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Completed

NCT Number: NCT06372353

The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis

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

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Key information

Conditions

Pulmonary Fibrosis, Idiopathic Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul University - Cerrahpaşa

Istanbul, Fatih, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Baduanjin Exercise

Other

Baduanjin exercise training program was applied to the subjects in the exercise group, 3 days a week, 5 minutes each with warm-up and cool-down exercises, for a total of 24 sessions, 60 minutes each, under supervision, online, via the ZOOM application, for 8 weeks. In addition, the patients did the exercises unsupervised at home once a week. The patients' first sessions were held in the hospital

Other names: exercise

Primary outcomes

  1. Functional capacity

    Time frame: Baseline of the study and 8 weeks after intervention

    Functional exercise capacity was evaluated with the six-minute walking test (6MWT). Participants rested in a sitting position for 10 minutes before starting the test. Participants were then explained the test protocol and asked to walk as far as possible without running in a 30-meter straight corridor for six minutes. At the end of the test, the evaluations made before the test were repeated and the six-minute walking distance (6MWD) was recorded in meters

Secondary outcomes

  1. Pulmonary Function Tests

    Time frame: Baseline of the study and 8 weeks after intervention

    Pulmonary function tests were performed using standard references. Portable spirometry (Spirobank II; MIR, Rome, Italy) was utilized to assess pulmonary functions. The assessments adhered to the standards outlined by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines, with measurements expressed as percentages of predicted values. The following parameters related to pulmonary function were measured: Forced expiratory volume in 1 second (FEV1).

  2. Pulmonary Function Tests

    Time frame: Baseline of the study and 8 weeks after intervention

    Pulmonary function tests were performed using standard references. Portable spirometry (Spirobank II; MIR, Rome, Italy) was utilized to assess pulmonary functions. The assessments adhered to the standards outlined by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines, with measurements expressed as percentages of predicted values. The following parameters related to pulmonary function were measured: Forced vital capacity (FVC).

  3. Pulmonary Function Tests

    Time frame: Baseline of the study and 8 weeks after intervention

    Pulmonary function tests were performed using standard references. Portable spirometry (Spirobank II; MIR, Rome, Italy) was utilized to assess pulmonary functions. The assessments adhered to the standards outlined by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines, with measurements expressed as percentages of predicted values. The following parameters related to pulmonary function were measured: Peak expiratory flow (PEF).

  4. Pulmonary Function Tests

    Time frame: Baseline of the study and 8 weeks after intervention

    Pulmonary function tests were performed using standard references. Portable spirometry (Spirobank II; MIR, Rome, Italy) was utilized to assess pulmonary functions. The assessments adhered to the standards outlined by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) guidelines, with measurements expressed as percentages of predicted values. The following parameters related to pulmonary function were measured: Forced mid-expiratory flow (FEF).

  5. Respiratory muscle strength

    Time frame: Baseline of the study and 8 weeks after intervention

    Respiratory muscle strengths (intraoral pressure measurement) were performed using standard references. Maximal inspiratory pressures (MIP) were utilized to assess the strength of the respiratory muscles. Participants; MIP were measured and documented according to ATS/ERS criteria using a portable MicroRPM device (Micro Medical, Basingstoke, UK) . The highest of the at least three measurements exhibiting a difference between them of no more than 5 cm H2O is documented for MIP. Determination of predicted value for MIP was made according to the definitions put forward by Black and Hyatt.

  6. Respiratory muscle strength

    Time frame: Baseline of the study and 8 weeks after intervention

    Respiratory muscle strengths (intraoral pressure measurement) were performed using standard references. Maximal expiratory pressures (MEP) were utilized to assess the strength of the respiratory muscles. Participants; MEP were measured and documented according to ATS/ERS criteria using a portable MicroRPM device (Micro Medical, Basingstoke, UK) . The highest of the at least three measurements exhibiting a difference between them of no more than 5 cm H2O is documented for MEP. Determination of predicted value for MEP was made according to the definitions put forward by Black and Hyatt.

  7. St. George's Respiratory Questionnaire

    Time frame: Baseline of the study and 8 weeks after intervention

    Quality of life was measured with using Saint George Respiratory Questionaire (SGRQ), SGRQ, a 76-question form which includes dimensions for SGRQ activity, SGRQ impact, SGRQ symptoms, and SGRQ total. Scale (score 0-100, where 100 is the worst). All assessments were performed for the same patient at similar times of the day.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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