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Completed

NCT Number: NCT05166057

Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

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.

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Key information

Conditions

Fibrosing Interstitial Lung Disease Telerehabilitation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synchronized online telerehabilitation exercise program

Other

Breathing exercises, inspiratory muscle training, peripheral muscle strengthening training and gait training will be applied to the patient by videoconference.

Videobased telerehabilitation exercise program

Other

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.

Hospital based outpatient exercise program

Other

Breathing exercises, inspiratory muscle training, peripheral muscle strengthening training and gait training will be applied to the patient in the hospital..

Primary outcomes

  1. Exercise capacity

    Time frame: Change from baseline at 2 months

    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.

  2. Dyspnea perception

    Time frame: Change from baseline at 2 months

    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.

  3. Fatigue severity

    Time frame: Change from baseline at 2 months

    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 outcomes

  1. Respiratory muscle strength

    Time frame: Change from baseline at 2 months

    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.

  2. Physical activity level

    Time frame: Change from baseline at 2 months

    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.

  3. Anxiety level

    Time frame: Change from baseline at 2 months

    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%.

  4. Depression level

    Time frame: Change from baseline at 2 months

    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%.

  5. Quality of life level

    Time frame: Change from baseline at 2 months

    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).

  6. Pulmonary function tests (PFTs)

    Time frame: Change from baseline at 2 months

    PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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