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

U

University School of Physical Education, Krakow, Poland

Status

Enrolling

Conditions

the Elderly
Respiratory Disorders

Treatments

Other: Subterranean, pulmonary rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06951633
No. 022/ RID/SP/0027/2024/01 (Other Grant/Funding Number)
29/RID/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Subterranean, pulmonary rehabilitation
Other group
Description:
Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort
Treatment:
Other: Subterranean, pulmonary rehabilitation

Trial contacts and locations

1

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Central trial contact

Sylwia Mętel, PhD; Magdalena Kostrzon, PhD

Data sourced from clinicaltrials.gov

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