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Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.

NCT ID: NCT06951633

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2026-02-28

Brief Summary

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The aim of the study is to assess the impact of the rehabilitation and treatment stay at the underground Health Resort of the 'Wieliczka' Salt Mine in Wieliczka on the functional capacity, respiratory parameters, and rheological properties of blood in elderly individuals with respiratory diseases.

Detailed Description

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The research project will involve patients aged 65 and older with chronic respiratory diseases. Based on controlled studies conducted at the Health Resort "Wieliczka" Salt Mine in Wieliczka, and assuming the project will be a prospective, experimental, controlled study with a crossover design, calculations were made for the primary variable under investigation (exercise tolerance). These calculations determined that 29 pairs of participants are needed to achieve a statistical power of 80% and a significance level of 5% (bilateral). To detect a mean difference between pairs of 58, assuming a standard deviation of 106 for these differences and accounting for a 10% loss of participants from observation, the required sample size was increased to 33 pairs. Given the crossover design, the study plans to include 33 patients.

Volunteers will undergo qualifying tests, measurements of functional fitness, respiratory indicators, and blood rheology tests 3 weeks prior to the start of the rehabilitation and therapeutic stay in the underground salt chambers (1st test). During the 3-week period before the rehabilitation, participants will not engage in any other form of therapeutic rehabilitation. Functional fitness, respiratory indicators, and blood rheology tests will be repeated before the start of the stay (2nd test), immediately after its completion (3rd test), and 3 months after its completion (4th follow-up test). Each day of the rehabilitation and therapeutic stay will include a 2.5-hour visit to the underground health resort under the supervision of a doctor, physiotherapist, and nurse, during which pulmonary rehabilitation will be implemented.

Conditions

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the Elderly Respiratory Disorders

Keywords

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Pulmonary function, speleotherapy, blood tests, 6MWT, chest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A Prospective, Controlled, Crossover Study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subterranean, pulmonary rehabilitation

Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort

Group Type OTHER

Subterranean, pulmonary rehabilitation

Intervention Type OTHER

Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine

Interventions

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Subterranean, pulmonary rehabilitation

Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* people aged 65 and older with chronic respiratory diseases in a stable period of the disease (without exacerbations), qualified to participate in a rehabilitation and treatment stay in the underground Health Resort 'Wieliczka' Salt Mine in Wieliczka,
* patients who gave informed, written consent to participate in the study.

Exclusion Criteria

* patients with contraindications to subterraneotherapy and physical exercise,
* lack of written consent to participate in the study,
* deterioration of health during the implementation of the program.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University School of Physical Education, Krakow, Poland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylwia Mętel, PhD

Role: STUDY_DIRECTOR

University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków

Locations

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Health Resort 'Wieliczka' Salt Mine in Wieliczka

Wieliczka, Wieliczka, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Sylwia Mętel, PhD

Role: CONTACT

Phone: +48606480472

Email: [email protected]

Magdalena Kostrzon, PhD

Role: CONTACT

Phone: +48602713143

Email: [email protected]

Facility Contacts

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Magdalena Kostrzon, PhD

Role: primary

Marek Koprowski, PhD

Role: backup

Other Identifiers

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No. 022/ RID/SP/0027/2024/01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

29/RID/2025

Identifier Type: -

Identifier Source: org_study_id