| CTRI Number |
CTRI/2025/07/091754 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| 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
|
A study to see how much Mat Pilates Affects Blood Pressure and Heart Rate Recovery in College going Students with early sign of high Blood Pressure |
|
Scientific Title of Study
|
Effect of mat Pilates on blood pressure (BP), heart rate recovery (HRR) in prehypertensive college going students |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushka |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Mahadeshwar Institute of physiothrtapy and Rehabilitation |
| Address |
Room no.5,Electrotherapy OPD Maharishi Mahadeshwar Institute of Physiotherapy And Rehabilitation, Mullana- Ambala, Haryana, India
Ambala, Haryana,code-133207 India
Ambala
HARYANA
133207
India |
| Phone |
9041653104 |
| Fax |
|
| Email |
anu1540574@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mousami Saha |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Mahadeshwar Institute of physiotherapy and Rehabilitation, |
| Address |
Room no.5,Electrotherapy OPD Maharishi Mahadeshwar Institute of Physiotherapy And Rehabilitation, Mullana- Ambala, Haryana, India
Ambala, Haryana,code-133207 India
Ambala
HARYANA
133207
India |
| Phone |
9366787310 |
| Fax |
|
| Email |
msaha0029@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mousami Saha |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Mahadeshwar Institute of physiotherapy and Rehabilitation, |
| Address |
Room no.5,Electrotherapy OPD Maharishi Mahadeshwar Institute of Physiotherapy And Rehabilitation, Mullana- Ambala, Haryana, India
Ambala, Haryana,code-133207 India
Ambala
HARYANA
133207
India |
| Phone |
9366787310 |
| Fax |
|
| Email |
msaha0029@gmail.com |
|
|
Source of Monetary or Material Support
|
| Electrotherapy OPD, Ground Floor, Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana-Ambala, Haryana, India (133207) |
|
|
Primary Sponsor
|
| Name |
Anushka |
| Address |
Maharishi Mahadeshwar Institute Of Physiotherapy and Rehabilitation, Mullana- Ambala, Haryana,India -133207 |
| 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 |
| Anushka |
Dr Anushka |
Electrotherapy OPD, ground floor, Maharishi Mankandeshwar Institute of Physiotherapy and Rehabilitation, Mullana- Ambala, Haryana, India
Ambala
HARYANA |
9041653104
anu1540574@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee,Maharishi Markandeshwar Institute of medical sciences and research,mullna,ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prehypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- Mat Pilates |
The Mat Pilates program is structured over a period of four weeks, with sessions held five days a week, each lasting 30 minutes. The daily workout includes a series of 10 foundational Mat Pilates exercises: hundred preps, single leg stretch, double leg stretch, single leg circle, side leg bicycle, side leg kick, swan, knee push-ups, half roll-up, and shoulder bridges. The program begins in the first week with 7 repetitions of each exercise performed for 3 sets. As the weeks progress, the number of repetitions gradually increases to build strength, flexibility, and endurance. By the final week of the program, participants will be completing 20 repetitions of each exercise, still maintaining 3 sets. This gradual progression ensures safe and effective development of core stability, muscular control, and overall body conditioning. |
| Comparator Agent |
Group 2- Control Group
|
The control group follows a structured exercise protocol over a period of four weeks, with sessions conducted five days a week, each lasting 20 minutes. The routine begins with 10 minutes of focused breathing exercises to promote relaxation and improve respiratory function. This is followed by basic flexibility exercises such as neck stretches, cat-cow stretch, and hamstring stretch to enhance joint mobility and muscle flexibility. Additionally, the program includes simple free-hand exercises targeting both the upper and lower limbs to encourage light physical activity. Alongside the physical routine, participants receive education on healthy dietary habits and proper sleep hygiene, promoting a holistic approach to overall well-being.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
College students aged 18 to 25 years
Prehypertensive (blood pressure between 120/80 mmHg and 139/89 mmHg)
Not involved in regular exercise
Willing to take part in the full 4-week protocol |
|
| ExclusionCriteria |
| Details |
Students Diagnosed with hypertension.
Having other major health problems (like diabetes or heart disease)
Taking medicines that affect heart rate or blood pressure
Smokers or recently quit smoking
Have any injuries or conditions that prevent exercise
Already doing Pilates or regular exercise recently or miss more than 25% of sessions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Heart Rate Recovery |
4 week protocol
pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 randomized controlled trial evaluates the effects of a 4 week mat Pilates intervention on resting blood pressure and heart rate recovery following exercise in prehypertensive college going students. Participants are split into an Intervention group and the control Group.The Intervention group engaging in structured Mat Pilates sessions and conventional exercise protocol, and a control group recieves the conventional exercise protocol only. Measurements of systolic and diastolic blood pressure are taken, along with heart rate at rest and heart rate maximum are taken, after that heart rate recovery are calculated after 1 min and after 2 mins. Both before and after the intervention. Ultimately, this design allows you to isolate the impact of Pilates on cardiovascular regulation, with findings that may support mat Pilates as a non pharmacological strategy for early hypertension management in young adults. |