- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07256717
BPIT 5-Week Multi-Site Study: Movement Efficiency, Mobility & Neuromuscular Adaptation (BPIT_5LINE_369)
Balanced Progressive Intensity Training (BPIT): A Five-Week Multi-Site Clinical Evaluation of Functional Movement, Mobility, and Neuromuscular Adaptation in Healthy Adults (18-65 Years)
This prospective, multi-site, single-arm interventional study evaluates the 5-Line Principle of Balanced Progressive Intensity Training (BPIT) over 5 weeks in healthy adults aged 18-65 years. All participants receive supervised BPIT sessions (3-5 per week) progressing through five intensity lines defined by anatomical landmarks and ground reaction force:
Ground-Based (Low) Knee-Level (Low-Moderate) Standing (Moderate) Head-Level (Moderate-High) Plyometric (High-Impact)
The study aims to quantify improvements in functional movement efficiency, joint mobility, postural control, strength adaptation, and heart-rate variability while monitoring safety and individual overload indicators.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Outcome Measures
Change in Functional Movement Screen (FMS) total score from baseline to Week 5 Change in Y-Balance Test reach distance (composite score) Timeframe: Baseline and Week 5
Secondary Outcome Measures
Change in 1-RM or estimated strength (squat, deadlift, overhead press) Change in resting HRV (RMSSD) Change in joint range of motion (goniometry) and postural sway Incidence of training-related discomfort or minor injury Timeframe: Baseline, weekly, and Week 5
Arms/Intervention Experimental: BPIT 5-Line Training Group Intervention: Behavioral: Balanced Progressive Intensity Training (BPIT) 5-Line Method Description: 5-week supervised progressive training using the BPIT 5-Line framework (ground-based → plyometric) Eligibility
Ages Eligible: 18 Years to 65 Years Sexes Eligible: All Accepts Healthy Volunteers: Yes
Inclusion Criteria
Healthy adults with regular exercise history Able to attend 3-5 training sessions/week Signed informed consent
Exclusion Criteria
Recent injury (<3 months) Known cardiovascular, metabolic, or orthopaedic contraindications Pregnancy
Study Locations 13 Locations in India 2 Locations in USA, (Details of the location is uploaded on mmsxauthority.com webiste)
MMSx Authority , USA, GFFI Fitness Academy, New Delhi BodyGNTX USA BFS/AIHFT-approved facilities
Countries of Recruitment India U.S. FDA-regulated? No / No / No Human Subjects Protection Review Board Status Approved (or Submit for review if not yet) Board Name: Institutional Ethics Committee - MMSx Authority / GFFI Approval Number: BPIT-MULTI-2025-001 (or pending) Data Monitoring Committee No
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madhya Pradesh
-
Burhānpur, Madhya Pradesh, India, 450331
- Recruiting
- Indian Institute of Kinesiology & Biomechanics Science (IIKBS)
-
Contact:
- Dr. Anya Petrova, M.D., Ph.D. (Sports Med)
- Phone Number: +919990744422
- Email: info@iikbs.org
-
Contact:
- Laura Green, R.N.
- Phone Number: +91-9990744422
- Email: info@iikbs.org
-
Sub-Investigator:
- Pankaj Mehta, MSc
-
-
National Capital Territory of Delhi
-
Delhi, National Capital Territory of Delhi, India, 110032
- Recruiting
- Shri Mahaveer Ortho Clinic
-
Contact:
- Dr Karun Jain, MBBS, D'Ortho, MS Ortho
- Phone Number: +91-8285257076
- Email: karunjain@live.com
-
Contact:
- Karun Jain, MBBS
-
Sub-Investigator:
- Sumit Chaudhary, MMSx Pro, CPT,
-
New Delhi, National Capital Territory of Delhi, India, 110026
- Recruiting
- GFFI Fitness Academy
-
Contact:
- Sumit Khoney, MMSx Pro / CPT
- Phone Number: 08586836625
- Email: info@gffi-fitness.org
-
Contact:
- Pankaj Mehta, M.P.Ed.
- Phone Number: +918447431421
- Email: Pankaj@gffi-fitness.org
-
Principal Investigator:
- Pankaj Mehta, M.P.Ed.
-
New Delhi, National Capital Territory of Delhi, India, 110063
- Recruiting
- Active India Health & Fitness Trust (AIHFT)
-
Sub-Investigator:
- Pankaj Mehta, MSc
-
Contact:
- Anupama Mahajan, Ph.D. (Maths)
- Phone Number: +91-9873194695
- Email: pankajprocoach@gmail.com
-
Contact:
- Anupama Mahajan, PhD
- Phone Number: +919873194695
- Email: pankajprocoach@gmail.com
-
New Delhi, National Capital Territory of Delhi, India, 110092
- Recruiting
- Body Mechanics Gym P Ltd
-
Contact:
- Sunny Ghambir, CPT
- Phone Number: 9990960606
- Email: neeraj.gffi@gmail.com
-
Contact:
- Gaurav Sharma, CPT, CSCS
- Phone Number: 9990960606
- Email: neeraj.gffi@gmail.com
-
Sub-Investigator:
- Pankaj Mehta, M.P.Ed.
