| CTRI Number |
CTRI/2024/12/078331 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy Of Aerobic and Breathing Exercise Programs on Neurocognitive, Pulmonary and Autonomic Functions in Smokers |
|
Scientific Title of Study
|
INVESTIGATING THE EFFICACY OF AEROBIC AND BREATHING EXERCISE ON NEUROCOGNITIVE, PULMONARY AND AUTONOMIC FUNCTIONS IN SMOKERS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Saini |
| Designation |
Assistant Professor |
| Affiliation |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES |
| Address |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES
43 arvalli hills surajkund road
Faridabad
HARYANA
121003
India |
| Phone |
9711365736 |
| Fax |
|
| Email |
preetsphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drnitesh Malhotra |
| Designation |
Professor |
| Affiliation |
Manav Rachna International institute of research and studies |
| Address |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES
Faridabad
HARYANA
121003
India |
| Phone |
9711365736 |
| Fax |
|
| Email |
nitesh.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Preetisaini |
| Designation |
AssistantProfessor |
| Affiliation |
Manav Rachna International institute of research and studies |
| Address |
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIES
Faridabad
HARYANA
121008
India |
| Phone |
9711365736 |
| Fax |
|
| Email |
preetsphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH AND STUDIESPlot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004 |
|
|
Primary Sponsor
|
| Name |
PreetiSainiIndividual |
| Address |
Manav Rachna international institute of research and studies |
| 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 |
| DrPreeti Saini |
Manav Rachna international institute of research and studies |
43B arvalli hill surajkund road,School of allied Health Sciences,Department of Physiotherapy,Physiotherapy OPD ,QF-08
Faridabad
HARYANA |
9711365736
preetsphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MRIIRSReseachEthicalCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SMOKERS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic Exercises intervention |
2-3 month |
| Comparator Agent |
Breathing Exercises |
2-3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria:
1. The sample consists of individuals aged 30-50 years, including current smokers with a smoking history of at least 2 years and non-smokers.
2. Individual willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Individual with respiratory disease other than COPD
2. Individuals suffering from any neurological or vestibular disorders
3. Individuals with presence of any peripheral vascular disease.
4. Individuals with psychosomatic disorder.
5. Persons performing Gym or involved in high impact activity.
6. Any musculoskeletal problem interfering with study
7. Uncontrolled Hypertension
8. Uncontrolled Diabetes Mellitus
9. Diagnosed Cancer Cases
10. Non- cooperative individuals
11. Any other comorbidities interfering with Participation in the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Pulmomary function
2.Cognition
3.Heart rate variability
|
At 0 week and 4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time domain hrv
Frequency domain hrv
FEV1,fVC |
8 week |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
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)
|
30/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
INVESTIGATING THE EFFICACY OF AEROBIC AND BREATHING
EXERCISE PROGRAMS ON NEUROCOGNITIVE, PULMONARY AND AUTONOMIC FUNCTIONS IN
SMOKERS
INTRODUCTION Smoking
has a direct and foremost impact on quality of life (QOL) and life expectancy. (Goldenberget al., 2014). Further frequent
environmental exposure and smoke inhalation might be injurious to health.It is evident that aerobic Exercises and
breathing exercises are an effective and established choice of modality to
improve Pulmonary function, Autonomic function and Cognitive function in
smokers (Erickson et al., 2009). However, there is Paucity of Studies which
have compared and studied the effectiveness of these two-exercise program on
improvement in neurocognitive, autonomic and pulmonary Status of the Smokers Problem statement
There is a lack of studies on the impact
of smoking on neurocognitive, pulmonary, and autonomic functions in India.
Additionally, no effective programs counteract these deficits among smokers.
This study aims to investigate these impacts and determine the effectiveness of
two exercise programs
.
Aim of the study:
Phase 1
Aim This study aims to assess the
impact of smoking and compare the effectiveness of aerobic exercises versus
breathing exercise programs on neurocognitive, pulmonary, and autonomic
function.
Objectives of the Study
•
To study the impact of smoking on
neurocognitive function among smokers.
•
To study the impact of smoking on
pulmonary function in smokers
•
To investigate the impact on autonomic
function amongst smokers
•
To compare the neurocognitive,
autonomic & pulmonary function among smokers and nonsmokers
Phase II
Objectives of the Study
•
To investigate the efficacy of aerobic exercise on neurocognitive, pulmonary& autonomic function in smokers
•
To evaluate the effect of Breathing exercises neurocognitive,
pulmonary& autonomic function in smokers
•
To compare the effect of Aerobic versus Breathing exercises neurocognitive, pulmonary& autonomic function in smokers Procedure
Participants will be
selected from Tobacco cessation center and OPD at Manav Rachna International
institute of Research and studies and from community outreach program by
organizing camps. The purpose and procedure of study will be explained to the
participants and they will be requested to sign an informed consent.
Participants will then be screened as per selection criteria.
At first the demographic data of the participant such as age,
height, weight and BMI will be collected. Following this the assessment of
neurocognition will be done by MOCA, pulmonary function will be assessed by
spirometer and autonomic functions a will be investigated by heart rate
variability device In the second phase of the study, individuals with
changes in pulmonary autonomic and neurocognitive functions selected and will
constitute sample of the study. Written consent will be obtained from all the
participants before the commencement of the second phase, followed by which
baseline evaluation will be done one day prior to the intervention (day zero),
on all the outcome measures i.e., Neurocognition and pulmonary and autonomic
function.
The participants will be randomly allocated into
two group’s i.e Moderate Aerobic Intensity exercise program and Breathing group.
Warm up
program will be administered to both the groups.
|