Sports Physical TherapyNCT07128862
Heavy-load Resistance Training With and Without Blood Flow Restriction Therapy in Athletes
A study testing Heavy-Load Resistance Training with Blood Flow Restriction and Heavy-Load Resistance Training Only in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Heavy-Load Resistance Training with Blood Flow Restriction and Heavy-Load Resistance Training Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2024to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Sports Board
Lahore, Punjab Province, 54000
Hafiz Amir, 04299230383
Mubashra Waheed, DPT
About this study
Official title: Effects of Heavy-load Resistance Training With and Without Blood Flow Restriction Therapy on Quadriceps Muscle Strength and Endurance in Athletes
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.
Read the detailed description
This study is a single-blinded randomized controlled trial (RCT) comparing heavy-load resistance training (HLRT) with blood flow restriction (BFR) versus HLRT alone. Participants will be blinded to group allocation, but outcome assessors will not remain blinded throughout the study.
Group A 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:
- Back squats: 4 sets of 6 repetitions
- Leg press: 3 sets of 8 repetitions
- Bench press: 3 sets of 10 repetitions All sets will be followed by a standardized 2-minute rest period. Training load will progressively increased by 2.5-5% when participants can complete all prescribed repetitions with proper form for two consecutive sessions.
Group B: Heavy-Load Resistance Training Only (HLRT) 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.
Post-Intervention Data Collection (Week 4)
Following the 4-week intervention period, all participants were undergone reassessment using the same measures collected at baseline:
- 1RM testing for back squat and bench press
- Muscular endurance tests (max repetition squat test and 1-minute push-up test)
- International Physical Activity Questionnaire (IPAQ)
- Conditions
- Sports Physical Therapy
- Being tested
- Heavy-Load Resistance Training with Blood Flow Restriction, Heavy-Load Resistance Training Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy-Load Resistance Training with Blood Flow RestrictionOther
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 OnlyOther
Heavy Load Resistance Training (HL-RT) is one of the most effective exercise methodology that is widely used to increase muscular strength and hypertrophy.
| Study group | Role | What they receive |
|---|---|---|
| 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: Receives: 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. Receives: Other: Heavy-Load Resistance Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start30 Jul 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion2 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Hassan, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128862
- Sponsor's protocol ID
- REC/RCR & AHS/24/0461
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heavy-load Resistance Training With and Without Blood Flow Restriction Therapy on Quadriceps Muscle Strength and Endurance in Athletes
- ClinicalTrials.gov ID
- NCT07128862
- Acronym / sponsor ID
- REC/RCR & AHS/24/0461
- Conditions
- Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-blinded randomized controlled trial (RCT) comparing heavy-load resistance training (HLRT) with blood flow restriction (BFR) versus HLRT alone. Participants will be blinded to group allocation, but outcome assessors will not remain blinded throughout the study.
Group A 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:
- Back squats: 4 sets of 6 repetitions
- Leg press: 3 sets of 8 repetitions
- Bench press: 3 sets of 10 repetitions All sets will be followed by a standardized 2-minute rest period. Training load will progressively increased by 2.5-5% when participants can complete all prescribed repetitions with proper form for two consecutive sessions.
Group B: Heavy-Load Resistance Training Only (HLRT) 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.
Post-Intervention Data Collection (Week 4)
Following the 4-week intervention period, all participants were undergone reassessment using the same measures collected at baseline:
- 1RM testing for back squat and bench press
- Muscular endurance tests (max repetition squat test and 1-minute push-up test)
- International Physical Activity Questionnaire (IPAQ)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Heavy-Load Resistance Training with Blood Flow Restriction | Experimental | Other: Heavy-Load Resistance Training with Blood Flow RestrictionIn 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: |
| Heavy-Load Resistance Training Only (HLRT) | Experimental | Other: Heavy-Load Resistance Training OnlyThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heavy-Load Resistance Training with Blood Flow RestrictionBlood 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. | Other | Heavy-Load Resistance Training with Blood Flow Restriction |
| Heavy-Load Resistance Training OnlyHeavy Load Resistance Training (HL-RT) is one of the most effective exercise methodology that is widely used to increase muscular strength and hypertrophy. | Other | Heavy-Load Resistance Training Only (HLRT) |
Primary outcome
1RM strength
Time frame: 6 weeks
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.
Squat Endurance
Time frame: 6 weeks
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.
Push Up Performance
Time frame: 6 weeks
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
International Physical Activity Questionnaire (IPAQ) scores
Time frame: 6 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Hassan, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy-Load Resistance Training with Blood Flow Restriction and Heavy-Load Resistance Training Only in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd PT (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1RM strength (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.