Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 9:48 PM
Study NCT ID:
NCT06951633
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.
Sponsor:
University School of Physical Education, Krakow, Poland
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRSC-FERPBR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No. 022/ RID/SP/0027/2024/01 | OTHER_GRANT | Minister of Science and Higher Education | View |