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|---|---|---|---|
| Other → MMSx Authority | Other Grant/Funding Number | MMSx Authority |
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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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPIT 5-Line Training | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPIT 5-Line Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 1RM Strength | 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 |
| Injury Incidence | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability (HRV) | 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 |
| Change in Muscle Activation (EMG Amplitude) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GFFI Fitness Academy | New Delhi | National Capital Territory of Delhi | 110026 | India |
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| Label | URL |
|---|---|
| Complete Study Documentation Package - BPIT 5-Line Pilot (Protocol, Ethics, Consent, Logs, AE, Report, Closeout) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| BPIT-GFFI-2024-001 | Individual Participant Data Set | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2024 | Nov 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2024 | Nov 18, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2024 | Nov 18, 2025 | ICF_002.pdf |
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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 |
| Change in Joint Biomechanics (Knee Valgus and Spinal Curvature) | 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 |
| Training Adherence | 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 |
| Participant Feedback | 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 |
| Heart Rate Recovery (HRR) | 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 |
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. |