NCT07083258

Brief 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 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.

Trial Health

63
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

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

Study Progress38%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

July 2, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

July 2, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Inspiratory Muscle TrainingElite AthletesFemale WrestlersTrunk Muscle EnduranceBalanceCardiopulmonary Rehabilitation

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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.

    Baseline (Week 0) and Post-intervention (Week 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.

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

  • 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.

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

Secondary Outcomes (9)

  • Time Held in Trunk Flexion Test [seconds]

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

  • Time Held in Side Plank Test [seconds]

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

  • Time Held in Trunk Extension Test [seconds]

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

  • Peak Torque of Trunk Flexors [Nm]

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

  • Peak Torque of Trunk Extensors [Nm]

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

  • +4 more secondary outcomes

Study Arms (2)

Inspiratory Muscle Training Program

EXPERIMENTAL

Participants 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.

Device: Progressive Inspiratory Muscle Training (IMT)

Control Group

PLACEBO COMPARATOR

Participants 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.

Other: Placebo Training

Interventions

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.

Inspiratory Muscle Training Program

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.

Control Group

Eligibility Criteria

Age16 Years - 22 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs Üniversitesi

Samsun, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 24, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11

Locations