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Physiological Performance in Healthy Female AthletesNCT07083258

The Effect of Inspiratory Muscle Training on Respiratory Parameters, Balance, Trunk Endurance and Trunk Isokinetic Muscle Strength in Wrestling Athletes

A study testing Progressive Inspiratory Muscle Training (IMT) in people with Physiological Performance in Healthy Female Athletes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Title: The Effects of Inspiratory Muscle Training on Respiratory Parameters, Balance, Trunk Endurance, and Trunk Isokinetic Muscle Strength in Elite Female Freestyle Wrestlers Objective: This experimental study aims to investigate the effects of inspiratory muscle training on respiratory functions, trunk muscle… Read more about this study

Who is it for?
Ages 16 to 22 years, women onlyHealthy volunteers can take part
What is being tested?
Progressive Inspiratory Muscle Training (IMT)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 22 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • To be an athlete in the Freestyle Women's Wrestling branch.
  • Participating in regular training at least 4 days a week.
  • To volunteer to participate in the study.
  • Being an athlete within TOHM for at least one year.
  • To be between the ages of 16-22.

Who cannot join

  • Have a cardiopulmonary disease that precludes the use of Pulmonary Function Testing.
  • Have specific balance problems (e.g., vestibular or neurological impairment).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Ondokuz Mayıs Üniversitesi

    Samsun

    Ondokuz Mayıs Üniversitesi, +90 0 (362) 312 19 19, mine.pekesenkurtca@omu.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Inspiratory Muscle Training on Respiratory Parameters, Balance, Trunk Endurance and Trunk Isokinetic Muscle Strength in Elite Freestyle Female Wrestling Athletes

Title:

The Effects of Inspiratory Muscle Training on Respiratory Parameters, Balance, Trunk Endurance, and Trunk Isokinetic Muscle Strength in Elite Female Freestyle Wrestlers

Read more

Objective:

This experimental study aims to investigate the effects of inspiratory muscle training on respiratory functions, trunk muscle strength, endurance, and balance in elite female freestyle wrestlers.

Methods:

This randomized controlled trial will include 30 elite female freestyle wrestlers aged between 16 and 22. Participants will be randomly assigned to either an intervention group or a placebo control group using a simple randomization method. The intervention group will receive progressive inspiratory muscle training with the POWERbreathe Plus device, 5 days per week for 4 weeks. The training load will increase weekly. The control group will undergo low-resistance inspiratory training set at 15% of their baseline maximal inspiratory pressure (MIP), serving as a placebo. Pre- and post-intervention assessments will be conducted by a blinded evaluator.

Read the detailed description

This study aims to investigate the multifaceted effects of inspiratory muscle training (IMT) on performance parameters in elite female freestyle wrestlers within the field of cardiopulmonary physiotherapy and rehabilitation. Unlike most studies in the sports physiotherapy literature, this research goes beyond respiratory parameters to include key functional outcomes such as balance, trunk endurance, and isokinetic trunk muscle strength.

Scientific Background and Rationale Freestyle wrestling is a physically demanding sport that requires simultaneous, dynamic use of both upper and lower extremities, along with high levels of strength, balance, and coordination. Success in competition is closely linked to factors such as postural stability, core muscle activation, and the ability to generate isometric and dynamic force. However, the contribution of respiratory muscles to athletic performance has often been overlooked or assessed only indirectly in previous studies.

Given the high-intensity and short-duration nature of wrestling matches, increased ventilatory demand places a significant burden on the diaphragm and accessory respiratory muscles. Recent evidence suggests that IMT not only improves pulmonary function but also enhances core stabilization and postural control. Therefore, directly assessing the effects of IMT on respiratory and trunk muscle performance in elite female wrestlers addresses a notable gap in the literature.

Study Design This is a randomized controlled experimental study involving 30 elite female freestyle wrestlers affiliated with the Turkish Olympic Preparation Center (TOHM-Trabzon). Participants will be randomly assigned into two groups (n=15 each) via simple randomization.

