- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406386
Integrating Halotherapy Into Preseason Training Improves Respiratory and Aerobic Performance in Elite Female Soccer Players
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aerobic capacity and respiratory efficiency are critical determinants of performance in elite soccer. Halotherapy, a non-pharmacological intervention involving inhalation of dry salt aerosol in a controlled environment, has been shown to improve pulmonary health in clinical populations; however, evidence in athletic populations remains limited.
This randomized parallel-group trial was conducted during the preseason period of the Turkish Women's First League. Twenty-eight elite female soccer players were randomly allocated to a halotherapy group or a control group. Both groups completed an identical 12-week soccer training program. In addition to training, the halotherapy group underwent 45-minute halotherapy sessions three times per week in a controlled halochamber environment.
Outcome measures included maximal inspiratory and expiratory pressures (MIP, MEP), pulmonary function parameters (FVC, FEV₁, PEF, MVV), aerobic capacity estimated via the Yo-Yo Intermittent Recovery Test Level 1, and total distance covered in the Yo-Yo test. Measurements were collected before and after the intervention period. The study aimed to determine whether halotherapy provides additive benefits to standard soccer training in elite female athletes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane
-
Gümüşhane, Trabzon, Ordu, Giresun, Rize, Artvin, Gümüşhane, Turkey (Türkiye), 29600
- Gumushane Univetsity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Presence of respiratory, cardiovascular, or metabolic disease
- Current musculoskeletal injury
- Smoking
- Pregnancy
- Use of medications affecting respiratory or cardiovascular function
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Halotherapy Group
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%).
|
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%).
Participants followed the same standard preseason soccer training program without halotherapy.
|
|
No Intervention: CONTROL
Participants followed the same standard preseason soccer training program without halotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal Expiratory Pressure (MEP)
Time Frame: 12 week
|
Expiratory muscle strength measured using a portable respiratory pressure meter.
|
12 week
|
|
Maximal Inspiratory Pressure (MIP)
Time Frame: 12 week
|
Inspiratory muscle strength measured using a portable respiratory pressure meter.
|
12 week
|
|
Aerobic Capacity (VO₂max estimate)
Time Frame: 12 week
|
VO₂max estimated using the Yo-Yo Intermittent Recovery Test Level 1.
|
12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity (FVC)
Time Frame: 12 week
|
Measured by spirometry.
|
12 week
|
|
Forced Expiratory Volume in 1 Second (FEV₁)
Time Frame: 12 weeks
|
Measured by spirometry.
|
12 weeks
|
|
Peak Expiratory Flow (PEF)
Time Frame: 12 week
|
Measured by spirometry.
|
12 week
|
|
Yo-Yo Intermittent Recovery Test Level 1 Distance
Time Frame: 12 week
|
VO₂max estimated using the Yo-Yo Intermittent Recovery Test Level 1.
|
12 week
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/2-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Athletic Performance
-
Coşkun YILMAZCompletedAthletic Performance | Neuromuscular Adaptations | Athletic Performance EnhancementTurkey (Türkiye)
-
Shanghai University of SportRecruitingAthletic Performance | Physical PerformanceChina
-
Federal University of VicosaCompletedAthletic Performance | Sprint Performance | YouthsColombia
-
Mudanya UniversityNot yet recruitingAthletic PerformanceTurkey (Türkiye)
-
Monira AldhahiCompletedAthletic PerformanceTunisia
-
Universiti Putra MalaysiaCompletedEffect of Instability Resistance Training on Balance, Core Muscle Strength, and Athletic PerformanceAthletic PerformanceMalaysia
-
Institute of Sport - National Research Institute...CompletedAthletic PerformancePoland
-
University Ramon LlullMònica Solana-Tramunt; Jose MoralesCompleted
-
Per Bendix JeppesenFuture Food InnovationCompletedAthletic PerformanceDenmark
-
Metropolitan University, SerbiaCompletedAthletic PerformanceSerbia
Clinical Trials on Halotherapy Group
-
Gümüşhane UniversıtyCompletedBody Composition | Physical Fitness | Halotherapy | Zumba ExerciseTurkey (Türkiye)
-
Igdir UniversityCompleted
-
Tecno Sun SRLCentro Studi GisedTerminatedSleep Apnea, ObstructiveItaly
-
Tecno Sun SRLCentro Studi GisedWithdrawnInverse Psoriasis | SebopsoriasisItaly
-
Tanta UniversityCompletedChildren | Dexmedetomidine | Adenotonsillectomy | MidazolamEgypt
-
Tanta UniversityNot yet recruitingMelatonin | Doxorubicin | Vitamin D Concentration | Breast Cancer Patients DiagnosedEgypt
-
Charite University, Berlin, GermanyDepartment of Neurology, Charité - Universitätsmedizin Berlin, Germany; Department...Unknown
-
University of Sao Paulo General HospitalCompletedOsteoarthritis, Knee
-
Cairo UniversityCompleted
-
Al-Azhar UniversityCompleted