| 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
|
|
|
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
|
|
|
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.
• 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.
• 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.
• 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.
|