| CTRI Number |
CTRI/2024/11/076599 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exercises Programme for post-COVID-19 people |
|
Scientific Title of Study
|
Comprehensive Exercise Programme Regime for COVID-19 Survivors. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DUBBA NAGA RAJU |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Dr.DUBBA NAGA RAJU.NRI COLLEGE OF PHYSIOTHERAPY,NRI ACADEMY OF SCIENCES,
CHINAKAKANI,MANGALAGIRI,Guntur
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9703212170 |
| Fax |
|
| Email |
nagarajudubba2170@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shenbaga Sundaram Subramanian |
| Designation |
Professor |
| Affiliation |
|
| Address |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105. Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu. Kancheepuram TAMIL NADU 602105 India |
| Phone |
9003913514 |
| Fax |
|
| Email |
subramanian.scpt@saveetha.com |
|
Details of Contact Person Public Query
|
| Name |
DUBBA NAGA RAJU |
| Designation |
|
| Affiliation |
|
| Address |
Dr.DUBBA NAGA RAJU.NRI COLLEGE OF PHYSIOTHERAPY,NRI ACADEMY OF SCIENCES,
CHINAKAKANI,MANGALAGIRI,Guntur
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9703212170 |
| Fax |
|
| Email |
nagarajudubba2170@gmail.com |
|
|
Source of Monetary or Material Support
|
| 4-131, Nimra Institute of Medical Sciences, Nimra Nagar, Jupudi, Ibrahimpatnam, Krishna Dist, Andhra Pradesh, Pin:521456 |
|
|
Primary Sponsor
|
| Name |
DUBBA NAGA RAJU |
| Address |
Dubba Naga Raju,NRI College of Physiotherapy,NRI Academy of Sciences, Chinakakani,Mangalagiri,Andhrapradesh.522503 |
| 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 |
| DUBBA NAGA RAJU |
NIMRA HOSPITAL |
Department of Community Medicine, 4-131,Nimra Nagar, Jupudi(V),Ibrahimpatnam(M), Krishna Dist,Andhra Pradesh Krishna ANDHRA PRADESH |
9703212170 0866-2881852 nagarajudubba2170@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nimra Institute of Medical Sciences (NIMS) TEACHING HOSPITAL & RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID-19 Survivors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Exercise Programme Regime for COVID-19
Survivors. |
Phase 1: Initial Recovery-gentle movements (Weeks 1-4).
Phase 2:Progressive Strengthening (Weeks 5-8).
Phase 3: Advanced Conditioning (Weeks 9-12) |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects who recovered from COVID-19
2 Women below 45years of age
3 Men below 55 years of age
|
|
| ExclusionCriteria |
| Details |
1 Subjects not recovered from covid-19
2 Subjects not affected by covid-19
3 High-risk population
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6-minute walk test,
sit and reach test and
|
12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life questionnaire |
12weeks |
|
|
Target Sample Size
|
Total Sample Size="119" Sample Size from India="119"
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)
|
21/11/2024 |
| 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="4" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Comprehensive Exercise Programme Regime for COVID-19 Survivors. Background of the Study: A Highly communicable disease called COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the novelty of this disease, many of its dimensions are unknown. This study examines the post-COVID-19 restoration challenges, with exclusive attention directed at some deferring events like fatigue, muscle weakness, and sleep disturbances. These problems, when left unattended, have a potential to further affect daily activities leading to more severe issues such as muscle atrophy and restricted mobility. This study is aimed at assessing the outcomes of the structured exercise program that enhances physical fitness, muscle strength, flexibility and quality of life among one of the special populations who are COVID 19 survivors. Purpose of Trial: The study intends to determine the effectiveness of breathing, flexibility, strength, and cardiovascular exercises which have been integrated into a structured exercise program on the recovery and functional independence of these individuals. The study population involves 119 out of 200 survivors from the target population; the design is experimental conducting a survey, data collection, interaction and finally data analysis The exercise began with three phases which aimed at enhancing different parts of the body over a period of 12 weeks commencing with the mildest exercises and increasing as strength and mobility increased. The supposition is that it’s possible to benefit from this program and lead to some measurable changes and improve the health of the survivors’ burdened by COVID-19 disease. |