Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subterranean, pulmonary rehabilitation.
- Who it may be relevant to
- Registry conditions: the Elderly, Respiratory Disorders. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Subterranean, pulmonary rehabilitation
Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine
Primary outcome measures
- Respiratory muscle force: Maximal inspiratory pressure - MIP [Time frame: up to 18 months]
- Respiratory muscle force: Maximal expiratory pressure - MEP [Time frame: up to 18 months]
- Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP [Time frame: up to 18 months]
- 6-Minute Walk Test - 6MWT [Time frame: up to 18 months]
- The Aggregation Index (AI) [Time frame: up to 18 months]
- The half-time of total aggregation (T1/2) [Time frame: up to 18 months]
- The Elongation Index (EI) [Time frame: up to 18 months]
- 4- Meters Gait Speed Test - 4MGST [Time frame: up to 18 months]
- Health Related Quality of Life - HRQoL withe the use of 15D questionnaire. [Time frame: up to 18 months]
- Chest mobility [Time frame: up to 18 months]
Secondary outcome measures (6)
- FEV₁ [Time frame: 2 weeks]
- FVC [Time frame: 2 weeks]
- PEF [Time frame: 2 weeks]
- Bronchodilator Reversibility (BDR) Test [Time frame: 2 weeks]
- Resting tongue posture [Time frame: 2 weeks]
- 3-Day Food Diary [Time frame: up to 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Health Resort 'Wieliczka' Salt Mine in Wieliczka — Wieliczka
Identifiers
NCT: NCT06951633 · 29/RID/2025 · No. 022/ RID/SP/0027/2024/01