Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases
- Conditions
- TelerehabilitationFibrosing Interstitial Lung Disease
- Interventions
- Other: Hospital based outpatient exercise programOther: Synchronized online telerehabilitation exercise programOther: Videobased telerehabilitation exercise program
- Registration Number
- NCT05166057
- Lead Sponsor
- Saglik Bilimleri Universitesi
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 63
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard pulmonary rehabilitation group (SGr) Hospital based outpatient exercise program 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. Telerehabilitation Group (TG) Synchronized online 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. Video Group (VGr) Videobased telerehabilitation exercise program 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.
- Primary Outcome Measures
Name Time Method Dyspnea perception 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.
Exercise capacity 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.
Fatigue severity 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 Outcome Measures
Name Time Method Respiratory muscle strength 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.
Anxiety level 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%.
Physical activity level 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.
Quality of life level 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).
Depression level 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%.
Pulmonary function tests (PFTs) 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
Trial Locations
- Locations (1)
Esra Pehlivan
🇹🇷İstanbul, Üsküdar, Turkey