CTRI/2025/03/081883Not yet recruitingNot Applicable
Efficacy of a novel exercise protocol in improving outcomes for patients with chronic respiratory disease
Ankita Samuel1 site in 1 country63 target enrollmentStarted: March 17, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- PFT-TLC,FVC,MVV
Study Overview
Brief Summary
Chronic respiratory diseases (CRDs) like COPD and asthma affect millions globally, causing significant disability and premature death.
1 Pulmonary rehabilitation (PR) improves quality of life but access is limited. 2 Telerehabilitation offers a promising alternative. This study aims to assess the feasibility and effectiveness of a home-based PR program in Delhi NCR.
Aims:
- Determine CRD prevalence in Delhi NCR.
- Develop a home-based exercise protocol for PR.
Objectives:
- Identify CRD prevalence and distribution in Delhi NCR.
- Evaluate internet connectivity and technology usability among CRD patients.
- Review existing home-based physiotherapy programs.
- Customize exercise protocols for home use.
- Assess integration of home-based program into healthcare systems.
- Measure patient adherence, satisfaction, and clinical improvements.
Inclusion Criteria:
- Age
30 years
- Diagnosed CRD
- On optimal medical treatment (excluding regular corticosteroids)
- Exacerbation history in last 1 year
- Informed consent
- English literacy
- Own and able to use a smartphone/tablet/computer
Exclusion Criteria:
- Conditions impairing exercise tolerance (orthopedic, neurological)
- Cognitive impairment/difficulty managing devices
- Domiciliary oxygen use
- Recent upper limb/thoracic surgery (<6 months)
Methods: (Details not provided in excerpt)
Outcome Measures:
- Pulmonary Function Tests (TLC, FVC)
- Chronic Respiratory Questionnaire (CRQ)
- Patient Satisfaction Questionnaire (PSQ-18)
- 6-Minute Walk Test (6MWT)
- MRC Dyspnea Scale
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed Chronic Respiratory illness
- •On Optimal medical treatment without regular use of Corticosteroids
- •History of exacerbation in last 1 year
- •Able to read and write in English 5.
Exclusion Criteria
- •Diagnosis of Orthopedic, Neurological and other conditions impairing exercise tolerance
- •Cognitive impairment and/or difficulty to manage electronic devices
- •Use of Domiciliary Oxygen
- •Recent upper limb/ thoracic surgery in past 6 months.
Outcomes
Primary Outcomes
PFT-TLC,FVC,MVV
Time Frame: Base line and end of 6 weeks
Chronic respiratory questionnaire
Time Frame: Base line and end of 6 weeks
Patient satisfaction questionnaire
Time Frame: Base line and end of 6 weeks
^minutes walk test
Time Frame: Base line and end of 6 weeks
Secondary Outcomes
- MRC- dyspnoea will be noted during the day of intervention(3 times in a week for 6 weeks)
Investigators
Ankita Samuel
S G T University
Study Sites (1)
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