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Clinical Trials/NCT05190211
NCT05190211
Recruiting
Not Applicable

The Effectiveness of Synchronized Online and Video-based Exercise Programs in Patients With Idiopathic Pulmonary Fibrosis

Istanbul Medipol University Hospital1 site in 1 country44 target enrollmentNovember 26, 2021
ConditionsIPF

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
IPF
Sponsor
Istanbul Medipol University Hospital
Enrollment
44
Locations
1
Primary Endpoint
The exercise capacity
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

It is to determine the effectiveness of different telerehabilitation exercise programs received to 2 groups randomly formed in idiopathic pulmonary fibrosis (IPF) patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr).

Detailed Description

Patients diagnosed with idiopathic pulmonary fibrosis by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr). TGr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the VGr group, after 1 session of online simultaneous exercise training in the company of a physiotherapist via videoconference on the smart phone, an exercise video including the exercises will be sent to them and the patients will be asked to do their exercises 3 days a week. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling them once a week. The exercise period will be 8 weeks for both groups.

Registry
clinicaltrials.gov
Start Date
November 26, 2021
End Date
August 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

esra pehlivan

Principal investigator

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • Being between the ages of 18-75
  • Having a diagnosis of IPF disease diagnosed according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS)
  • Presence of dyspnea on exertion
  • Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks

Exclusion Criteria

  • Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
  • A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
  • Participation in a pulmonary rehabilitation program within the past 12 months.

Outcomes

Primary Outcomes

The exercise capacity

Time Frame: Change from baseline 6 minute walking distance at 8 weeks

The exercise capacity will be assessed by the 6 minute walking test.The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines.

Secondary Outcomes

  • Perception of general fatigue(Change from baseline perception of general fatigue at 8 weeks)
  • Forced vital capacity (FVC)(Change from baseline FVC at 8 weeks)
  • Perception of dyspnea(Change from baseline dyspnea perception at 8 weeks)
  • Respiratory muscle strength(Change from baseline respiratory muscle strength at 8 weeks)
  • Forced expiratory volume in one second (FEV1)(Change from baseline FEV1 at 8 weeks)
  • International Physical Activity Questionnaire- short form(Change from baseline physical activity level at 8 weeks)
  • Peripheral muscle strength(Change from baseline peripheral muscle strength at 8 weeks)
  • Saint George Respiratory Questionnaire (SGRQ) score(Change from baseline SGRQ score at 8 weeks)
  • Hospital anxiety and depression scale score(Change from baseline anxiety level at 8 weeks)

Study Sites (1)

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