Clinical trial NCT06951633: Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.
Official title: Functional Efficiency, Respiratory Parameters and Blood Rheological Tests in Elderly People With Respiratory Diseases Participating in Pulmonary Rehabilitation in Underground Salt Chambers - a Prospective Experimental Study, Controlled in a Crossover Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: the Elderly
Respiratory Disorders
Keywords: Pulmonary function, speleotherapy, blood tests, 6MWT, chest
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Prospective, Controlled, Crossover Study.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory muscle force: Maximal inspiratory pressure - MIP
timeFrame: up to 18 months
measure: Respiratory muscle force: Maximal expiratory pressure - MEP
timeFrame: up to 18 months
measure: Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP
timeFrame: up to 18 months
measure: 6-Minute Walk Test - 6MWT
timeFrame: up to 18 months
measure: The Aggregation Index (AI)
timeFrame: up to 18 months
measure: The half-time of total aggregation (T1/2)
timeFrame: up to 18 months
measure: The Elongation Index (EI)
timeFrame: up to 18 months
measure: 4- Meters Gait Speed Test - 4MGST
timeFrame: up to 18 months
measure: Health Related Quality of Life - HRQoL withe the use of 15D questionnaire.
timeFrame: up to 18 months
measure: Chest mobility
timeFrame: up to 18 months
measure: Back scratch test
timeFrame: up to 18 months
measure: Interleukin IL 1b
timeFrame: up to 18 months
measure: Interleukin IL-6
timeFrame: up to 18 months
measure: TNF-alfa
timeFrame: up to 18 months
measure: WBC [10⁹/l]
timeFrame: up to 18 months
measure: RBC [10¹²/l],
timeFrame: up to 18 months
measure: HGB [g/dl]
timeFrame: up to 18 months
measure: HCT [%]
timeFrame: up to 18 months
measure: MCV [fl]
timeFrame: up to 18 months
measure: MCH [pg]
timeFrame: up to 18 months
measure: MCHC [g/dl]
timeFrame: up to 18 months
measure: PLT [109/l]
timeFrame: up to 18 months
measure: Reticulocytes {% or ‰]
timeFrame: up to 18 months
measure: CRP [mg/l]
timeFrame: up to 18 months
measure: Fibrinogen [g/l]
timeFrame: up to 18 months
measure: ESR [mm/h]
timeFrame: up to 18 months
Secondary outcomes:
measure: FEV₁
timeFrame: 2 weeks
measure: FVC
timeFrame: 2 weeks
measure: PEF
timeFrame: 2 weeks
measure: Bronchodilator Reversibility (BDR) Test
timeFrame: 2 weeks
measure: Resting tongue posture
timeFrame: 2 weeks
measure: 3-Day Food Diary
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Wieliczka
country: Poland
facility: Health Resort 'Wieliczka' Salt Mine in Wieliczka
Study officials:
affiliation: University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków
name: Sylwia Mętel, PhD
role: STUDY_DIRECTOR
References: