| CTRI Number |
CTRI/2022/03/041284 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Home-based care for pulmonary fibrosis |
|
Scientific Title of Study
|
Effect of home-based pulmonary rehabilitation on pulmonary fibrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmita Saha |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College, Mangalore ,MAHE . |
| Address |
Physiotherapy Department, KMC, Center of Basic Sciences,Bejai,Mangalore-575004,Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8837049476 |
| Fax |
|
| Email |
saharashmita200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore ,MAHE, Department Of Physiotherapy |
| Address |
Physiotherapy Department, KMC, Center of Basic Sciences,Bejai,Mangalore-575004,Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8967035789 |
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore ,MAHE, Department Of Physiotherapy |
| Address |
Physiotherapy Department, KMC, Center of Basic Sciences,Bejai,Mangalore-575004,Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8967035789 |
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal Academy Of Higher EducationMAHEKMC |
| Address |
Triger Circle Road, Madhav Nagar,Manipal,Karnataka 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashmita saha |
KMC Jyothi ,KMC Attavar |
KMC Jyothi and KMC Attavar, Department of Physiotherapy(OPD), Mangalore
Dakshina Kannada
KARNATAKA |
8837049476
saharashmita200@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KMC, Mangalore |
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 |
| Intervention |
Home-Based Pulmonary Rehabilitation |
Warm-up/stretching:- Duration -5 min. and each stretch posture will be maintained for the 30s.
Frequency- 1-2 times per day for 8 weeks;
Aerobic exercise:- Duration:- 20-30 min.
Frequency:- 1-2 times per day for 8 weeks;
Strength training:- Time:- Time required for completing 2-3 sets of 8-10 reps.
Frequency:- 2 times/day for 8 weeks;
Resistance training:- Time:- Time required for completing 2-3 sets of 8-10 reps.
Frequency:- 2 times/day for 8 weeks;
Breathing exercises(Pursed lip breathing, diaphragmatic breathing, Thoracic expansion Exercise):-
Time:- 3 sets of 8-10 reps.
Frequency :- 3 times/day for 8weeks;
Incentive Spirometry:- Time:- 3 sets of 8-10 reps.
Frequency :- 3 times/day for 8weeks;
Controlled coughing exercises :-Time:- 2-3 sets of 8-10 reps.
Frequency :- 2-3 times/day for 8weeks;
Relaxation training:-Time:- 2 sets of 2-3 reps.
Frequency :- 2-3 times /day for 8weeks. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Pulmonary Fibrosis secondary to interstitial Lung Disease(ILD).
2. Pulmonary Fibrosis Post COVID.
3. Moderate to severe diagnosed through PFT(FEV1<50)
4.Independent Ambulation. |
|
| ExclusionCriteria |
| Details |
1.Cardiac conditions(Moderate to severe) like coronary artery disease, congestive heart failure.
2. Respiratory condition like chronic obstructive pulmonary disease(COPD),asthma, lung cancer, sever pulmonary hypertension.
3.Other neuromuscular conditions affecting respiratory as well as physical function.
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary Function Test,
6-minute walk test,
|
Base line- (Pre-test)
(post-test)-after 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-36 Scores |
Base Line-(Pre-test)
(Post-test)-After 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/04/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In a nutshell, the objectives of this study are to assess and compare the effect of pulmonary rehabilitation on pulmonary function test(PFT), Rating of Perceived Exertion (RPE),6-minute walk test, and QOL of pulmonary fibrosis patients and to study the effect of home-based pulmonary rehabilitation on pulmonary fibrosis. The need for this study is no studies have been found in the published format as a benefit of home-care-based pulmonary rehabilitation on post-covid-19 pulmonary fibrosis or pulmonary fibrosis secondary to ILD condition in India. Study participants will be recruited from KMC hospital, Mangalore, who will be visiting the outpatient department(OPD) diagnosed with pulmonary fibrosis. This study will be a single group pre-test and post-test experimental study design. Subjects will be included based on the inclusion criteria. They will be screened for points mentioned in the exclusion criteria. Pre-testing will be done before starting the home-based pulmonary rehabilitation program and all outcomes(PFT, SF-36, and 6-minute walk test) will be recorded. The intervention will be started in the home of the candidate, and all the guidelines of the American Thoracic Society(ATS) for home-based pulmonary rehabilitation will be followed. The protocol will be terminated if any of the termination criteria are noticed. After 8 weeks later, a post-test will be conducted and readings will be recorded. Based on the pre-readings and post-readings, statistical analysis will be done. Details of the intervention:- Throughout the 8-week program, the patients will be instructed about the benefits and importance of adhering to a pulmonary rehabilitation program. The patient’s party who will be there in the hospital will be taught about the benefit of the program, and we will ask them to supervise the program at their home. Participants and Participant’s parties will be provided a catalog with detailed instructions for the exercise program. The patients and patients’ parties will be given a notebook or diary in which the patient will have to be marked after performing daily. The patients will be instructed to do all exercises at least six days a week in three sessions with ten repetitions each. If significant fatigue or shortness of breath, they will be advised to take a rest and to keep doing the exercises according to their fatigue tolerance level. The supervision of the program will be done by phone calls once a week and daily exercise queries.
1.Warm-up/stretching :- The warm-up will be ~ 5min. It will be composed of active upper and lower limb exercises. Stretching will be ~5min. Each stretch posture will be maintained for the 30s. 2. Aerobic exercises:- Aerobic exercises will consist of walking and slow jogging. The training intensity will be light(less than 5 on the modified Borg scale). Time will be at least 20-30 min. And the exercise frequency will be 1-2 times per day for 8 weeks. 3. Strength training:- Shoulder flexion, extension, abduction with 1/2kg weight cuff,8-10 rep. for each movement 2-3 sets,2 times/day for 8weeks.Lower limb strengthening exercises and Sit to stand exercise 3 sets,10 reps. 2 times/day for 8 weeks. 4. Resistance training:- Exercise will be performed using both limbs simultaneously and an elastic band(TheraBand).3 sets of 8-10 reps. each with 1 min. of rest between sets will be performed for quadriceps, hamstrings, deltoids, and biceps brachii. 5. Others:- It consists of teaching breath control(pursed-lip breathing, diaphragmatic breathing), thoracic expansion exercise 10 reps,2-3 sets/day for 8 weeks, energy-saving techniques, Incentive spirometry, and controlled coughing exercises. Coping strategies to deal with shortness of breath and relaxation training will be taught to the patients.
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