FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 

 

 

 

 
Close