- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190211
Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis
September 27, 2023 updated by: ESRA PEHLIVAN, Istanbul Medipol University Hospital
The Effectiveness of Synchronized Online and Video-based Exercise Programs in Patients With Idiopathic Pulmonary Fibrosis
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34200
- Recruiting
- Yedikule Chest Disease Hospital
-
Contact:
- Esra Pehlivan, PhD
- Phone Number: +905058527913
- Email: fztesrakambur@yahoo.com
-
Contact:
- Phone Number: +902124090200
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telerehabilitation Group (TG)
|
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.
|
Experimental: Video Group (VGr)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline 6 minute walking distance at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced vital capacity (FVC)
Time Frame: Change from baseline FVC at 8 weeks
|
Forced vital capacity will be assessed by the spirometer.
Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
|
Change from baseline FVC at 8 weeks
|
Perception of dyspnea
Time Frame: Change from baseline dyspnea perception at 8 weeks
|
Perception of dyspnea will be evaluated by Modified Medical Research Council Dyspnea scale.
The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.
|
Change from baseline dyspnea perception at 8 weeks
|
Respiratory muscle strength
Time Frame: Change from baseline respiratory muscle strength at 8 weeks
|
Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.The mouth pressure measurement was performed with the Cosmed Pony Fx.
Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible.
The patient was allowed to rest for about a minute and the maneuver was repeated five times.
Verbal or visual feedback was provided after each maneuver.
The aim is that the variability between measurements is less than 10 cm H2O.
The maximum value was obtained.
|
Change from baseline respiratory muscle strength at 8 weeks
|
Peripheral muscle strength
Time Frame: Change from baseline peripheral muscle strength at 8 weeks
|
Peripheral muscle strength will be assessed by the hand held dynamometer
|
Change from baseline peripheral muscle strength at 8 weeks
|
Perception of general fatigue
Time Frame: Change from baseline perception of general fatigue at 8 weeks
|
Perception of fatigue will be assessed by the Fatigue severity scale.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.
The minimum score = 9 and maximum score possible = 63.
Higher the score = greater fatigue severity.
Another way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7.
|
Change from baseline perception of general fatigue at 8 weeks
|
Saint George Respiratory Questionnaire (SGRQ) score
Time Frame: Change from baseline SGRQ score at 8 weeks
|
The quality of life will be assessed by the Saint George Respiratory Questionnaire.The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
|
Change from baseline SGRQ score at 8 weeks
|
Hospital anxiety and depression scale score
Time Frame: Change from baseline anxiety level at 8 weeks
|
The anxiety levels will be evaluated by Hospital anxiety and depression scale.The total score ranges from 0-63.
The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.
|
Change from baseline anxiety level at 8 weeks
|
International Physical Activity Questionnaire- short form
Time Frame: Change from baseline physical activity level at 8 weeks
|
Physical activity level will be assessed by International Physical Activity Questionnaire- Short form.
Including seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week.MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking ëdaysí Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.
|
Change from baseline physical activity level at 8 weeks
|
Forced expiratory volume in one second (FEV1)
Time Frame: Change from baseline FEV1 at 8 weeks
|
Forced expiratory volume in one second will be assessed by the spirometer.
Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
|
Change from baseline FEV1 at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 26, 2021
First Submitted That Met QC Criteria
December 28, 2021
First Posted (Actual)
January 13, 2022
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPFTele
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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