NCT07128862

Brief Summary

A 8 weeks, single-blinded randomized controlled trial will be conducted at Pakistan Sports Board (PSB). Forty-four athletes (18-35 years) will be randomized into Group A (HL-RT + BFR, n = 22) and Group B (HL-RT only, n = 22). BFR will be applied at 50% limb occlusion pressure during lower-body exercises (squats, leg press). Both groups trained 3x/week for 4 weeks at 70-80% 1RM. Outcomes included 1RM strength, squat endurance, push-up performance, and International Physical Activity Questionnaire (IPAQ) scores.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

July 21, 2025

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 1RM strength

    The 1 Repetition Maximum (1 RM) Testing protocol determines quadriceps maximal strength through identifying the maximum weight an individual can lift in a single attempt with exercises that include the leg press or squat and leg extension movements.

    6 weeks

  • Squat Endurance

    Experts have established the validity of 3-5 RM squats as a strength test because they correlate strongly with quadriceps force output and exhibit excellent reliability (ICC \> 0.90) through standardization of stance and depth and rest periods. Maximal bodyweight squats at 60-70% 1 RM or to complete failure serve as reliable (ICC \~0.70-0.85) and moderate tests of endurance even though hip and core involvement affects validity.

    6 weeks

  • Push Up Performance

    The push-up test is largely used to evaluate upper body endurance and strength (chest, shoulders, triceps) without much activation of the quadriceps and should not be considered as an indicator of quad endurance or strength. On standard push ups though, quads serve only as stabilizers which means it does not provide much of contribution than exercise such as squatting or doing leg extensions. Push-ups can still be considered a reliable test (ICC \~0.80-0.90) for upper body muscular endurance but cannot be used to assess quadriceps function

    6 weeks

  • International Physical Activity Questionnaire (IPAQ) scores

    International Physical Activity Questionnaire (IPAQ). Interpretation: Higher score indicates increased physical activity in athletes. Effect of interpretation: BFR with heavy load training significantly increases physical activity levels as compared to control. Description: The International Physical Activity Questionnaire - short form (IPAQ-SF) will be used to assess a participant's total physical activity levels. This self-report tool estimates MET-minutes per week across various domains. The score ranges from 0 to an upper limit, with higher scores indicating greater levels of physical activity.

    6 weeks

Study Arms (2)

Heavy-Load Resistance Training with Blood Flow Restriction

EXPERIMENTAL

In this group, the participants will perform three important exercises namely back squats, leg press, and bench press. Those exercises were performed at a training intensity ranging from 70-80% of each person's 1-repetition maximum (1RM). 12 cm pneumatic cuffs was placed proximally on the thigh (for exercise of lower body) and arm (for exercise of upper body), and blood flow restriction was applied through them. Doppler ultrasound was used weekly to measure limb occlusion pressure (LOP) to then set the cuff pressure at 50% of each participant's predetermined LOP. During working sets it was made the cuffs inflated but during rest periods they were deflated. The exercise protocol consists of:

Other: Heavy-Load Resistance Training with Blood Flow Restriction

Heavy-Load Resistance Training Only (HLRT)

EXPERIMENTAL

This control group will perform the identical exercise protocol (same exercises, intensities, volumes, and rest periods) as the BFR group, but without any blood flow restriction application. The same progression criteria will be used for both groups to ensure comparable training stimulus.

Other: Heavy-Load Resistance Training Only

Interventions

Blood Flow Restriction (BFR) Training (also known as "Kaatsu" training is an innovative and increasingly popular exercise technique to improve muscle strength and hypertrophy with relatively low loads. Heavy Load Resistance Training (HL-RT) is one of the most effective exercise methodology that is widely used to increase muscular strength and hypertrophy.

Heavy-Load Resistance Training with Blood Flow Restriction

Heavy Load Resistance Training (HL-RT) is one of the most effective exercise methodology that is widely used to increase muscular strength and hypertrophy.

Heavy-Load Resistance Training Only (HLRT)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants with age between 18 and 35 years.
  • Active individual participating in sport activities at least 3 times a week for the past 6 months.
  • Participants with any non-heart conditions.
  • Individuals voluntarily participating and providing informed consent.
  • Sprinters, Footballer

You may not qualify if:

  • Individuals with DVT or other pulmonary artery disease.
  • Pregnant women or those planning to become pregnant.
  • Participants with recent musculoskeletal injuries (within the 6 months).
  • Individuals currently involved in another study.
  • Participants allergic to or sensitive to the materials used in the BFR bands.
  • Individuals who anticipate being unable to attend all training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Muhammad Hassan, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assesor Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 19, 2025

Study Start

July 30, 2024

Primary Completion

August 30, 2025

Study Completion

September 2, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations