Patello Femoral Pain SyndromeBFR-PFP-RCTNCT07585305
Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain
A study testing Blood Flow Restriction Resistance Training and Blood Flow Restriction Cycling in people with Patello Femoral Pain Syndrome, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial summary
This randomized controlled trial compares blood flow restriction (BFR) resistance training (leg press and seated knee extension at 30% 1RM) versus BFR cycling (stationary cycling at low resistance) in 60 athletes (aged 18-40 years) diagnosed with patellofemoral pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patello Femoral Pain Syndrome
- What is being tested?
- Blood Flow Restriction Resistance Training and Blood Flow Restriction Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 25 Jul 2026
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female athletes aged 18-40 years
- Clinically diagnosed with patellofemoral pain syndrome
- Anterior or retropatellar knee pain of at least 3 months duration
- Pain provoked by at least two functional activities (e.g., squatting, stair climbing, running, prolonged sitting)
- Willingness to participate and provide written informed consent
Who cannot join
- History of knee surgery or significant knee trauma in the past 6 months
- Presence of ligament, meniscal, or cartilage injuries
- Neurological, vascular, or systemic inflammatory conditions
- Contraindications to BFR training (e.g., deep vein thrombosis, uncontrolled hypertension)
- Pregnancy
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
Ibadat International University, Islamabad (Iiui)
Islamabad, 46000
Hafsah Gul Khattak, DPT, MS-NMPT, 923457170732, hafsahgull_khattak@yahoo.com
About this study
Official title: Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain: A Randomized Controlled Trial
This randomized controlled trial compares blood flow restriction (BFR) resistance training (leg press and seated knee extension at 30% 1RM) versus BFR cycling (stationary cycling at low resistance) in 60 athletes (aged 18-40 years) diagnosed with patellofemoral pain syndrome. Both interventions are delivered over 8 weeks (3 sessions/week) with a pneumatic cuff set at 80% limb occlusion pressure. Primary outcomes include pain intensity (NPRS), quadriceps strength (handheld dynamometer), and functional ability (Kujala Anterior Knee Pain Scale), assessed at baseline and post-intervention.
Read the detailed description
Patellofemoral pain (PFP) is among the most prevalent musculoskeletal conditions in athletes, with reported prevalence of 30-40% in sports populations. High-load resistance training is the conventional rehabilitation approach but often exacerbates joint stress and reduces adherence. Blood flow restriction (BFR) training enables strength gains at low loads by applying a pneumatic cuff at 80% LOP on the proximal thigh.
This trial compares two BFR modalities:
- Group A (BFR-RT): Leg press and seated knee extension, 1x30 + 3x15 reps at 30% 1RM, 3x/week for 8 weeks.
- Group B (BFR-CYC): Stationary cycling at low resistance, 4x5-minute intervals at 70-80 RPM (RPE 11-13), 3x/week for 8 weeks.
All sessions are supervised one-on-one by a physiotherapist. Assessments are conducted at baseline and week 8. The study is single-blinded (outcome assessor blinded). Randomization via computer-generated sequence. Statistical analysis via SPSS v27 (paired t-test / Wilcoxon for within-group; independent t-test / Mann-Whitney for between-group, alpha=0.05).
- Conditions
- Patello Femoral Pain Syndrome
- Being tested
- Blood Flow Restriction Resistance Training, Blood Flow Restriction Cycling
- Keywords
- Patellofemoral pain, Blood flow restriction training, Quadriceps strength, Athletic Performance, resistance training
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction Resistance TrainingDevice
Participants will undergo blood flow restriction (BFR) resistance training using a pneumatic cuff applied to the proximal thigh at 80% limb occlusion pressure. Exercises include leg press and seated knee extension performed at 30% of one-repetition maximum (1RM). Training will be conducted for 8 weeks, with supervised sessions 3 times per week. Cuff pressure will be monitored and adjusted using BP cuff. The aim is to improve quadriceps strength and reduce pain in patients with patellofemoral pain.
Blood Flow Restriction CyclingDevice
Participants will perform stationary cycling combined with blood flow restriction (BFR) applied to the proximal thigh at 80% limb occlusion pressure. Cycling will be performed at low resistance with controlled cadence for 8 weeks, 3 sessions per week under physiotherapist supervision. The protocol includes structured cycling intervals with rest periods and continuous monitoring of pain and perceived exertion. The intervention aims to improve quadriceps strength, reduce pain, and enhance functional outcomes in patients with patellofemoral pain.
| Study group | Role | What they receive |
|---|---|---|
| BFR Resistance Training Group | Active comparator | Participants perform leg press and seated knee extension exercises at 30% of 1RM with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% limb occlusion pressure (LOP). Protocol: 1 set of 30 + 3 sets of 15 repetitions, with 60-second rest between sets (cuff deflated). Frequency: 3 sessions/week for 8 weeks (24 sessions total). 1RM re-estimated every 2 weeks for progressive load adjustment. Warm-up: 10 min low-resistance cycling (no BFR). Cool-down: 5 min lower-limb stretching. Receives: Device: Blood Flow Restriction Resistance Training |
| BFR Cycling Group | Experimental | Participants perform stationary cycling at low resistance targeting RPE 11-13, with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% LOP. Protocol: 4 x 5-minute cycling intervals at 70-80 RPM, with 1-minute rest between intervals (cuff deflated). Frequency: 3 sessions/week for 8 weeks (24 sessions total). Cadence increased by 5 RPM if RPE <11. Warm-up: 10 min low-resistance cycling (no BFR). Cool-down: 5 min lower-limb stretching. Receives: Device: Blood Flow Restriction Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Strength - Handheld Dynamometer
Isometric quadriceps muscle strength measured in Newtons using a calibrated handheld dynamometer (ICC > 0.90). Measurement taken in a standardized seated position at 60° knee flexion.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Self-reported pain intensity rated on a 0-10 scale (0 = no pain, 10 = worst imaginable pain). The NPRS has excellent test-retest reliability (ICC 0.95).
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Secondary outcomes (1)
Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)
13-item patient-reported outcome measure assessing functional limitations due to anterior knee pain. Scored 0-100 (higher = better function). High internal consistency (α = 0.83-0.91).
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start10 May 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patello Femoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- This study is a parallel-group randomized controlled trial comparing two active intervention arms: blood flow restriction resistance training and blood flow restriction cycling in patients with patellofemoral pain.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsah Gul Khattak, Ibadat International University, Islamabad
- Investigators
- Hafsah Gul Khattak, DPT, MS-NMPT, Principal investigator, IBADAT INTERNATIONAL UNIVERSITY, ISLAMABAD (IIUI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585305
- Sponsor's protocol ID
- IIUI/RERC/ADT/2026/04/286
- Acronym
- BFR-PFP-RCT
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Blood Flow Restriction Resistance Training Versus Blood Flow Restriction Cycling on Pain, Quadriceps Strength, and Functional Outcomes in Athletes With Patellofemoral Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07585305
- Acronym / sponsor ID
- BFR-PFP-RCT / IIUI/RERC/ADT/2026/04/286
- Conditions
- Patello Femoral Pain Syndrome
- Keywords
- Patellofemoral pain, Blood flow restriction training, Quadriceps strength, Athletic Performance, resistance training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 13 May 2026 (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.
This randomized controlled trial compares blood flow restriction (BFR) resistance training (leg press and seated knee extension at 30% 1RM) versus BFR cycling (stationary cycling at low resistance) in 60 athletes (aged 18-40 years) diagnosed with patellofemoral pain syndrome. Both interventions are delivered over 8 weeks (3 sessions/week) with a pneumatic cuff set at 80% limb occlusion pressure. Primary outcomes include pain intensity (NPRS), quadriceps strength (handheld dynamometer), and functional ability (Kujala Anterior Knee Pain Scale), assessed at baseline and post-intervention.
Detailed description
Patellofemoral pain (PFP) is among the most prevalent musculoskeletal conditions in athletes, with reported prevalence of 30-40% in sports populations. High-load resistance training is the conventional rehabilitation approach but often exacerbates joint stress and reduces adherence. Blood flow restriction (BFR) training enables strength gains at low loads by applying a pneumatic cuff at 80% LOP on the proximal thigh.
This trial compares two BFR modalities:
- Group A (BFR-RT): Leg press and seated knee extension, 1x30 + 3x15 reps at 30% 1RM, 3x/week for 8 weeks.
- Group B (BFR-CYC): Stationary cycling at low resistance, 4x5-minute intervals at 70-80 RPM (RPE 11-13), 3x/week for 8 weeks.
