NCT07406386

Brief Summary

This randomized controlled trial aimed to investigate the effects of a 12-week halotherapy intervention on respiratory muscle strength, pulmonary function, aerobic capacity, and intermittent running performance in elite female soccer players. Participants were randomly assigned to either a halotherapy group or a control group. Both groups followed the same preseason soccer training program, while the halotherapy group additionally received regular halotherapy sessions. Pre- and post-intervention assessments included spirometric measurements, respiratory muscle strength, estimated VO₂max, and Yo-Yo Intermittent Recovery Test Level 1 performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

April 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

HalotherapyElite female soccer playersRespiratory muscle strengthPulmonary functionAerobic capacityNon-pharmacological intervention

Outcome Measures

Primary Outcomes (3)

  • Maximal Expiratory Pressure (MEP)

    Expiratory muscle strength measured using a portable respiratory pressure meter.

    12 week

  • Maximal Inspiratory Pressure (MIP)

    Inspiratory muscle strength measured using a portable respiratory pressure meter.

    12 week

  • Aerobic Capacity (VO₂max estimate)

    VO₂max estimated using the Yo-Yo Intermittent Recovery Test Level 1.

    12 week

Secondary Outcomes (4)

  • Forced Vital Capacity (FVC)

    12 week

  • Forced Expiratory Volume in 1 Second (FEV₁)

    12 weeks

  • Peak Expiratory Flow (PEF)

    12 week

  • Yo-Yo Intermittent Recovery Test Level 1 Distance

    12 week

Study Arms (2)

Halotherapy Group

EXPERIMENTAL

Participants followed the standard preseason soccer training program and additionally received halotherapy. Halotherapy sessions were conducted in a controlled halochamber using a dry salt aerosol generator. Sessions lasted 45 minutes and were performed three times per week for 12 weeks. Aerosol concentration was maintained at approximately 20 mg/m³ with particle size \<5 microns. Environmental conditions were controlled (temperature 20-24°C, humidity 40-60%).

Other: Halotherapy GroupOther: Control

CONTROL

NO INTERVENTION

Participants followed the same standard preseason soccer training program without halotherapy.

Interventions

Participants followed the standard preseason soccer training program and additionally received halotherapy. Halotherapy sessions were conducted in a controlled halochamber using a dry salt aerosol generator. Sessions lasted 45 minutes and were performed three times per week for 12 weeks. Aerosol concentration was maintained at approximately 20 mg/m³ with particle size \<5 microns. Environmental conditions were controlled (temperature 20-24°C, humidity 40-60%).

Halotherapy Group
ControlOTHER

Participants followed the same standard preseason soccer training program without halotherapy.

Halotherapy Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale soccer players aged 18-30 years Competing in the Turkish Women's First League Minimum of 5 years of competitive soccer experience
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female soccer players aged 18-30 years
  • Competing in the Turkish Women's First League
  • Minimum of 5 years of competitive soccer experience
  • Regular training ≥10 hours per week
  • Free from injury at study entry
  • Non-smokers
  • Not using chronic medication
  • Provided written informed consent

You may not qualify if:

  • Presence of respiratory, cardiovascular, or metabolic disease
  • Current musculoskeletal injury
  • Smoking
  • Pregnancy
  • Use of medications affecting respiratory or cardiovascular function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gumushane Univetsity

Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Halotherapy sessions were conducted in a controlled halochamber using a dry salt aerosol generator. Sessions lasted 45 minutes and were performed three times per week for 12 weeks. Aerosol concentration was maintained at approximately 20 mg/m³ with particle size \<5 microns. Environmental conditions were controlled (temperature 20-24°C, humidity 40-60%).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

April 5, 2022

Primary Completion

July 15, 2022

Study Completion

July 20, 2022

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves a small sample of elite athletes from a single professional team, which may increase the risk of indirect participant identification. Additionally, the informed consent obtained from participants did not include explicit permission for public sharing of individual-level data. Data are therefore available only in aggregated form to protect participant confidentiality.

Locations