Clinical trial NCT06372353: The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis
Official title: The Effect Of Baduanjin Exercises On Functional Capacity, Respiratory Functions And Quality Of Life In Patients With Idiopathic Pulmonary Fibrosis: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Fibrosis, Idiopathic
Keywords: Idiopathic Pulmonary Fibrosis
Baduanjin Exercise
Functional Capacity
Respiratory Function Tests
Quality of Life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment method

Methods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period

Detailed description: Introduction and Objectives: Idiopathic Pulmonary Fibrosis (IPF) is a disease with a poor prognosis that causes fibrosis in the interstitial space of the lungs, characterized by shortness of breath and progressive deterioration in lung function. The main purpose of this randomized controlled study is to investigate the effectiveness of applying Baduanjin exercise training for 8 weeks, which has previously been shown to be effective in other patient groups, on respiratory functions (%FVC, FEV1, FEV1%), respiratory muscle strength (MIP and MEP) and quality of life (SGRQ) in patients with IPF. It is planned to be used as a new treatment method in this patient group. It is to offer an alternative in terms of the applicability of Baduanjin exercises.

Methods: Twenty eight volunteers were invited to the study. These patients were randomly divided into 2 groups. The subjects in the exercise group were given 24 sessions of supervised online Baduanjin exercise training, 3 days a week for 8 weeks, and the patients also did Baduanjin exercise 1 day a week at home unattended. The first evaluation, follow-up and final evaluation of the patients included in the control group were performed; In addition to their sociodemographic characteristics, functional exercise capacity, respiratory muscle strength and respiratory functions, quality of life were evaluated before and after treatment.

Keywords: Idiopathic Pulmonary Fibrosis, Baduanjin exercise, Functional capacity, Respiratory functions, Quality of Life

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with IPF according to international guideline criteria; Medical Research Council (mMRC) dyspnea score \< 5; being able to ambulate without using an assistive device; being between the ages of 18-75; being cooperative; a stable patient with no pulmonary exacerbation in the last 6 weeks; having no vision or hearing deficits; having the necessary internet and computer or telephone equipment to participate in the online exercise program.

Exclusion Criteria:

* Participation in a formal rehabilitation program no later than 4 months before the beginning of the study; having severe musculoskeletal or neurological disorders; having severe heart disease; inability to understand informed consent conditions and exercises; need for additional oxygen at rest; presence of obvious lung infection requiring anti-infection therapy (patients had a respiratory tract infection or systemic infection within 4 weeks before enrollment); situations where exercise is contraindicated; presence of another chronic lung disease (e.g., collagen vascular disease, obstructive pulmonary disease, nonparenchymal restrictive lung disease, occupational lung disease, sarcoidosis, or other idiopathic interstitial pneumonia)

Primary outcomes:
measure: Functional capacity
timeFrame: Baseline of the study and 8 weeks after intervention
Secondary outcomes:
measure: Pulmonary Function Tests
timeFrame: Baseline of the study and 8 weeks after intervention
measure: Pulmonary Function Tests
timeFrame: Baseline of the study and 8 weeks after intervention
measure: Pulmonary Function Tests
timeFrame: Baseline of the study and 8 weeks after intervention
measure: Pulmonary Function Tests
timeFrame: Baseline of the study and 8 weeks after intervention
measure: Respiratory muscle strength
timeFrame: Baseline of the study and 8 weeks after intervention
measure: Respiratory muscle strength
timeFrame: Baseline of the study and 8 weeks after intervention
measure: St. George's Respiratory Questionnaire
timeFrame: Baseline of the study and 8 weeks after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University - Cerrahpaşa
state: Fatih
Study officials:
References:
citation: Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
citation: Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.