The intervention group will undergo IMT using the POWERbreathe Plus device, 5 days per week for 4 weeks. Training will begin at 50% of the participants' MIP and increase by 10% each week, reaching 80% by the final week.

The control group will receive placebo IMT at a constant load equivalent to 15% of baseline MIP, following the same training schedule.

All interventions will be delivered in addition to the athletes' regular training programs. Pre- and post-intervention assessments will be conducted by a blinded physiotherapist who is not involved in the implementation of the training.

Assessment Parameters and Instruments To comprehensively evaluate the impact of IMT, objective and validated tools will be employed. Pulmonary function will be assessed using the Cosmed Pony FX device, measuring MIP, MEP, FEV1, FVC, and the FEV1/FVC ratio. Trunk endurance will be evaluated using the McGill Core Endurance protocol, which includes tests for trunk flexion, extension, and lateral plank. Muscle strength will be measured using the Isomed 2000 isokinetic dynamometer at a velocity of 60°/s to determine peak torque during trunk flexion and extension. Balance performance will be assessed with both the Y Balance Test (in anterior, posterolateral, and posteromedial directions) and the Flamingo Balance Test, which measures the ability to maintain single-leg stance. In addition, a participant tracking form will be used to record demographic information, training history, and attendance. All assessments will be performed under standardized conditions by a blinded evaluator.

Statistical Methods Appropriate statistical methods will be employed to analyze the data. Distribution characteristics and group comparisons will be assessed accordingly. Intra-group and inter-group differences, as well as time-by-group interactions, will be analyzed. Effect sizes will be calculated using standard procedures, and statistical significance will be set at p < 0.05.

Original Contribution of the Study This study is unique in its comprehensive evaluation of the effects of IMT not only on performance-related physical parameters but also on cardiopulmonary capacity in elite athletes. By focusing specifically on female wrestlers, the study contributes to sex-specific physiological research and is expected to provide evidence for the development of clinically applicable IMT protocols aimed at enhancing athletic performance and health.

Being tested
Progressive Inspiratory Muscle Training (IMT), Placebo Training
Keywords
Inspiratory Muscle Training, Elite Athletes, Female Wrestlers, Trunk Muscle Endurance, Balance, Cardiopulmonary Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Inspiratory Muscle Training (IMT)Device

    The intervention involves the application of inspiratory muscle training using the POWERbreathe Plus device. Training will be conducted at an initial intensity of 50% of the individual's MIP and will be increased weekly by 10%, reaching 80% by week four. Sessions will take place 5 days per week and consist of 2 sets of 30 repetitions per day, with 2-minute rest intervals between sets. This training aims to improve inspiratory muscle strength and endurance, as well as core stability, respiratory function, dynamic balance, and trunk isokinetic strength.

  • Placebo TrainingOther

    The placebo group will perform identical training sessions using the same device but with a constant minimal resistance set at 15% of the initial MIP, insufficient to induce a physiological training effect. This intervention is designed to control for placebo response. Assessment protocols will be identical to those in the experimental group.

Study groups in NCT07083258
Study groupRoleWhat they receive
Inspiratory Muscle Training ProgramExperimentalParticipants in this group will receive a progressive inspiratory muscle training (IMT) program using the POWERbreathe Plus device. Training will be conducted 5 days per week for 4 weeks. The intensity will start at 50% of the participant's measured maximal inspiratory pressure (MIP) and will be increased by 10% each week, reaching 80% in the final week. All training will be performed in addition to the athletes' regular wrestling sessions. Participants in this group will be assessed for respiratory parameters, trunk endurance, balance, and trunk isokinetic muscle strength before and after the intervention.
Receives: Device: Progressive Inspiratory Muscle Training (IMT)
Control GroupPlacebo comparatorParticipants in the control group will receive a sham inspiratory muscle training program using the same device. The training intensity will be fixed at 15% of the initial MIP throughout the 4-week period to produce a placebo effect. The frequency and duration of training will mirror that of the experimental group. Participants will undergo identical pre- and post-intervention evaluations.
Receives: Other: Placebo Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Maximal Inspiratory Pressure (MIP) [cmH₂O]

