NCT07585305

Brief 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. 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.

Trial Health

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Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress18%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

May 18, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

May 7, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Patellofemoral painBlood flow restriction trainingQuadriceps strengthAthletic Performanceresistance training

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Baseline (Week 0) and Post-intervention (Week 8)

Secondary Outcomes (1)

  • Functional Outcomes - Kujala Anterior Knee Pain Scale (AKPS)

    Baseline (Week 0) and Post-intervention (Week 8)

Study Arms (2)

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.

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.

Device: Blood Flow Restriction Cycling

Interventions

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.

BFR Resistance Training Group

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.

BFR Cycling Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibadat International University, Islamabad (Iiui)

Islamabad, 46000, Pakistan

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Hafsah Gul Khattak, DPT, MS-NMPT

    IBADAT INTERNATIONAL UNIVERSITY, ISLAMABAD (IIUI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haroon Khan, MS. Sports Physical Therapy

CONTACT

Hafsah Gul Khattak, DPT, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blinded study in which the outcome assessor is blinded to group allocation. Participants and treating physiotherapists are aware of the assigned intervention due to the nature of exercise-based rehabilitation. Efforts are made to standardize instructions and interaction across both groups to minimize bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

May 18, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations