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Pulmonary Fibrosis, IdiopathicNCT06372353

The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis

A study testing Baduanjin Exercise in people with Pulmonary Fibrosis, Idiopathic, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Fibrosis, Idiopathic
What is being tested?
Baduanjin Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2022to 6 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İstanbul University - Cerrahpaşa

    Istanbul, Fatih

Other trials in Turkey (Türkiye)

About this study

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

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

Read the 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

Being tested
Baduanjin Exercise
Keywords
Idiopathic Pulmonary Fibrosis, Baduanjin Exercise, Functional Capacity, Respiratory Function Tests, Quality of Life
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baduanjin ExerciseOther

    Also called exercise

    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

Study groups in NCT06372353
Study groupRoleWhat they receive
intervention GroupExperimentalThe subjects in the intervention group were given 24 sessions of supervised online Baduanjin exercise training
Receives: Other: Baduanjin Exercise
Control GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional capacity

    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

    Measured: Baseline of the study and 8 weeks after intervention

Secondary outcomes (7)

  1. Pulmonary Function Tests

    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).

    Measured: Baseline of the study and 8 weeks after intervention

  2. Pulmonary Function Tests

    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).

    Measured: Baseline of the study and 8 weeks after intervention

  3. Pulmonary Function Tests

    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).

    Measured: Baseline of the study and 8 weeks after intervention

  4. Pulmonary Function Tests

    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).

    Measured: Baseline of the study and 8 weeks after intervention

  5. Respiratory muscle strength

    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.

    Measured: Baseline of the study and 8 weeks after intervention

  6. Respiratory muscle strength

    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.

    Measured: Baseline of the study and 8 weeks after intervention

  7. St. George's Respiratory Questionnaire

    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.

    Measured: Baseline of the study and 8 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start1 Jun 2022
  3. Primary completion24 May 2023
  4. Study completion6 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372353
Sponsor's protocol ID
777
Status last verified
Feb 2024
First submitted
13 Mar 2024
Last updated
11 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31613151

  • 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.

    PubMed 12186831

  • 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.

    PubMed 5772056

  • Atmaca SN, Demir R, Mustafaoglu R, Atahan E. The effect of Baduanjin exercises on the functional capacity, respiratory function, and quality of life of patients with idiopathic pulmonary fibrosis: a randomized controlled trial. Biopsychosoc Med. 2025 Nov 3;19(1):24. doi: 10.1186/s13030-025-00346-8.

    PubMed 41184899

Questions about this trial

What is this clinical trial studying?

A study testing Baduanjin Exercise in people with Pulmonary Fibrosis, Idiopathic, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity (time frame: Baseline of the study and 8 weeks after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372353, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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