-
-
Uttar Pardesh
-
Greater Noida, Uttar Pardesh, India, 201310
- Recruiting
- Regain Fitness Zone
-
Sub-Investigator:
- Sumit Chaudhary, MMSx Pro, CPT,
-
Sub-Investigator:
- Pankaj Mehta, M.P.Ed.
-
Contact:
- Chetan Sethi, MMSx Pro / CPT
- Phone Number: +91-98998200922
- Email: contact@regainfitnesszone.com
-
Contact:
- Chetan Sethi, CPT, CSCS
- Phone Number: +919899820922
- Email: contact@regainfitnesszone.com
-
-
Uttar Pradesh
-
Agra, Uttar Pradesh, India, 282005
- Recruiting
- GFFI Fitness Academy
-
Contact:
- Jeet Sharma, CPT
- Phone Number: +91-9990744422
- Email: nutrieon.reports@gmail.com
-
Contact:
- Gerik Mehta, CPT, CSCS
- Phone Number: 8586836625
- Email: gerik.mehta9@gmail.com
-
-
-
-
Ohio
-
Columbus, Ohio, United States, 43220
- Recruiting
- BodyGNTX Fitness Institute
-
Contact:
- Neeraj Mehta, Ph.D. (Biomechanics)
- Phone Number: 6148228038
- Email: neeraj.gffi@gmail.com
-
Contact:
- Ashita Malhotra, GCP
- Phone Number: 6148228038
- Email: neeraj.gffi@gmail.com
-
Principal Investigator:
- Neeraj Mehta, PhD
-
Powell, Ohio, United States, 43065
- Recruiting
- MMSx Authority Biomechanics Department
-
Contact:
- Tina Malhotra, MMSx Pro / CPT
- Phone Number: 6144775031
- Email: mmsxauthority@gmail.com
-
Contact:
- Sunita Malhotra, GCP
- Phone Number: 6144776065
-
Powell, Ohio, United States, 43065
- Recruiting
- MMSx AUTHORITY INSTITUTE FOR MOVEMENT MECHANICS & BIOMECHANICS RESEARCH (COORDINATING CENTER)
-
Contact:
- Neeraj Mehta, Ph.D. (Biomechanics)
- Phone Number: 6148228038
- Email: neeraj.gffi@gmail.com
-
Principal Investigator:
- Neeraj Mehta, PhD
-
Contact:
- Sunita Malhotra, GCP
- Phone Number: 6144776065
- Email: sunita_5757@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-65 years Generally healthy with regular physical activity history (at least 1-2 sessions per week for the past 3 months) Able to commit to 3-5 supervised training sessions per week for 5 weeks Willing and able to provide written informed consent Cleared by pre-screening (no acute injury, no contraindications)
Exclusion Criteria:
- Acute musculoskeletal injury within the past 3 months Known cardiovascular, metabolic, or orthopaedic conditions that contraindicate exercise Pregnancy or planning pregnancy Use of medications or supplements that significantly affect muscle recovery or performance (e.g., corticosteroids, anabolic agents) Inability to follow the BPIT protocol or attend required sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BPIT 5-Line Training Group
All participants receive the 5-week Balanced Progressive Intensity Training (BPIT) program using the 5-Line Principle (ground-based → knee-level → standing → head-level → plyometric) under supervised sessions 3-5 times per week.
|
5-week supervised progressive training using the BPIT 5-Line framework developed by Dr. Neeraj Mehta.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Efficiency Score (MES, 0-10)
Time Frame: Baseline (Week 0) and end of study (Week 5)
|
Change from baseline in the proprietary Movement Efficiency Score (MES), a validated composite metric of biomechanical function, movement quality, and postural alignment (derived from MMSx Flaw Checklist, visual/video analysis, and functional mapping).
|
Baseline (Week 0) and end of study (Week 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion (ROM)
Time Frame: Baseline and Week 5
|
Change from baseline in joint range of motion (degrees) measured by goniometry at key sites (shoulder, hip, spine, ankle).
|
Baseline and Week 5
|
|
VAS Pain Score
Time Frame: Baseline and Week 5
|
Change from baseline in participant-reported pain/discomfort on a 0-10 Visual Analog Scale.
|
Baseline and Week 5
|
|
Strength Index
Time Frame: Baseline and Week 5
|
Change from baseline in Strength Index calculated as Reps × Load (or estimated 1RM where applicable) for key movements.
|
Baseline and Week 5
|
|
Mobility Limitation (%)
Time Frame: Baseline and Week 5
|
Change from baseline in self-reported percentage limitation in daily functional tasks due to mobility restrictions.
|
Baseline and Week 5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability (HRV - RMSSD)
Time Frame: Baseline and Week 5
|
Change from baseline in resting heart rate variability (RMSSD) as a biomarker of autonomic recovery.
|
Baseline and Week 5
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BPIT-MULTI-2025-001
- MACREB-BPIT-2025-014 (Other Identifier: nstitutional Ethics Committee Approval Number (MMSx Authority / GFFI Ethics Committee))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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