Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis
Primary Purpose
IPF
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation exercise program
Videobased exercise program
Sponsored by
About this trial
This is an interventional treatment trial for IPF focused on measuring IPF, telerehabilitation, videobased rehabilitation, exercise, physical therapy, pulmonary rehabilitation
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.
Sites / Locations
- Yedikule Chest Disease HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Telerehabilitation Group (TG)
Video Group (VGr)
Arm Description
Outcomes
Primary Outcome Measures
The exercise capacity
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 Outcome Measures
Forced vital capacity (FVC)
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
Perception of dyspnea
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.
Respiratory muscle strength
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.
Peripheral muscle strength
Peripheral muscle strength will be assessed by the hand held dynamometer
Perception of general fatigue
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.
Saint George Respiratory Questionnaire (SGRQ) score
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)
Hospital anxiety and depression scale score
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.
International Physical Activity Questionnaire- short form
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.
Forced expiratory volume in one second (FEV1)
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
Full Information
NCT ID
NCT05190211
First Posted
November 26, 2021
Last Updated
September 27, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05190211
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IPF
Keywords
IPF, telerehabilitation, videobased rehabilitation, exercise, physical therapy, pulmonary rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation Group (TG)
Arm Type
Experimental
Arm Title
Video Group (VGr)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telerehabilitation exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Videobased exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
The exercise capacity
Description
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.
Time Frame
Change from baseline 6 minute walking distance at 8 weeks
Secondary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Description
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
Time Frame
Change from baseline FVC at 8 weeks
Title
Perception of dyspnea
Description
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.
Time Frame
Change from baseline dyspnea perception at 8 weeks
Title
Respiratory muscle strength
Description
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.
Time Frame
Change from baseline respiratory muscle strength at 8 weeks
Title
Peripheral muscle strength
Description
Peripheral muscle strength will be assessed by the hand held dynamometer
Time Frame
Change from baseline peripheral muscle strength at 8 weeks
Title
Perception of general fatigue
Description
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.
Time Frame
Change from baseline perception of general fatigue at 8 weeks
Title
Saint George Respiratory Questionnaire (SGRQ) score
Description
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)
Time Frame
Change from baseline SGRQ score at 8 weeks
Title
Hospital anxiety and depression scale score
Description
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.
Time Frame
Change from baseline anxiety level at 8 weeks
Title
International Physical Activity Questionnaire- short form
Description
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.
Time Frame
Change from baseline physical activity level at 8 weeks
Title
Forced expiratory volume in one second (FEV1)
Description
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
Time Frame
Change from baseline FEV1 at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esra Pehlivan, PhD
Phone
+905058527913
Email
fztesrakambur@yahoo.com
Phone
+902124090200
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis
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