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Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05166057
Enrollment
63
Registered
2021-12-21
Start date
2022-01-22
Completion date
2025-05-30
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosing Interstitial Lung Disease, Telerehabilitation

Keywords

fibrosing interstitial lung disease, telerehabilitation, physiotherapy, pulmonary rehabilitation

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.

Interventions

OTHERSynchronized online telerehabilitation exercise program

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

OTHERVideobased telerehabilitation exercise program

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.

OTHERHospital based outpatient exercise program

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

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Exercise capacityChange from baseline at 2 monthsThe 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 perceptionChange from baseline at 2 monthsmodified 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 severityChange from baseline at 2 monthsThe 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

MeasureTime frameDescription
Depression levelChange from baseline at 2 monthsHospital 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%.
Respiratory muscle strengthChange from baseline at 2 monthsThe 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.
Pulmonary function tests (PFTs)Change from baseline at 2 monthsPFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Quality of life levelChange from baseline at 2 monthsSaint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Physical activity levelChange from baseline at 2 monthsThe 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 levelChange from baseline at 2 monthsHospital 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%.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026