| CTRI Number |
CTRI/2025/03/081883 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exercise protocol for patients with chronic Respiratory diseases |
|
Scientific Title of Study
|
Efficacy of a novel exercise protocol in improving outcomes for patients with chronic respiratory disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Samuel |
| Designation |
PhD Scholar |
| Affiliation |
S G T University |
| Address |
Faculty of Physiotherapy,
SGT University,
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Faculty of Physiotherapy,
SGT University,
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9899687131 |
| Fax |
|
| Email |
ankitasamuel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja Bhati |
| Designation |
Assistant Professor |
| Affiliation |
S G T University |
| Address |
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8802192456 |
| Fax |
|
| Email |
pooja_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Samuel |
| Designation |
PhD Scholar |
| Affiliation |
S G T University |
| Address |
Faculty of Physiotherapy,
SGT University,
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA
122018
India |
| Phone |
9899687131 |
| Fax |
|
| Email |
ankitasamuel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,
SGT University,
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
Ankita Samuel |
| Address |
Room No. 307, B-block
K.R. Mangalam University
Sohna - Gurgaon Rd, Sohna,
Sohna Rural, Gurugram,
Haryana-122103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Bhati |
SGT Hospital |
Room no. LG-07, Block-D,Faculty of Physiotherapy,
SGT University,
Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505
Gurgaon
HARYANA |
8802192456
pooja_fphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J40-J47||Chronic lower respiratory diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
handout based exercise rehabilitation |
1 Pursed lip breathing 2 Diaphragmatic breathing 3 Segmental breathing 4 Biceps curls 5 Shoulder flexor strengthening 6 Scapular retraction 7 Thoracic rotation 8 Chair sit-to-stand 9 wall squats 10 Thoracic expansion exercises ( Box breathing) 11 walking |
| Intervention |
Supervised exercise rehabilitation |
The protocol comprises of the following-
1 Pursed lip breathing
2 Diaphragmatic breathing
3 Segmental breathing
4 Biceps curls
5 Shoulder flexor strengthening
6 Scapular retraction
7 Thoracic rotation
8 Chair sit-to-stand
9 wall squats
10 Thoracic expansion exercises ( Box breathing)
11 walking
Intervention will be done for 3 days in a week and for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed Chronic Respiratory illness
2. On Optimal medical treatment without regular use of Corticosteroids
3. History of exacerbation in last 1 year
4. Able to read and write in English
5. Own a smart phone?Tablet/ Desktop computer |
|
| ExclusionCriteria |
| Details |
1. Diagnosis of Orthopedic, Neurological and other conditions impairing exercise tolerance
2. Cognitive impairment and/or difficulty to manage electronic devices
3. Use of Domiciliary Oxygen
4. Recent upper limb/ thoracic surgery in past 6 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PFT-TLC,FVC,MVV
Chronic respiratory questionnaire
Patient satisfaction questionnaire
^minutes walk test |
Base line and end of 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MRC- dyspnoea will be noted during the day of intervention |
3 times in a week for 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|