    Maximal inspiratory pressure (MIP) will be measured using the Cosmed Pony FX device. This value reflects the strength of inspiratory muscles before and after the intervention.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  2. Change in Maximal Expiratory Pressure (MEP) [cmH₂O]

    Maximal expiratory pressure (MEP) will be assessed using the Cosmed Pony FX spirometer. It indicates the force generated by expiratory muscles and will be compared pre- and post-training.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  3. Change in Forced Expiratory Volume in 1 Second (FEV1) [liters]

    FEV1 will be measured using the Cosmed Pony FX to evaluate pulmonary function. The value reflects the volume of air expelled in the first second of a forced exhalation.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  4. Change in Forced Vital Capacity (FVC) [liters]

    FVC will be assessed with the Cosmed Pony FX device. It measures the total volume of air forcibly exhaled after a full inspiration, used to evaluate lung capacity changes due to training.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  5. Change in FEV1/FVC Ratio [%]

    The FEV1/FVC ratio will be calculated from pulmonary function testing to assess airway function and efficiency. The ratio will be compared between baseline and after the 4-week intervention.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

Secondary outcomes (9)
  1. Time Held in Trunk Flexion Test [seconds]

    Trunk flexion endurance will be assessed using the McGill Core Endurance Test Battery. The participant will maintain a trunk flexion position at a standardized angle. Duration will be recorded in seconds.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  2. Time Held in Side Plank Test [seconds]

    Lateral trunk endurance will be evaluated via the McGill side bridge (side plank) test. The time the participant can hold the position on each side will be recorded in seconds.

    Measured: Baseline (Week 0) and post-intervention (Week 4)

  3. Time Held in Trunk Extension Test [seconds]

    Trunk extension endurance will be measured with the McGill Core Endurance Test Battery. The participant will hold the trunk in an extended position; the time maintained will be recorded in seconds.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  4. Peak Torque of Trunk Flexors [Nm]

    Measured using the Isomed 2000 isokinetic dynamometer at 60°/s. Participants perform three trunk flexion repetitions; the highest peak torque value in Nm is recorded.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  5. Peak Torque of Trunk Extensors [Nm]

    Measured using the Isomed 2000 isokinetic dynamometer at 60°/s. Participants perform three trunk extension repetitions; the highest peak torque in Nm is recorded.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  6. Reach Distance in Y Balance Test - Anterior Direction [cm]

    The Y Balance Test will be used to assess dynamic balance. The maximum reach distance in the anterior direction will be measured in centimeters.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  7. Reach Distance in Y Balance Test - Posteromedial Direction [cm]

    The Y Balance Test will be used to assess dynamic balance. The maximum reach distance in the posteromedial direction will be measured in centimeters.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  8. Reach Distance in Y Balance Test - Posterolateral Direction [cm]

    The Y Balance Test will be used to assess dynamic balance. The maximum reach distance in the posterolateral direction will be measured in centimeters.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  9. Time Maintained in Flamingo Balance Test [seconds]

    Static balance will be assessed using the Flamingo Balance Test. The time (in seconds) the participant can maintain a single-leg stance on a beam without losing balance will be recorded.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083258
Sponsor's protocol ID
OMÜ2025/257
Status last verified
Nov 2025
First submitted
2 Jul 2025
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Inspiratory Muscle Training (IMT) in people with Physiological Performance in Healthy Female Athletes, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mine PEKEŞEN KURTÇA (+90 05079277327, mine.pekesenkurtca@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maximal Inspiratory Pressure (MIP) [cmH₂O] (time frame: Baseline (Week 0) and Post-intervention (Week 4)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.

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