- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703839
Effects of Breath-Hold vs Standard Interval Training on Fitness in Mountaineers
Effects of Mild Voluntary Hypoventilation During Progressive Interval Training on Cardiorespiratory Fitness in Recreational Mountaineers: A Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Recreational mountaineers often train at low altitudes without access to specialized hypoxic facilities. While intermittent hypoxic training is an established preparation strategy, the required equipment is costly and inaccessible. Voluntary hypoventilation training (VHT), which involves deliberate breath-holds during exercise, has been proposed as a low-cost alternative. However, its efficacy at producing mild desaturation levels suitable for recreational settings had not been established.
This retrospective clinical trial evaluated the effects of mild VHT on cardiorespiratory fitness. Twenty-four male recreational mountaineers completed a progressive 8-week treadmill interval training program (24 sessions, 65-85% heart rate reserve) between September and November 2023. Participants were allocated to either a controlled-breathing (CB) group or a free-breathing (FB) group. The CB group performed structured mid-tidal breath-holds synchronized to an electronic metronome during approximately 25% of the main training phase, targeting a peripheral oxygen saturation (SpO₂) nadir of 92-94%. The FB group completed the identical exercise protocol with unrestricted breathing, maintaining SpO₂ at or above 97%.
Physiological assessments were conducted at baseline and within 48 hours post-intervention. Measurements included resting cardiovascular parameters (heart rate and blood pressure), estimated maximal oxygen uptake (VO₂max) via a modified Bruce treadmill protocol, and comprehensive pulmonary function testing (spirometry). Continuous SpO₂ monitoring was utilized during all training sessions to ensure protocol adherence and participant safety.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sistan and Baluchestan
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Zahedan, Sistan and Baluchestan, Iran, 98135-986
- Sport Sciences Department, University of Sistan and Baluchestan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Male recreational mountaineers aged 25 to 35 years. A minimum of 6 months of mountaineering experience with at least 3 sessions per month.
Willingness to attend at least 85% of the scheduled training sessions. Negative responses to all items on the Physical Activity Readiness Questionnaire (PAR-Q).
Exclusion Criteria:
Diagnosed cardiovascular, respiratory, or musculoskeletal disorders. Current smoking. Use of medications affecting heart rate or blood pressure. Prior experience with structured hypoxic or breath-hold training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Controlled-Breathing (CB) Group
Participants completed 24 supervised treadmill interval sessions over 8 weeks (65-85% heart rate reserve).
During approximately 25% of the main training phase, participants performed structured mid-tidal breath-holds synchronized to an electronic metronome (progressing from 3-count to 6-count cycles), targeting a peripheral oxygen saturation (SpO₂) nadir of 92-94%.
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A breathing maneuver consisting of structured mid-tidal breath-holds synchronized to an electronic metronome to induce mild voluntary hypoventilation (target SpO₂ nadir 92-94%) during physical exertion.
Other Names:
A cardiovascular exercise protocol involving supervised treadmill sessions with progressive increases in intensity (65-85% heart rate reserve) and duration (30-45 minutes) over an 8-week period.
Other Names:
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Active Comparator: Free-Breathing (FB) Group
Participants completed the identical 24 supervised treadmill interval sessions over 8 weeks (65-85% heart rate reserve) with unrestricted breathing throughout all sessions.
Continuous SpO₂ monitoring confirmed values remained at or above 97%.
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A cardiovascular exercise protocol involving supervised treadmill sessions with progressive increases in intensity (65-85% heart rate reserve) and duration (30-45 minutes) over an 8-week period.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting Heart Rate
Time Frame: Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).
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Resting heart rate (beats per minute) recorded using a 12-lead electrocardiograph after 10 minutes of seated rest in a quiet, temperature-controlled room.
The mean value from the final 2 minutes is used for analysis.
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Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).
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Estimated Maximal Oxygen Uptake (VO2max)
Time Frame: Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).
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Estimated VO2max (mL·kg-¹·min-¹) determined using a modified Bruce treadmill protocol until volitional exhaustion.
It is calculated from total treadmill time (in minutes) using the Foster equation.
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Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Systolic Blood Pressure
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Systolic blood pressure (mmHg) measured in triplicate using an automated oscillometric monitor; the average of 3 measurements is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Diastolic Blood Pressure
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Diastolic blood pressure (mmHg) measured in triplicate using an automated oscillometric monitor; the average of 3 measurements is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Tidal Volume (TV)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Tidal volume (L) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Vital Capacity (VC)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Vital capacity (L) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Forced Vital Capacity (FVC)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Vital capacity (L) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Forced expiratory volume in 1 second (L) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Peak Expiratory Flow (PEF)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Peak expiratory flow (L/s) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Forced Expiratory Flow at 25-75% of FVC (FEF25-75%)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Forced expiratory flow at 25-75% of FVC (L/s) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Maximum Voluntary Ventilation (MVV)
Time Frame: Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Maximum voluntary ventilation (L/min) measured via calibrated spirometry; the highest value from three technically acceptable maneuvers is retained.
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Baseline and post-intervention (within 48 hours after the final 8-week training session).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohammadreza Rezaeipour, MD, PhD, University of Sistan and Baluchestan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IR.USB.REC.1402.013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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