| CTRI Number |
CTRI/2024/03/063876 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Progressive Muscle Relaxation Technique on shortness of breath and tiredness in patients with Extrapulmonary Tuberculosis |
|
Scientific Title of Study
|
Effect of Progressive Muscle Relaxation Technique on Dyspnea and Fatigue in patients with Extrapulmonary Tuberculosis: A Quasi Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, physiotherapy OPD, Room number 510, Kumarhatti, Solan H.P. Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876472736 |
| Fax |
|
| Email |
neathakur17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, physiotherapy OPD, Room number 510, Kumarhatti, Solan H.P. Solan
Una
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
Drgeetanjalikaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar University, Orthopedics Department, physiotherapy OPD, Room number 510, Kumarhatti, Solan H.P. Solan
Una
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
Drgeetanjalikaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
|
|
Primary Sponsor
|
| Name |
Neha |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| 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 Geetanjali Kaul |
Maharishi Markandeshwar Medical College and Hospital |
Orthopedics department, Physiotherapy OPD, Room no. 510
Solan
HIMACHAL PRADESH |
7018518005
drgeetanjalikaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharishi Markandeshwar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progressive Muscle Relaxation |
A total of 30 patients will be recruited in this study on the basis of inclusion criteria. The written consent form will be taken from each patient who voluntarily to participate. At baseline, all participants, demographic data, Dyspnea 12 scale, and Fatigue severity scale will be recorded. All participant perform progressive muscle relaxation technique under supervision through verbal instruction as follows.
The patient will be instructed to sit comfortably in a relaxed position and close the eyes. The therapist will demonstrate the whole Progressive muscle relaxation technique to the patient and then the patient will repeat the procedure.
The therapist will instruct the patient to place one hand on the abdomen and then take a deep breath through the nose and exhale. The patient will repeat 3-5 cycles of deep breathing.
duration - 1 week
frequency - 2 times a day for 15 minutes per session
|
| Comparator Agent |
Progressive Muscle Relaxation |
A total of 30 patients will be recruited in this study on the basis of inclusion criteria. The written consent form will be taken from each patient who voluntarily to participate. At baseline, all participants, demographic data, Dyspnea 12 scale, and Fatigue severity scale will be recorded. All participant perform progressive muscle relaxation technique under supervision through verbal instruction as follows.
The patient will be instructed to sit comfortably in a relaxed position and close the eyes. The therapist will demonstrate the whole Progressive muscle relaxation technique to the patient and then the patient will repeat the procedure.
The therapist will instruct the patient to place one hand on the abdomen and then take a deep breath through the nose and exhale. The patient will repeat 3-5 cycles of deep breathing.
duration - 1 week
frequency - 2 times a day for 15 minutes per session |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient on anti-tubercular drugs
2. Patient having complain of Dyspnea and Fatigue |
|
| ExclusionCriteria |
| Details |
1. Patients with multi-drug resistant tuberculosis
2. Mentally inadequate patients
3. Patients with neurological conditions
4. Patients with no additional disorder such as Pneumonia, lung carcinoma
5. Un-cooperative patient |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dyspnea-12 scale |
Baseline And 1week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fatigue severity scale |
baseline & 1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Background
Tuberculosis
(TB) is a widespread infectious illness caused by the bacteria Mycobacterium
tuberculosis which is spread by humans through its respiratory pathway and most
usually affects the lungs. According to certain studies, patients who undergo
antitubercular drugs are more likely to suffer from dyspnea, fatigue and other
respiratory complications. Physical therapy plays an important role in
rehabilitation of tuberculosis. Physiotherapy includes a variety of relaxation
exercises and breathing exercise like deep breathing, pursed lip breathing and
progressive muscle relaxation.
Aim
The
aim of this study is to find out the effect of progressive muscle relaxation
technique on dyspnea and fatigue symptoms in patients with extrapulmonary tuberculosis. |