| CTRI Number |
CTRI/2024/06/069671 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intervention including breathing exercises and limb exercises] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of breathing and limb exercises based rehabilitation on sleep quality and physical activity among patients with chronic lung Disease |
|
Scientific Title of Study
|
Effectiveness of pulmonary rehabilitation based interventional package on quality of sleep and functional status among patients with Chronic Obstructive Pulmonary 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 |
Preemy Mathew A |
| Designation |
Associate Professor |
| Affiliation |
GOVERNMENT COLLEGE OF NURSING ALAPPUZHA |
| Address |
GOVERNMENT College of Nursing
Department Of Medical Surgical Nursing
Alappuzha
KERALA
PIN -688005
KERALA
GOVERNMENT COLLEGE OF NURSING
ALAPPUZHA
KERALA
PIN CODE 688005
Alappuzha
KERALA
688005
India |
| Phone |
9072118972 |
| Fax |
- |
| Email |
preemygeorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lucyamma Joseph |
| Designation |
Principal |
| Affiliation |
Goverment College of Nursing ParippallyNURSING |
| Address |
Principal
Government College of Nursing
Parippally
Kollam
Kerala
PIN CODE695588
Principal
Government College Of Nursing
Parippally
Kollam
Kerala
PIN CODE695
Thiruvananthapuram
KERALA
695588
India |
| Phone |
9446550897 |
| Fax |
- |
| Email |
drlucyamma50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lucyamma Joseph |
| Designation |
Principal |
| Affiliation |
College Of Nursing Parippally |
| Address |
Principal
Government College Of Nursing
Parippally
Kollam
Kerala
Pin Code -695588
Principal
Government College Of Nursing
Parippally
Kollam
Kerala
PIN CODE695
Thiruvananthapuram
KERALA
695588
India |
| Phone |
9446550897 |
| Fax |
- |
| Email |
drlucyamma50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thirumala Devaswam Medical College Hospital[T.D Medical college Hospital]
Alappuzha
Kerala
India
Pin code-688005
|
|
|
Primary Sponsor
|
| Name |
Preemy Mathew A |
| Address |
Associate Professor
Goverment College Of Nursing
Alappuzha
Kerala
India
Pin cod-688005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrPreemy Mathew A |
GovermentT.D Medical College Hospital Alappuzha |
Department Of Pulmonary Medicine
Ground Floor
Room no 7
ALAPPUZHA
Alappuzha
KERALA |
9072118972
preemygeorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Government college of Nursing Alappuzha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group is patient with COPD receiving routine care and treatment of COPD |
Patient with COPD MORE THAN 40 YEARS AND LESS THAN 75 YEARS |
| Intervention |
Pulmonary rehabilitation based interventional package |
pulmonary rehabilitation based interventions includes educational session and demonstration on use of inhaler , breathing exercises and limb exercises for a period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
age more than 40 years and less than 75 years |
|
| ExclusionCriteria |
| Details |
clinical diagnosis of malignancy of lung,interstitial lung disease,decompensated heart and renal failure
prior cardiac or lung resection surgery |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional status |
measurement of functional status at 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measurement of Quality of sleep |
fourth week & eight week |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="2"
Days="10" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response - None of the above
Response (Others) -
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [preemygeorge@gmail.com].
- For how long will this data be available start date provided 15-12-2025 and end date provided 15-09-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study is a randomized control trial using allocation concealment and blindIing of outcome measurement sampling is block randomization of size 4 The purpose of study is to evaluate the effectiveness of interventional package on quality of sleep and functional status among patients with COPD Hypothesis of study 1. There will be a significant difference in the scores of quality of sleep between control and experimental group among patients with COPD 2.There will significant difference in the scores of functional status between control and experimental group amonggptients with COPD |