Clinical trial NCT05190211: Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis
Official title: The Effectiveness of Synchronized Online and Video-based Exercise Programs in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IPF
Keywords: IPF
telerehabilitation
videobased rehabilitation
exercise
physical therapy
pulmonary rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The exercise capacity
timeFrame: Change from baseline 6 minute walking distance at 8 weeks
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: Change from baseline FVC at 8 weeks
measure: Perception of dyspnea
timeFrame: Change from baseline dyspnea perception at 8 weeks
measure: Respiratory muscle strength
timeFrame: Change from baseline respiratory muscle strength at 8 weeks
measure: Peripheral muscle strength
timeFrame: Change from baseline peripheral muscle strength at 8 weeks
measure: Perception of general fatigue
timeFrame: Change from baseline perception of general fatigue at 8 weeks
measure: Saint George Respiratory Questionnaire (SGRQ) score
timeFrame: Change from baseline SGRQ score at 8 weeks
measure: Hospital anxiety and depression scale score
timeFrame: Change from baseline anxiety level at 8 weeks
measure: International Physical Activity Questionnaire- short form
timeFrame: Change from baseline physical activity level at 8 weeks
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Change from baseline FEV1 at 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
References: