NCT04550013

Brief Summary

The purpose of this study is to investigate the clinical and functional outcome of a 12-week rehabilitation regime consisting of Low-Load Blood Flow Restriction compared to Heavy-Slow Resistance training in male patients with chronic unilateral patellar tendinopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

August 20, 2020

Last Update Submit

January 17, 2023

Conditions

Patellar TendinopathyJumper's Knee

Keywords

Patellar tendinopathyOveruse InjuryRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline - 12 weeks using the clinical functional test Single-Leg Decline Squat measured on the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)

    Single-Leg Decline Squat is a reliable patellar tendon pain provocation test used to assess pain during function.

    Baseline-12 weeks.

Secondary Outcomes (12)

  • Single-Leg Decline Squat test

    Baseline, 3, 6 weeks + 1 year follow-up

  • Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.

    Baseline, 3, 6 and 12 weeks + 1 year follow-up

  • Self-reported activity level of sporting activities (hours/week)

    Baseline, 3, 6 and 12 weeks + 1 year follow-up

  • Doppler activity using Ultrasonography power Doppler

    Baseline, 3, 6 and 12 weeks + 1 year follow-up

  • Tendon thickness measured using Ultrasonography

    Baseline, 3, 6 and 12 weeks + 1 year follow-up

  • +7 more secondary outcomes

Study Arms (2)

Heavy-Slow Resistance training

ACTIVE COMPARATOR

Heavy-Slow Resistance training. Three times weekly for 12 weeks.

Other: Heavy-Slow Resistance training

Low-Load Blood Flow Restriction training

EXPERIMENTAL

Low-Load Blood Flow Restriction training. Three times weekly for 12 weeks

Other: Low-Load Blood Flow Restriction training

Interventions

Heavy-Slow Resistance trainingOTHER

Resistance training for knee extensors. The exercise will be performed at 80% of 1 RM and slowly (6 s/repetition).

Heavy-Slow Resistance training
Low-Load Blood Flow Restriction trainingOTHER

Resistance training for knee extensors. The exercise will be performed at 30% of 1 RM and with a relative Artery Occlusion Pressure of 80%

Low-Load Blood Flow Restriction training

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral patellar tendinopathy
  • Chronic (symptoms \>3 months)
  • Pain of ≥ 4 during preferred sporting activity on the numerical pain rating scale (NRS; with 0 being no pain and 10 being the worst imaginable pain)
  • Ultrasonographical tendon swelling
  • Ultrasonographical hypo-echoic area with doppler

You may not qualify if:

  • Bilateral tendinopathy
  • Cardiovascular diseases
  • Diabetes
  • Smoking
  • Previous surgery or trauma to the knee joint with an effect on the presenting clinical condition
  • Participants must not have been enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three months
  • Previous corticosteroid injection for patellar tendinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • Hjortshoej MH, Juneja H, Svensson RB, Herzog RB, Lundgaard-Nielsen M, Nielsen FK, Wulff MW, Olsen AE, Nybing JD, Hansen P, Petersen J, Kjaer M, Aagaard P, Magnusson SP, Couppe C. Effect of Low-Load Blood-Flow Restricted Training Versus Heavy Slow Resistance Training in Unilateral Patellar Tendinopathy: A Randomized Clinical Trial. Scand J Med Sci Sports. 2025 Dec;35(12):e70186. doi: 10.1111/sms.70186.

    PMID: 41452311DERIVED

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Mikkel Holm Hjortshøj Jensen, MSc

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to intervention allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2020

First Posted

September 16, 2020

Study Start

August 1, 2020

Primary Completion

December 30, 2022

Study Completion

September 23, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)