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Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

Primary Purpose

Fibrosing Interstitial Lung Disease, Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synchronized online telerehabilitation exercise program
Videobased telerehabilitation exercise program
Hospital based outpatient exercise program
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrosing Interstitial Lung Disease focused on measuring fibrosing interstitial lung disease, telerehabilitation, physiotherapy, pulmonary rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being between the ages of 18-75
  • Have a diagnosis of fibrosing interstitial lung disease diagnosed according to the clinical diagnostic criteria of 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
  • Ability to use a smart phone

Exclusion Criteria:

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

Sites / Locations

  • Esra PehlivanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Telerehabilitation Group (TG)

Video Group (VGr)

Standard pulmonary rehabilitation group (SGr)

Arm 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.

After 1 session of online simultaneous exercise training in the company of a physiotherapist via a smart phone videoconference to the VGr group, an exercise video including the exercises will be sent and the participants will be asked to do exercises 3 days a week. The cases will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.

The SGr group will be applied the pulmonary rehabilitation program with supervision in the hospital 2 days a week, and participants will be asked to do exercises at home for 1 day. The exercise period will be 8 weeks for both groups.

Outcomes

Primary Outcome Measures

Exercise capacity
The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.
Dyspnea perception
modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Fatigue severity
The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. 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 Self-report scale

Secondary Outcome Measures

Respiratory muscle strength
The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.
Physical activity level
The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Anxiety level
Hospital Anxiety Depression scale:The levels of anxiety will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Depression level
Hospital Anxiety Depression scale:The levels of depression will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Quality of life level
Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Pulmonary function tests (PFTs)
PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines

Full Information

First Posted
December 8, 2021
Last Updated
May 12, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05166057
Brief Title
Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases
Official Title
Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

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
The aim of the study is to determine the effectiveness of different exercise programs applied to 3 groups randomly formed in patients with fibrosing interstitial lung disease (FILD). Secondary purpose: To determine the feasibility and effectiveness of telerehabilitation in FILD cases.
Detailed Description
The cases meeting the inclusion criteria will be randomized and divided into three groups, the groups will be named as Telerehabilitation Exercise Group (TGr), Video Group (VGr) and Standard pulmonary rehabilitation group (SGr).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.After 1 session of online simultaneous exercise training in the company of a physiotherapist via a smart phone videoconference to the VGr group, an exercise video including the exercises will be sent to participants and the patients will be asked to do exercises 3 days a week. The participants will be asked to keep an exercise diary and the status of the diaries will be followed by phone call once a week.The SGr group will be applied the pulmonary rehabilitation program with supervision in the hospital 2 days a week, and participants will be asked to do exercises at home for 1 day. The exercise period will be 8 weeks for both groups.Details of the exercises to be applied to the cases are as follows: The exercise program includes aerobic, resistance exercises and breathing exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosing Interstitial Lung Disease, Telerehabilitation
Keywords
fibrosing interstitial lung disease, telerehabilitation, physiotherapy, 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 three groups, the groups will be named as Telerehabilitation Exercise Group (TGr), Video Group (VGr) and Standard pulmonary rehabilitation group (SGr).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group (TG)
Arm Type
Experimental
Arm 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.
Arm Title
Video Group (VGr)
Arm Type
Experimental
Arm Description
After 1 session of online simultaneous exercise training in the company of a physiotherapist via a smart phone videoconference to the VGr group, an exercise video including the exercises will be sent and the participants will be asked to do exercises 3 days a week. The cases will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.
Arm Title
Standard pulmonary rehabilitation group (SGr)
Arm Type
Experimental
Arm Description
The SGr group will be applied the pulmonary rehabilitation program with supervision in the hospital 2 days a week, and participants will be asked to do exercises at home for 1 day. The exercise period will be 8 weeks for both groups.
Intervention Type
Other
Intervention Name(s)
Synchronized online telerehabilitation exercise program
Intervention Description
Breathing exercises, inspiratory muscle training, peripheral muscle strengthening training and gait training will be applied to the patient by videoconference.
Intervention Type
Other
Intervention Name(s)
Videobased telerehabilitation exercise program
Intervention Description
A video containing breathing exercises, inspiratory muscle training, peripheral muscle strengthening training and gait training will be given to the patient and will be asked to exercise regularly.
Intervention Type
Other
Intervention Name(s)
Hospital based outpatient exercise program
Intervention Description
Breathing exercises, inspiratory muscle training, peripheral muscle strengthening training and gait training will be applied to the patient in the hospital..
Primary Outcome Measure Information:
Title
Exercise capacity
Description
The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.
Time Frame
Change from baseline at 2 months
Title
Dyspnea perception
Description
modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Time Frame
Change from baseline at 2 months
Title
Fatigue severity
Description
The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. 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 Self-report scale
Time Frame
Change from baseline at 2 months
Secondary Outcome Measure Information:
Title
Respiratory muscle strength
Description
The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.
Time Frame
Change from baseline at 2 months
Title
Physical activity level
Description
The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Time Frame
Change from baseline at 2 months
Title
Anxiety level
Description
Hospital Anxiety Depression scale:The levels of anxiety will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Time Frame
Change from baseline at 2 months
Title
Depression level
Description
Hospital Anxiety Depression scale:The levels of depression will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Time Frame
Change from baseline at 2 months
Title
Quality of life level
Description
Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Time Frame
Change from baseline at 2 months
Title
Pulmonary function tests (PFTs)
Description
PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Time Frame
Change from baseline at 2 months

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 Have a diagnosis of fibrosing interstitial lung disease diagnosed according to the clinical diagnostic criteria of 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 Ability to use a smart phone Exclusion Criteria: Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min). history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training. Participating in a pulmonary rehabilitation program within the past 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ESRA PEHLİVAN, Assoc.Prof.
Phone
02164189616
Email
fztesrakambur@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra PEHLİVAN, PT
Phone
02164189616
Email
fztesrakambur@yahoo.com
Facility Information:
Facility Name
Esra Pehlivan
City
İstanbul
State/Province
Üsküdar
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ESRA PEHLİVAN
Phone
02164189616
Email
fztesrakambur@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

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