- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296640
BPIT 5-Line Pilot: Interventional Study on Strength, HRV & Injury Risk Reduction (n=23) (BPIT 5-Line)
A Prospective, Single-Center, Interventional Study to Evaluate the 5-Line Principle of Balanced Intensity Training (BPIT) for Enhancing Physical Performance and Reducing Injury Risk
This prospective, single-center, interventional pilot (n=23) evaluates the 5-Line Principle of Balanced Intensity Training (BPIT) over 6 weeks at GFFI Fitness Academy. Participants (18 males aged 22-48, 5 females aged 20-33) will receive BPIT 5-Line Training (3 sessions/week, 6 weeks). No control group. Conducted July 1 - November 30, 2024.
Progressive intensity via anatomical lines: 1. Ground-Based (Low Intensity); 2. Knee-Level (Low-Moderate); 3. Standing (Moderate); 4. Head-Level (Moderate-High); 5. Plyometric/High-Impact (High). Aims to assess changes in strength, HRV, and injury risk.
Study Overview
Detailed Description
STUDY DESIGN: Prospective, single-center, interventional pilot (n=23) with single-group assignment. All participants receive the BPIT 5-Line intervention. Assessments at baseline and Week 6.
INTERVENTION: BPIT 5-Line Training: 3 x 60-minute sessions/week for 6 weeks, progressing across five intensity lines: 1. Ground-Based (Low Intensity, e.g., prone planks); 2. Knee-Level (Low-Moderate, e.g., shoulder press); 3. Standing (Moderate, e.g., half-squat); 4. Head-Level (Moderate-High); 5. Plyometric/High-Impact (High Intensity). Specific exercises detailed in Training Protocol Manual.
OBJECTIVES: Primary - Evaluate BPIT's impact on 1RM strength (e.g., squat, bench press, deadlift) and training-related injury incidence. Secondary - Assess changes in HRV (RMSSD), HRR (bpm in 60s), EMG muscle activation, joint biomechanics (knee valgus, spinal curvature), adherence (% sessions completed), and participant feedback (questionnaires).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110026
- GFFI Fitness Academy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged 22-65 years
- Regular fitness trainees (≥2 sessions/week prior)
- Able to provide informed consent
- No recent musculoskeletal injury (past 3 months)
Exclusion Criteria:
- - Cardiovascular disease or uncontrolled hypertension
- Current musculoskeletal injury or surgery (past 6 months)
- Neurological disorders affecting movement
- Pregnancy
- Use of performance-enhancing substances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- 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
All 23 participants (18 males aged 22-48, 5 females aged 20-33) received BPIT 5-Line Training (3-5 sessions/week, 6 weeks). Intensity progressed via 5 Lines:
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All 23 participants received BPIT 5-Line Training (3-5 sessions/week, 6 weeks).
Intensity progressed via 5 anatomical lines: 1. Ground-Based, Low Intensity; 2. Knee-Level, Low-Moderate; 3. Standing, Moderate; 4. Head-Level, Moderate-High; 5. Plyometric/High-Impact, High Intensity.
Sessions 45-60 min, monitored via HRV, pain, fatigue.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in 1RM Strength
Time Frame: 6 weeks
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Change in one-repetition maximum (1RM) strength for key exercises (e.g., squat, bench press) from baseline to week 6. Measured in kilograms (kg) using standard 1RM testing protocol. Time Frame: Baseline to Week 6 Unit of Measure: kilograms (kg) |
6 weeks
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Injury Incidence
Time Frame: Baseline to Week 6
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Number of new musculoskeletal injuries reported during the study period, defined as any complaint requiring medical attention, training modification, or rest exceeding 1 day. Measured as incidence rate per 100 participant-weeks (normalized for exposure in this 23-participant pilot). Unit of Measure: injuries per 100 participant-weeks |
Baseline to Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Heart Rate Variability (HRV)
Time Frame: Week 6
|
Change in Heart Rate Variability (RMSSD) from baseline to week 6, measured via 60-second daily monitoring using HRV device/app. Time Frame: Baseline to Week 6 Unit of Measure: milliseconds (ms) |
Week 6
|
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Change in Muscle Activation (EMG Amplitude)
Time Frame: Baseline to Week 6
|
Change in Electromyography (EMG) amplitude for key muscle groups during specific exercises from baseline to week 6, measured as percentage of maximum voluntary contraction (%MVC) using EMG equipment. Time Frame: Baseline to Week 6 Unit of Measure: percentage of maximum voluntary contraction (%MVC) |
Baseline to Week 6
|
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Change in Joint Biomechanics (Knee Valgus and Spinal Curvature)
Time Frame: Baseline to Week 6
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Change in knee valgus and spinal curvature angles during functional movements from baseline to week 6, measured in degrees via 3D motion analysis or goniometer. Time Frame: Baseline to Week 6 Unit of Measure: degrees |
Baseline to Week 6
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Training Adherence
Time Frame: Baseline to Week 6
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Percentage of completed training sessions from baseline to week 6, measured via session logs. Time Frame: Baseline to Week 6 Unit of Measure: percentage |
Baseline to Week 6
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Participant Feedback
Time Frame: 6 weeks
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Qualitative feedback from post-study questionnaires, scored on a Likert scale (1-5) for satisfaction and perceived benefit. Time Frame: Week 6 Unit of Measure: units on a scale (1-5) |
6 weeks
|
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Heart Rate Recovery (HRR)
Time Frame: 6 Weeks
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Change in Heart Rate Recovery (bpm decrease in 60 seconds post-exercise) from baseline to week 6, measured via HR monitor. Time Frame: Baseline to Week 6 Unit of Measure: beats per minute (bpm) |
6 Weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BPIT-GFFI-2024-001
- Other → MMSx Authority (Other Grant/Funding Number: MMSx Authority)
Plan for Individual participant data (IPD)
Study Data/Documents
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Individual Participant Data Set
Information identifier: BPIT-GFFI-2024-001Information comments: De-identified individual participant data (strength, HRV, knee valgus, injury logs) available upon reasonable request to Principal Investigator: Dr. Neeraj Mehta, PhD (info@mmsxauthority.com). All supporting documents (Protocol, Ethics, Consent, Observation Logs, AE Forms, Final Report) uploaded under "Study Documents" tab.
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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