NCT07703839

Brief Summary

This study investigated whether adding structured breath-holds to standard interval training improves cardiorespiratory fitness in recreational mountaineers more than interval training alone. Twenty-four male recreational mountaineers participated in an 8-week progressive treadmill interval training program. Participants were divided into two groups: a controlled-breathing group that performed structured mid-tidal breath-holds during training, and a free-breathing group that maintained unrestricted breathing. The primary outcomes measured were resting heart rate and estimated maximal oxygen uptake, along with secondary measures including blood pressure and pulmonary function indices. The study aimed to determine if this mild voluntary hypoventilation technique provides additional physiological benefits for altitude preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 9, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Voluntary hypoventilation trainingMountaineeringCardiorespiratory fitnessInterval trainingAcclimatizationAerobic capacityPulse oximetryBreath-Hold Training

Outcome Measures

Primary Outcomes (2)

  • Resting Heart Rate

    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.

    Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).

  • Estimated Maximal Oxygen Uptake (VO2max)

    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.

    Baseline (within 48 hours before the first training session) and post-intervention (within 48 hours after the final 8-week training session).

Secondary Outcomes (9)

  • Systolic Blood Pressure

    Baseline and post-intervention (within 48 hours after the final 8-week training session).

  • Diastolic Blood Pressure

    Baseline and post-intervention (within 48 hours after the final 8-week training session).

  • Tidal Volume (TV)

    Baseline and post-intervention (within 48 hours after the final 8-week training session).

  • Vital Capacity (VC)

    Baseline and post-intervention (within 48 hours after the final 8-week training session).

  • Forced Vital Capacity (FVC)

    Baseline and post-intervention (within 48 hours after the final 8-week training session).

  • +4 more secondary outcomes

Study Arms (2)

Controlled-Breathing (CB) Group

EXPERIMENTAL

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%.

Behavioral: Voluntary Hypoventilation TrainingBehavioral: Progressive Treadmill Interval Training

Free-Breathing (FB) Group

ACTIVE COMPARATOR

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%.

Behavioral: Progressive Treadmill Interval Training

Interventions

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.

Also known as: VHT; Breath-Hold Training
Controlled-Breathing (CB) Group

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.

Also known as: Interval Training; Treadmill Exercise
Controlled-Breathing (CB) GroupFree-Breathing (FB) Group

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Sciences Department, University of Sistan and Baluchestan

Zahedan, Sistan and Baluchestan, 98135-986, Iran

Location

Study Officials

  • Mohammadreza Rezaeipour, MD, PhD

    University of Sistan and Baluchestan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and training supervisors were unblinded to the breathing intervention. The technician conducting spirometry assessments was blinded to group allocation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A two-arm parallel-group design comparing a controlled-breathing interval training group to a free-breathing interval training group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 14, 2026

Study Start

September 30, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

The de-identified dataset and full study protocol are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Without end date
Access Criteria
Available from the corresponding author upon reasonable request.

Locations