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Идёт набор NCT07256717

BPIT 5-Week Multi-Site Study: Movement Efficiency, Mobility & Neuromuscular Adaptation

Без фазы С лечением Physical Fitness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Balanced Progressive Intensity Training (BPIT) 5-Line Method.
Кому может быть актуально
Состояния в реестре: Physical Fitness. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Индия
Следующий шаг
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Официальное название

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)

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое Balanced Progressive Intensity Training (BPIT) 5-Line Method
    5-week supervised progressive training using the BPIT 5-Line framework developed by Dr. Neeraj Mehta.

Первичные конечные точки

  • Movement Efficiency Score (MES, 0-10) [Срок оценки: Baseline (Week 0) and end of study (Week 5)]
Вторичные конечные точки (4)
  • Range of Motion (ROM) [Срок оценки: Baseline and Week 5]
  • VAS Pain Score [Срок оценки: Baseline and Week 5]
  • Strength Index [Срок оценки: Baseline and Week 5]
  • Mobility Limitation (%) [Срок оценки: Baseline and Week 5]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Индия · 7 центров
  • Indian Institute of Kinesiology & Biomechanics Science (IIKBS) — Burhānpur
  • Shri Mahaveer Ortho Clinic — Delhi
  • GFFI Fitness Academy — New Delhi
  • Active India Health & Fitness Trust (AIHFT) — New Delhi
  • Body Mechanics Gym P Ltd — New Delhi
  • Regain Fitness Zone — Greater Noida
  • GFFI Fitness Academy — Agra
США · 3 центра
  • BodyGNTX Fitness Institute — Columbus
  • MMSx Authority Biomechanics Department — Powell
  • MMSx AUTHORITY INSTITUTE FOR MOVEMENT MECHANICS & BIOMECHANICS RESEARCH (COORDINATING CENT — Powell

Идентификаторы

NCT: NCT07256717 · BPIT-MULTI-2025-001 · MACREB-BPIT-2025-014

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