NCT06372353

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 11, 2025

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

March 13, 2024

Last Update Submit

April 9, 2025

Conditions

Keywords

Idiopathic Pulmonary FibrosisBaduanjin ExerciseFunctional CapacityRespiratory Function TestsQuality of Life

Outcome Measures

Primary Outcomes (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

    Baseline of the study and 8 weeks after intervention

Secondary Outcomes (7)

  • Pulmonary Function Tests

    Baseline of the study and 8 weeks after intervention

  • Pulmonary Function Tests

    Baseline of the study and 8 weeks after intervention

  • Pulmonary Function Tests

    Baseline of the study and 8 weeks after intervention

  • Pulmonary Function Tests

    Baseline of the study and 8 weeks after intervention

  • Respiratory muscle strength

    Baseline of the study and 8 weeks after intervention

  • +2 more secondary outcomes

Study Arms (2)

intervention Group

EXPERIMENTAL

The subjects in the intervention group were given 24 sessions of supervised online Baduanjin exercise training

Other: Baduanjin Exercise

Control Group

NO INTERVENTION

Interventions

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

Also known as: exercise
intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University - Cerrahpaşa

Istanbul, Fatih, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31613151BACKGROUND
  • 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.

    PMID: 12186831BACKGROUND
  • 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.

    PMID: 5772056BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

April 18, 2024

Study Start

June 1, 2022

Primary Completion

May 24, 2023

Study Completion

June 6, 2023

Last Updated

April 11, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations