| CTRI Number |
CTRI/2023/04/052038 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| 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
|
Combined Benefits of respiratory muscle training and endurance training program in interstitial lung disease |
|
Scientific Title of Study
|
Effect of inspiratory muscle training combined with whole-body endurance training program on balance in interstitial lung disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no.111, 1st floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
08587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no.111, 1st floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
08587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Aalina Khalil |
| Designation |
PG student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9103269134 |
| Fax |
|
| Email |
khalilaalina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
|
|
Primary Sponsor
|
| Name |
Centre for physiotherapy and rehabilitation sciences Jamia Millia Islamia |
| Address |
Jamia Millia Islamia, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adila Parveen |
Centre for Physiotherapy and Rehabilitation Sciences |
Jamia Millia Islamia, Jamia Nagar, Okhla, New Delhi
South
DELHI |
08587868142
aparveen1@jmi.ac.in |
| Aalina Khalil |
Metro Hospitals and Heart Institute |
Room no 13, Metro center for respiratory disease, L- 94, Sector 11, Noida- 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9103269134
khalilaalina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
| Metro Ethics Review Board, Metro Hospitals and Heart Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endurance Training(3 times per week for 3 weeks) |
This part of the training program will consist an aerobic supervised exercise training. The training will consists of 30-minutes of supervised treadmill exercise per session with three sessions a week. Each session will end with upper and lower limb stretching. Each participant will receive an individualized program based on 60% to 80% of the average speed achieved during the six minute walk test |
| Intervention |
Inspiratory muscle training with Endurance Training(3 times per week for 8 weeks) |
In the ET +IMT group participants will additionally receive 21 minutes of IMT on the same day following ET session,3 times for 8 weeks using a threshold inspiratory muscle trainer. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
•HRCT (High resolution Computed Tomography) diagnosed Interstitial lung disease
•Only patients with forced expiratory volume in 1 s (FEV1) <80% predicted.
•FEV1/forced vital capacity (FVC) <70% will be eligible to participate in the study.
•They will be between 45-75 years of age, and clinically stable.
|
|
| ExclusionCriteria |
| Details |
•Cardiovascular problems.
•Diagnosed psychiatric or cognitive disorders.
•Progressive neuromuscular diseases.
•Severe orthopedic problems with a significant impact on daily activities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale (BBS)
Timed Up and Go (TUG)
Single Leg Stance test (SLS)
Activities Balance Confidence scale (ABC) |
at baseline and after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum inspiratory pressure (PI max)
Six minute walk distance
Six minute distance percentage predictor |
at baseline and after 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
30/04/2023 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with documented ILD will be recruited from
Metro Centre for Respiratory Disease, Noida , UP, and will be informed about
the study. Subjects will be explained the purpose and methodology and possible
risks of the study. They will be given an informed consent form explaining
their rights as research subjects. They will be selected based on inclusion
criteria and exclusion criteria and divided into two groups: (experimental
group 1, G=23) and (Control group 2, G2=23). All identifying information on the
consent form and demographic history/ screening questionnaires will be kept
confidential. Before initial training, each patient will undergo a primary
health evaluation, PARQ (Physical Activity Readiness Questionnaire) and
interview (including complete pharmacological and family history). The initial
assessment will be done on first visit. It will include anthropometric
measures. Balance will be assessed by Berg Balance Scale (BBS), Timed Up and Go
(TUG), Single Leg Stance test (SLS) and Activities-specific Balance Confidence
(ABC) Scale. Besides Maximal inspiratory pressure and Six-minute walk test will
be assessed. Control group and experimental groups will be allowed to practice
their usual routines and medications. An 8-week pulmonary rehabilitation will
be given to both the groups, but the inspiratory muscle training (by IMT
Powerbreathe medic) will be addition only in the experimental group. The
study will be carried out in the Pulmonary Rehab of Metro Centre for
Respiratory Diseases, Noida, UP, India.
|