokinetic exercises. The results will help establish optimal strength training strategies for both professional athletes and physically active individuals.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

December 17, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

intraocular pressureexerciseValsalva maneuverretinal vessels

Outcome Measures

Primary Outcomes (9)

  • 1. Intraocular Pressure (IOP)

    Tool: Icare portable tonometer (Icare, Tiolat Oy, Helsinki, Finland). Description: Measures the pressure inside the eye, caused by the aqueous humor pressing against the eye wall. Rationale: IOP is a key factor in glaucoma development and progression. Monitoring fluctuations during exercise and different breathing techniques is critical. Timing: Baseline (before exercise), immediately post-exercise, and at 5, 10, 15 minutes after exercise.

    3 days

  • 2. Retinal Microcirculation

    Tool: Aurora handheld non-mydriatic fundus camera (Optomed, Finland). Description: Digital fundus photography to measure retinal vessel diameters (arterioles and venules) in the superior and inferior temporal quadrants, near the optic disc margin. Rationale: Retinal vessel diameter is a biomarker for cardiovascular health and provides insights into ocular blood flow changes during stress. Timing: Same schedule as IOP (before, immediately after, and 5, 10, 15 minutes post-exercise).

    3 days

  • 3. Blood pressure (BP)

    Tool: Omron BP742N automatic arm blood pressure monitor (Omron Healthcare, Japan). Description: Monitors systolic and diastolic blood pressure levels. Rationale: To capture systemic cardiovascular responses during isometric vs. isokinetic exercise and different breathing conditions. Timing: Baseline, immediately after, 5, 10, and 15 minutes post-exercise.

    3 days

  • 4. Oxygen Saturation (SpO₂)

    Tool: Pulse oximeter (Omron). Description: Monitors peripheral blood oxygen levels. Rationale: Evaluates systemic oxygen delivery and breathing effects (especially relevant with Valsalva maneuver). Timing: During the exercise protocol (exact points not deeply detailed in file but implied to match BP).

    3 days

  • 5. Eye Dryness

    Tool: Schirmer Test (TearFlo strips). Description: Filter paper strips placed inside the lower eyelid for 5 minutes; length of wetting indicates tear production. Rationale: Assesses ocular surface health, as exercise and breathing methods may influence tear production and comfort. Timing: At baseline (before experimental trials).

    3 days

  • 6. Anthropometric Data

    Tools: Leicester Height Metre for height. Tanita TBF-300 body composition scale for weight and body fat %. Derived Measurement: Body Mass Index (BMI = weight/height²). Rationale: Provides participant characteristics for standardization and analysis.

    3 days

  • Questionaire no. 1

    Validated Baecke questionnaire → Physical activity level. Rationale: Captures subjective perception of workload alongside physiological measures.

    3 days

  • Questionnaire no.2

    Fatigue assessment questionnaires → Subjective fatigue. Rationale: Captures subjective perception of fatigue alongside physiological measures.

    3 days

  • Questionnaire no. 3

    Rating of Perceived Exertion (RPE) → Subjective exercise intensity. Rationale: Captures subjective perception of exertion alongside physiological measures.

    3 days

Study Arms (2)

Isokinetic exercise arm

EXPERIMENTAL

Protocol: Participants perform a 1-minute maximal voluntary isometric contraction of the knee extensors using a BIODEX dynamometer. Load setting: The maximum isometric load that each individual can sustain for 1 minute is determined during familiarisation. In the main session, participants work at 80% of their predetermined maximum load to avoid premature muscle failure. Nature of exercise: Static contraction (muscle generates force without changing length).

Diagnostic Test: Normal BreathingDiagnostic Test: Valsalva maneuver

Isometric exercise arm

EXPERIMENTAL

Protocol: Participants perform 1 minute of repeated isokinetic knee extensions and flexions at a controlled angular velocity on the BIODEX dynamometer. Velocity settings: Knee extension at 30°/s and knee flexion at 60°/s within the 0°-90° range of motion (0° = full extension). Nature of exercise: Dynamic contraction (muscle changes length while producing force against constant velocity resistance).

Diagnostic Test: Normal BreathingDiagnostic Test: Valsalva maneuver

Interventions

Normal BreathingDIAGNOSTIC_TEST

Participants perform the isometric or isokinetic exercise while following a controlled breathing rhythm: Inhale for 3 seconds Exhale for 3 seconds Breathing remains steady and continuous throughout the 1-minute exercise. Rationale: Represents a natural and safe breathing pattern during physical exertion, serves as the physiological baseline condition.

Isokinetic exercise armIsometric exercise arm
Valsalva maneuverDIAGNOSTIC_TEST

Participants perform the same isometric or isokinetic exercise but finish the trial with a 10-second breath-hold at the end of the 1-minute exercise. This maneuver increases intrathoracic and intra-abdominal pressures, which are transmitted to ocular and vascular systems. Rationale: Common in athletic performance, but may cause significant intraocular pressure and retinal vascular fluctuations.

Isokinetic exercise armIsometric exercise arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects 18-40 years old
  • Peak IOP \<21 mmHg in the modified DTC
  • Open angle at gonioscopy
  • Optic disc with cup-to-disc ratio \<0.6 with no signs of glaucomatous neuropathy
  • Not currently taking any medication
  • Non-smokers, no physical and mental disabilities
  • Blood pressure up 120/80 mmHg and heart rate (HR) 60-90 rpm at rest
  • BMI (18.5-34.8) kg/m2

You may not qualify if:

  • Presence of any ocular disease (with the exception of refractive errors)
  • Anxiety or depressive disorders
  • History of ocular trauma or surgery
  • Pregnancy
  • Use of any kind of oral/topical steroids
  • Any diagnosed chronic health condition such as cardiovascular disease including hypertension and or previous physical injuries that could impact their safe participation
  • Evidence of ocular pathology due to narrow anterior chamber angles, elevated IOP greater than or equal to 21mm Hg, optic nerve or retinal pathology, cup: disc ratio of greater than 0.6 or asymmetry of cup: disc ratio of greater than 0. 2.
  • Refractive error more than ±4.00 diopters, astigmatism greater than 3.00 diopters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • Vytautas Streckis, phD, Prof.

    Lithuanian Sports University

    STUDY DIRECTOR

Central Study Contacts

Monika Vieversyte-Dvyliene, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes Assessor)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: This is a crossover experimental study with 60 healthy adults, where each participant completes two exercise arms (isometric vs. isokinetic) under two breathing interventions (normal vs. Valsalva), separated by 2-3 days. The design allows controlled comparison of ocular and systemic responses to exercise and breathing techniques within the same individuals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 8, 2026

Study Start

January 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01