NCT07600827

Brief Summary

This randomized controlled trial aims to investigate the effects of isokinetic training combined with blood flow restriction (BFR) in individuals with patellofemoral pain syndrome (PFPS).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

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 Progress91%
Feb 2026Jun 2026

Study Start

First participant enrolled

February 25, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anterior Knee Pain Scale (AKPS)

    The AKPS is a validated questionnaire used to assess pain and functional limitations associated with patellofemoral pain syndrome. Scores range from 0 to 100, with higher scores indicating better knee function and fewer symptoms.

    From enrollment to the end of treatment at 4 weeks

Study Arms (3)

IT+BFR group

EXPERIMENTAL

Isokinetic Training Combined With Blood Flow Restriction

Device: Isokinetic Training Combined With Blood Flow Restriction

IT group

ACTIVE COMPARATOR

Isokinetic Training

Device: Isokinetic Training

ACE group

ACTIVE COMPARATOR

Aerobic Cycling Exercise

Device: Aerobic Cycling Exercise

Interventions

Participants in this group will receive supervised isokinetic muscle strength training targeting the knee musculature using an isokinetic dynamometer. Each session will last 30 minutes throughout the intervention period.

IT group

Participants in this group will receive isokinetic muscle strength training combined with blood flow restriction (BFR). BFR will be applied to the proximal thigh using a pneumatic cuff at an individualized pressure based on limb occlusion pressure. Isokinetic training will target the knee musculature using an isokinetic dynamometer under supervised conditions. Each session will last 30 minutes, with training performed multiple times per week throughout the intervention period.

IT+BFR group

Participants in this group will receive supervised aerobic cycling exercise using a stationary bicycle. Training will be performed at a moderate intensity for 30 minutes per session throughout the intervention period.

ACE group

Eligibility Criteria

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

You may qualify if:

  • Participants aged 18 to 40 years.
  • Clinical diagnosis of patellofemoral pain syndrome (PFPS).
  • Presence of anterior or retropatellar knee pain for at least 3 months.
  • Pain provoked by at least two activities that increase patellofemoral joint load, including squatting, stair climbing, running, jumping, prolonged sitting, or kneeling.
  • Average knee pain intensity of ≥3 on a 10-point visual analog scale (VAS) during aggravating activities.
  • Ability to participate in exercise training and attend scheduled intervention sessions.
  • Willingness to provide written informed consent.

You may not qualify if:

  • History of knee surgery or significant trauma to the lower extremity within the previous 12 months.
  • Clinical evidence of other knee disorders, including ligament injury, meniscal injury, patellar instability, osteoarthritis, or tendinopathy.
  • Presence of neurological, cardiovascular, or systemic musculoskeletal disorders that may affect lower limb function or exercise participation.
  • Current participation in other structured lower extremity rehabilitation or strength training programs.
  • Contraindications to blood flow restriction training, including uncontrolled hypertension, vascular disease, thromboembolic disorders, or clotting abnormalities.
  • Use of pain-relieving injections or surgical interventions for knee pain within the previous 6 months.
  • Pregnancy.
  • Inability to complete the assessment or intervention procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Mingzhou Rehabilitation Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Zhang

    Nanjing Mingzhou Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor Technician

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations