Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

NCT05166057 | Completed

• 1 other identifier: FLD_Tele
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosing Interstitial Lung Disease; Telerehabilitation

Keywords

fibrosing interstitial lung disease; telerehabilitation; physiotherapy; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from baseline at 2 months

• 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.

  Change from baseline at 2 months

• 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

  Change from baseline at 2 months

Secondary Outcomes (6)

• Respiratory muscle strength

  Change from baseline at 2 months

• Physical activity level

  Change from baseline at 2 months

• Anxiety level

  Change from baseline at 2 months

• Depression level

  Change from baseline at 2 months

• Quality of life level

  Change from baseline at 2 months

Study Arms (3)

Telerehabilitation Group (TG)

EXPERIMENTAL

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.

Other: Synchronized online telerehabilitation exercise program

Video Group (VGr)

EXPERIMENTAL

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.

Other: Videobased telerehabilitation exercise program

Standard pulmonary rehabilitation group (SGr)

EXPERIMENTAL

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.

Other: Hospital based outpatient exercise program

Interventions

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.

Telerehabilitation Group (TG)

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.

Video Group (VGr)

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..

Standard pulmonary rehabilitation group (SGr)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• Pehlivan E, Cetinkaya E, Karaahmetoglu FS, Ozcan ZB, Baydili KN, Demirkol B, Cinarka H, Eren R, Atac A. The impact of different pulmonary rehabilitation approaches on fibrotic interstitial lung disease: a comparative randomized trial. Expert Rev Respir Med. 2025 Sep;19(9):1027-1035. doi: 10.1080/17476348.2025.2513512. Epub 2025 May 29.

  PMID: 40440705 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 22, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

TU (1)