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CTRI Number  CTRI/2024/04/066511 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [physiotherapy including yoga]  
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   To study how Yoga affects breathing and heart rate in anxious people 
Scientific Title of Study   Effect of Yoga on Respiratory Rate and Heart Rate Variability in Individuals with Anxiety: An 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  Sakshi Kacholiya 
Designation  PG Student  
Affiliation  Dr. D.Y. PATIL College Of Physiotherapy 
Address  Department of Cardiorespiratory sciences, third floor, Dr. D.Y. PATIL College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9764056000  
Fax    
Email  sakshikacholiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayuri Shah 
Designation  Assistant Professor 
Affiliation  Dr. D.Y. PATIL College Of Physiotherapy Pimpri Pune 
Address  Department of Cardiorespiratory sciences, third floor, Dr. D.Y. PATIL College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  8087861628  
Fax    
Email  mayuri.shah@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mayuri Shah 
Designation  Assistant Professor 
Affiliation  Dr. D.Y. PATIL College Of Physiotherapy Pimpri Pune 
Address  Department of Cardiorespiratory sciences, third floor, Dr. D.Y. PATIL College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  8087861628  
Fax    
Email  mayuri.shah@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr DY Patil College Of Physiotherapy Pimpri Pune Maharashtra-411018  
 
Primary Sponsor  
Name  Dr DY Patil College Of Physiotherapy Pimpri Pune 
Address  Dr DY Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri Pune 411018 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Mayuri Shah  Dr DY Patil College of Physiotherapy  Department of Cardiorespiratory sciences, third floor, Dr DY Patil College of Physiotherapy Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA 
8087861628

mayuri.shah@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr DY Patil College of Physiotherapy Pimpri Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  medications prescribed by psychiatrist  The Control group will receive only medications. Treatment duration will be for 21 days. 
Intervention  yoga  a)Warming up / loosening exercises (05 minutes) This part will contain posture to loosen up body structure its objectives is to increase range of motion and lubricate joints and also to avoid muscle soreness. Greevasanchalana (Neck movements) Skandhachakra (Shoulder chakra) Januchakra (knee movements) Katichakrasana(Hip movements ) b) Asanas (30 minutes) Gomukhasana, shashankasana, vajrasana, swastikasana, sukhasana, Each pose will be held approximately 20-30 second with rest periods lasting 30 second to 1 minute between poses. A mixture of standing and seated poses will be introduced and practiced instructions will be to concentrate on their breathing and trying to relaxed. Repetition will be consistent from week to week and linked pose to pose c) Pranayama (05 minutes) following poses will be given to rest the body and to facilitate a state of relaxation and meditation ,abdominal breathing will be emphasized in each program phase. Nadishodhana and Bharamari will be given to facilitate relaxation.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Recently diagnosed cases of Anxiety by a psychiatrist
2.Screening tool: General Anxiety Disorder scale scoring 5-14
3.Willing participants
 
 
ExclusionCriteria 
Details  1. Individuals who cannot follow command
2. Individuals diagnosed with any other disorder other than anxiety and depression
3. Individuals with any disability who cannot perform any Yogasana, pranayama
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
General Anxiety Disorder Scale   21 days  
 
Secondary Outcome  
Outcome  TimePoints 
respiratory rate
heart rate variability  
21 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/05/2024 
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="0"
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  

NEED OF STUDY

•       The global prevalence of anxiety is 33.8% and the prevalence of anxiety in India is 37%. The rising prevalence of anxiety underscores the importance of research aimed at identifying potential protective factors that may mitigate the negative consequences associated with this mental health challenge. It is imperative to integrate and centralize existing knowledge to provide targeted care for a particular and expanding demographic in society. This group requires specialized interview, assessment, and therapeutic skills.

•       Anxiety is increasing in modern world specifically after pandemic. So it is important to recognize and plan anxiety because it affects society in many ways.On certain occasions, the repercussions of anxiety can escalate to severe outcomes, including a propensity for suicide attempts. Regrettably, India holds one of the highest rates of teenage suicide globally, and the incidence of students attempting suicide due to the fear and pressure associated with exams is on the rise

•       The availability of psychopharmacological treatment has increased but the response and tolerability remain unpredictable and inconsistent. While psychotropics agents can be lifesaving, Treatment resistance is a growing problem and there are millions of patients world-wide whose anxiety is not fully resolved despite multiple trails of psychopharmacologic agents. Investigators are performing many researches on yoga and other mindfulness exercises focusing on nonpharmaceutical and noninvasive treatments for anxiety due to adverse side effects of medication treatment and less effective in some circumstances. Thus, the quest demand for nonpharmacological treatment modalities has been increasing.

•       The need for adaptation and the attainment of an optimal work-life balance becomes essential to navigate the daily stresses arising from mounting pressures and expectations. Various physiotherapy approaches are both cost-effective and safe. Importantly, they lack adverse side effects. These approaches actively engage the patient and impart practical skills and insights for application in daily life. Following a thorough physiotherapy observational and/or evaluative assessment, the approaches prioritize functional (mental) aspects and health promotion. In primary care, numerous proficient colleagues may not be adequately equipped to assist individuals with mental health concerns. This limitation is not due to the nature of the illness but rather stems from a lack of knowledge on how to effectively address mental health issues.

•       Defined by the American Psychological Association, anxiety involves persistent intrusive thoughts leading to perpetual worry and tension. It is further characterized by an excessive amount of worry and fear relative to everyday situations, resulting in adverse thoughts and predictions about future events. The repetitive nature of heightened worry and fear contributes to adverse health outcomes.

            â€¢       The implementation of yoga as an intervention for anxiety holds the potential to enhance both the physical health and psychological well-being of individuals,                  consequently improving their overall quality of life. Despite its widespread popularity and recognized psychological and physiological benefits, there remains a               lack of comprehensive studies assessing the measurable outcomes of yoga in terms of disease severity, along with a notable absence of follow-up research on                   yoga interventions. Given this context, there is a requirement to investigate the efficacy of yoga for caregivers, with the specific aim of mitigating their anxiety                 levels and enhancing their overall quality of life.

          •       Contemporary lifestyles are marked by high levels of stress and anxiety. Researchers are actively conducting numerous studies on yoga and other mindfulness                   practices. The emphasis is on exploring non-pharmaceutical and non-invasive interventions for anxiety, primarily due to the adverse side effects associated with               medication treatments, which are also deemed less effective in certain situations.

           â€¢       The well-established understanding is that a higher heart rate (HR) is linked to lower variability in RR-intervals. Consequently, it becomes crucial to adjust heart               rate variability (HRV) for the concurrent heart rate, especially considering the significant changes in heart rate in response to academic stress during examinations.

           â€¢       Nevertheless, there is a need for further clarification regarding the mechanisms through which yogic breathing techniques (YBT) engage with the autonomic and              cognitive functions of the human nervous system.


 
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