Interstitial Lung Diseases
Conditions
Brief summary
Pulmonary rehabilitation (PR) is a comprehensive, multidisciplinary intervention incorporating exercise training, education, and behavior change, shown to improve dyspnea, exercise capacity, and health-related quality of life (HRQoL) in ILD patients. However, access to center-based PR is limited in many settings, including ours, due to geographic, logistical, and socioeconomic barriers. Home-based pulmonary rehabilitation (HPR) may offer a scalable, accessible alternative with comparable outcomes to conventional PR. The drawback of HPR is the lack of monitoring, which may be overcome by incorporating a telemonitoring program to improve adherence. Data on the effectiveness of HPR in ILD populations-especially in resource-limited settings-are scarce. Therefore, this study aims to evaluate the impact of a 6-week home-based PR program on HRQoL and exercise capacity in patients with fibrotic ILD in India. The study hypothesis is that participants undergoing HPR will demonstrate clinically meaningful improvements in disease-specific HRQoL and six-minute walk distance compared to those receiving usual care.
Interventions
A standard exercise regimen will be taught to the subject at the randomization visit. The exercise regimen will be tailored only if the standard set cannot be followed by the subject and the individualized regimen will be recorded. The subject will be asked to complete a daily diary of activities. A telephonic follow up will be done every week for 8 weeks.
The standard of care pharmacologic treatment will be continued along with a general advice on maintaining an active and healthy lifestyle.
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years 2. Diagnosis of an ILD by clinician using standard guidelines 3. Having breathlessness graded 1 to 3 on the modified Research Council (mMRC) scale 4. On stable therapy with immunosuppressants or antifibrotics for 3 or more months
Exclusion criteria
1. Pregnant or lactating women 2. Unwilling to participate in the study 3. Not able to walk or perform upper and lower limb movements 4. Requiring supplemental oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the ILD health-related quality-of-life assessed using the King's Brief ILD questionnaire score | 8 weeks | King's-Brief Interstitial Lung Disease questionnaire: It is a validated brief health status questionnaire developed especially for patients with ILD. It contains 15 questions that evaluates the health status of patients in three different domains- breathlessness and activities, psychological and chest symptoms. The patient's responses are measured and finally expressed on a scale of 0-100 based on individual responses in each domain. Total and domain scores range from 0 to 100, where higher scores indicate better health-related quality of life. The minimal clinically important difference is 5 points. It will be completed by the study subjects at baseline and 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dypnoea | 8 weeks | Change in dyspnea will be assessed on modified Medical Research Council \[mMRC\] scale at the end of 8 weeks from randomization. The mMRC scale score ranges from 0 to 4, where higher scores |
| Change in six-minute walk distance | 8 weeks | Mean change in six-minute walk distance will be compared between the study groups at the end of 8 weeks from randomization. Six-minute walk test (6MWT) will be performed using American Thoracic Society guidelines |
| Change in quality-of-life assessed by the EQ-5D-5L score | 8 weeks | Mean change in EQ-5D-5L score will be compared between the study groups at the end of 8 weeks from randomization. EuroQol-5D-5L (EQ-5D-5L) questionnaire is a widely used standardized instrument designed to measure generic health-related quality of life (HRQoL). It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. The responses are combined into a single health state index and complemented by a visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health). It is applicable across diseases and treatments and will be administered at baseline and 8 weeks. |
| Change in forced vital capacity | 8 weeks | Forced vital capacity will be assessed by spirometry. Spirometry will be performed according to the ATS/ERS guidelines using an ultrasonic flow sensor spirometer (NDD Medizintechnik AG, Zurich, Switzerland). |
| Number of adverse events | 8 weeks | Number of adverse events will be recorded and compared between study groups. These will include disease progression, acute exacerbation, hospitalization, respiratory failure, death, excessive breathlessness, oxygen desaturation, chest pain, chest tightness, palpitations, presyncope/syncope, dizziness, light-headedness, excessive fatigue, weakness, or headache during or after exercise, musculoskeletal pain or injury, including muscle strain, joint pain, back pain, tendon injury, or sprain, exercise-related falls or loss of balance, particularly during stair climbing, squats, heel raises, or unsupported activities, exacerbation of cough or wheeze during exercise, delayed post-exercise symptoms, such as prolonged fatigue, myalgia, or breathlessness persisting for several hours, exercise intolerance requiring reduction or interruption of the prescribed programme. |
Countries
India
Contacts
CONTACTSahajal Dhooria, MD, DM
Outcome results
None listed