Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05190211

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
IPF	Other: Telerehabilitation exercise program Other: Videobased exercise program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation Group (TG)	Other: Telerehabilitation exercise program 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)	Other: Videobased exercise program 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.

Arm

Intervention/Treatment

Experimental: Telerehabilitation Group (TG)

Other: Telerehabilitation exercise program

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)

Other: Videobased exercise program

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.

Outcome Measures

Primary Outcome Measures

The exercise capacity [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 Outcome Measures

Forced vital capacity (FVC) [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
Perception of dyspnea [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.
Respiratory muscle strength [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.
Peripheral muscle strength [Change from baseline peripheral muscle strength at 8 weeks]
Peripheral muscle strength will be assessed by the hand held dynamometer
Perception of general fatigue [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.
Saint George Respiratory Questionnaire (SGRQ) score [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)
Hospital anxiety and depression scale score [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.
International Physical Activity Questionnaire- short form [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.
Forced expiratory volume in one second (FEV1) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.