| CTRI Number |
CTRI/2025/07/090690 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of exercise interventions in improving respiratory function and sleep quality in obese individuals with Obstructive Sleep Apnea |
|
Scientific Title of Study
|
A study to compare the effects of upper body plyometrics,circuit interval training and conventional exercise on respiratory function and sleep quality in obese individuals with obstructive sleep apnea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RJayabharathi |
| Designation |
Assistant professor |
| Affiliation |
Faculty of Physiotherapy,Dr.M.G.R.Educational and Research Institute |
| Address |
Faculty of Physiotherapy,Dr.M.G.R.Educational and Research Institute,Velappanchavadi,Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8122027781 |
| Fax |
|
| Email |
jayabarathi.physio@drmgrdu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr.M.G.R Educational and Research Institute |
| Address |
Faculty of Physiotherapy,
Dr.M.G.R Educational and Research Institute,
Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ramachandran |
| Designation |
Professor |
| Affiliation |
Faculty of Physiotherapy, Dr.M.G.R Educational and Research Institute |
| Address |
Faculty of Physiotherapy,
Dr.M.G.R Educational and Research Institute
Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
9841075381 |
| Fax |
|
| Email |
ramachandran.physio@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy,
Dr.M.G.R Educational and Research Institute,Velappanchavadi,Chennai-600077 |
|
|
Primary Sponsor
|
| Name |
RJayabharathi |
| Address |
Faculty of Physiotherapy,
Dr.M.G.R Educational and Research Institute,Velappanchavadi,Chennai-600077 |
| 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 |
| RJayabharathi |
Faculty of Physiotherapy,ACS Medical College and Hospital |
Out patient department, Faculty of Physiotherapy,ACS Medical College and Hospital,
Velappanchavadi,Chennai-600077.
Chennai
TAMIL NADU |
8122027781
jayabarathi.physio@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACS MEDICAL COLLEGE HOSPITAL, A Constituent unit of Dr.M.G.R Educational and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G473||Sleep apnea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHEST MOBILIZATION EXERCISE WITH BREATHING EXERCISE |
45 minutes/day for 3 alternate days in a week for 12 weeks |
| Intervention |
GROUP A- UPPER BODY PLYOMETRICS
GROUP B - CIRCUIT INTERVAL TRAINING
|
GROUP A- UPPER BODY PLYOMETRICS
45 minutes/day for 3 alternate days /week for 12 weeks
GROUP B - CIRCUIT INTERVAL TRAINING
45 minutes/day for 3 alternate days /week for 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults with BMI greater than 30kg/m .2
Subjects who confirmed to the diagnostic criteria of OSA(AHI between 5-30 events/hr)
Subjects not undergoing any treatment (CPAP/ oral appliance/ nasal surgery)
Both male and females between age group 30-45 years
Individuals with decreased lung function parameters –FEV1, FVC, MVV
Subjects with Pittsburgh Sleep Quality Index score greater than 5 indicating poor sleep quality.
|
|
| ExclusionCriteria |
| Details |
Individuals taking medications like sedatives, opioids.
Other respiratory conditions that may lead to hypoventilation like Neuromuscular disorders, chest wall abnormalities, COPD.
Significant cardiovascular or musculoskeletal limitations
Other comorbid conditions like Hypothyroidism.
Females with h/o PCOD, Pregnancy.
Individuals with significant psychiatric disorders like severe depression, psychosis.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respiratory function and Sleep Quality |
6 weeks,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upper body composition |
6 weeks,12weeks |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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 1 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="6"
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
|
This PhD study investigates the impact of upper body plyometric exercises and circuit interval training on respiratory function, sleep quality, and body composition in obese individuals with mild to moderate Obstructive Sleep Apnea (OSA). With obesity-related OSA on the rise, the research aims to explore how targeted upper-body exercise interventions can improve pulmonary parameters such as FEV1/FVC ratio and maximum voluntary ventilation (MVV), as well as sleep outcomes including apnea-hypopnea index (AHI), oxygen saturation, heart rate, and snoring episodes, measured using a home sleep apnea device. Subjective sleep quality will be assessed using a sleep apnea questionnaire, and body composition through a body fat analyzer. The randomized controlled trial includes 123 participants with BMI over 30, divided into three groups: one undergoing upper body plyometric training, another circuit interval training, and a control group. The objective is to evaluate changes in ventilation efficiency, sleep quality and to understand the influence of structured exercise on sleep patterns and respiratory health, considering the complex interplay between obesity, pulmonary function, and sleep disturbances.Results will be revealed at the end of the study. |