All sessions are supervised one-on-one by a physiotherapist. Assessments are conducted at baseline and week 8. The study is single-blinded (outcome assessor blinded). Randomization via computer-generated sequence. Statistical analysis via SPSS v27 (paired t-test / Wilcoxon for within-group; independent t-test / Mann-Whitney for between-group, alpha=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a parallel-group randomized controlled trial comparing two active intervention arms: blood flow restriction resistance training and blood flow restriction cycling in patients with patellofemoral pain.
| Arm | Type | Receives |
|---|---|---|
| BFR Resistance Training Group | Active comparator | Device: Blood Flow Restriction Resistance TrainingParticipants perform leg press and seated knee extension exercises at 30% of 1RM with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% limb occlusion pressure (LOP). Protocol: 1 set of 30 + 3 sets of 15 repetitions, with 60-second rest between sets (cuff deflated). Frequency: 3 sessions/week for 8 weeks (24 sessions total). 1RM re-estimated every 2 weeks for progressive load adjustment. Warm-up: 10 min low-resistance cycling (no BFR). Cool-down: 5 min lower-limb stretching. |
| BFR Cycling Group | Experimental | Device: Blood Flow Restriction CyclingParticipants perform stationary cycling at low resistance targeting RPE 11-13, with a pneumatic cuff (12 cm wide, Delfi Medical) applied to the proximal thigh at 80% LOP. Protocol: 4 x 5-minute cycling intervals at 70-80 RPM, with 1-minute rest between intervals (cuff deflated). Frequency: 3 sessions/week for 8 weeks (24 sessions total). Cadence increased by 5 RPM if RPE <11. Warm-up: 10 min low-resistance cycling (no BFR). Cool-down: 5 min lower-limb stretching. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female athletes aged 18-40 years
- Clinically diagnosed with patellofemoral pain syndrome
- Anterior or retropatellar knee pain of at least 3 months duration
- Pain provoked by at least two functional activities (e.g., squatting, stair climbing, running, prolonged sitting)
- Willingness to participate and provide written informed consent
Key exclusion criteria (5 listed)
- History of knee surgery or significant knee trauma in the past 6 months
- Presence of ligament, meniscal, or cartilage injuries
- Neurological, vascular, or systemic inflammatory conditions
- Contraindications to BFR training (e.g., deep vein thrombosis, uncontrolled hypertension)
- Pregnancy
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 |
|---|---|---|
| Blood Flow Restriction Resistance TrainingParticipants will undergo blood flow restriction (BFR) resistance training using a pneumatic cuff applied to the proximal thigh at 80% limb occlusion pressure. Exercises include leg press and seated knee extension performed at 30% of one-repetition maximum (1RM). Training will be conducted for 8 weeks, with supervised sessions 3 times per week. Cuff pressure will be monitored and adjusted using BP cuff. The aim is to improve quadriceps strength and reduce pain in patients with patellofemoral pain. | Device | BFR Resistance Training Group |
| Blood Flow Restriction CyclingParticipants will perform stationary cycling combined with blood flow restriction (BFR) applied to the proximal thigh at 80% limb occlusion pressure. Cycling will be performed at low resistance with controlled cadence for 8 weeks, 3 sessions per week under physiotherapist supervision. The protocol includes structured cycling intervals with rest periods and continuous monitoring of pain and perceived exertion. The intervention aims to improve quadriceps strength, reduce pain, and enhance functional outcomes in patients with patellofemoral pain. | Device | BFR Cycling Group |
Primary outcome
Quadriceps Strength - Handheld Dynamometer
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Isometric quadriceps muscle strength measured in Newtons using a calibrated handheld dynamometer (ICC > 0.90). Measurement taken in a standardized seated position at 60° knee flexion.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Self-reported pain intensity rated on a 0-10 scale (0 = no pain, 10 = worst imaginable pain). The NPRS has excellent test-retest reliability (ICC 0.95).
1 secondary outcome
Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
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 26 Jun 2026.
- 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.
Hafsah Gul Khattak, DPT, MS-NMPT principal investigator
IBADAT INTERNATIONAL UNIVERSITY, ISLAMABAD (IIUI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Resistance Training and Blood Flow Restriction Cycling in people with Patello Femoral Pain Syndrome, run by Ibadat International University, Islamabad 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 5 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 26 Jun 2026. 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 Haroon Khan, MS. Sports Physical Therapy (+923000526711, haroonkhan2k00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Strength - Handheld Dynamometer (time frame: Baseline (Week 0) and Post-intervention (Week 8)). The study lists 2 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 26 Jun 2026.