| CTRI Number |
CTRI/2024/11/077396 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The role of movement therapy in fighting obesity and inactive lifestyles |
|
Scientific Title of Study
|
The role of Kinesiotherapy in combating obesity and sedentary lifestyles among adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No 316, Department of Physiotherapy, School of Allied Health
Science, Galgotias University, Plot No.2, Sector 17A, Opposite Buddha International Circuit, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8057366438 |
| Fax |
|
| Email |
Jyoti.yadav@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Savitri Kumari |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E004, Department of Physiotherapy, School of Allied
Health Science, Galgotias University, Plot No.2, Sector 17A
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9942566809 |
| Fax |
|
| Email |
savi37242@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No 316, Department of Physiotherapy, School of Allied Health
Science, Galgotias University, Plot No.2, Sector 17A
Opposite Buddha International Circuit, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH,203201,
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
08057366428 |
| Fax |
|
| Email |
Jyoti.yadav@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Plot No.2, Sector 17A, Opposite Buddha International Circuit Greater Noida, Gautam Buddha,Nagar, Uttar Pradesh India,203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No2, Sector 17A Opposite Buddha International International Circuit, Greater Noida, Buddha Nagar, Uttar Pradesh, India, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti Yadav |
Galgotias University |
Room No E004,Department of Physiotherapy, School of Allied
Health Science, Galgotias University, Plot No.2, Sector 17A,
Opposite Buddha International Circuit, Greater Noida,
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
08057366428
Jyoti.yadav@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, (2) ICD-10 Condition: Z683||Body mass index (BMI) 30-39, adult, (3) ICD-10 Condition: Z723||Lack of physical exercise, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
1. Initial Assessment
2. Exercise Therapy:-Frequency-2 to 3 times per week
Sessions Duration-30 to 45 minutes.
3. Pain Management and Manual Therapy:-Heat or Cold Therapy
-Manual Therapy
-TENS(1 to 2 times per week initially).
4. Postural Education and Ergonomics.
5. Lifestyle Education and Behavior Modification.
Progression Over Time :-
-Increase aerobic exercise duration (up to 30 minutes) and frequency(3-4 times per week).
Session 1: Aerobic exercise (15 minutes) + Strength training (1 set of 8-12 reps) + Stretching (10 minutes)
Session 2: Aerobic exercise (15 minutes) + Balance training + Manual therapy for pain management
Session 3: Aerobic exercise (20 minutes) + Postural education + Flexibility exercises (10 minutes)
Session 4 (optional): Short aerobic activity (15 minutes) + Stretching + Pain management techniques
|
| Intervention |
Kinesiological exercises |
All the patients having a BMI of more than 25 will receive different methods of Kinesiotherapy, which will help them burn calories and improve metabolism. Active and Passive methods of kinesiotherapy include training on a double unstable platform, physical exercises in an ergo cycle training, walking speed functional tests result assessment, Strength training, Flexibility and Stability training, starting from Low-impact cardio to High-Intensity Interval Training. A minimum of 150 mins. moderate activity is required daily. Overall Duration: 12 to 24 weeks (3 to 6 months). This timeframe is generally sufficient for observing measurable changes in weight, fitness, and behavior.
1.Aerobic Exercises:
Frequency: 3 to 5 days per week.
Duration per Session: 30 to 60 minutes, gradually increasing. 2. Resistance Training:
Frequency: 2 to 3 days per week on non-consecutive days to allow for muscle recovery.
Duration per Session: 20 to 40 minutes.
3. Flexibility and Mobility Training:
Frequency: At least 2 days per week.
Duration per Session: 5 to 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range: adults between the ages of 20 to 40 and may involve adolescents
2.Body Mass Index, or BMI:
Generally, those with a BMI of ≥ 25 (overweight) or ≥ 30 (obesity) would be included. Patients with a BMI of 40 or higher, who are categorized as morbidly obese, may also be included.
3. A Sedentary Way of Life: those with minimal levels of physical activity, which is defined as fewer than 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity exercise per week.
those whose regular activities or jobs require them to sit for extended periods of time or move little.
4.Availability to Take Part:
people who are prepared to follow recommended exercise regimens and participate in kinesiotherapy procedures.
5. Mobility :
those who can still engage in low-impact workouts while having mild to moderate joint issues or limited mobility.
6.No recent injuries or surgeries:
people who have any recent injuries that might prevent them from participating in exercise therapy or who have had surgery within the last three months.
|
|
| ExclusionCriteria |
| Details |
1.Normal weight:Unless the primary goal is to decrease the sedentary behaviours, people who do not meet the criteria for being overweight or obese may be disqualified.
2.Pregnant women
3.Neurological conditions
4.Recent surgery or major surgery
Involvement in other weight-loss interventions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinesiotherapy |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce weight and combat physical inactivity |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/12/2024 |
| 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)
|
Not Applicable |
| 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 pilot study investigates the role of Kinesiotherapy in combating obesity and sedentary lifestyles among Indian adults. As India is undergoing a rapid epidemiological transition from underweight to overweight/obese population. The study thus aims to counter the challenges of obesity. Also, integrates approaches that combines physical therapy with lifestyle changes, paving the way for healthier and more active communities. To observe the efficacy of Kinesiotherapy in addressing specific obesity and sedentarism needs. It focuses on improving movement efficiency, strength, and endurance, making physical activity more accessible and enjoyable for individuals. By addressing personal goals and health conditions, kinesiotherapy helps foster sustainable habits, enhance motivation, and improve overall well-being. Additionally, it can educate individuals about the importance of regular exercise, ultimately leading to weight management and better health outcomes. |