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Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

The Effect of Low-Load Resistance Training With Blood Flow Restriction for Treatment of Chronic Patellar Tendinopathy - A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04550013
Enrollment
36
Registered
2020-09-16
Start date
2020-08-01
Completion date
2023-09-23
Last updated
2023-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jumper's Knee, Patellar Tendinopathy

Keywords

Patellar tendinopathy, Overuse Injury, Rehabilitation

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.

Detailed description

Chronic tendinopathy represents a considerable problem in both elite and recreational athletes, and symptoms may affect athletic performance and reduce or even result in retirement from sports participation. The current best treatment is considered to be heavy-slow resistance training (HSRT); however, not all patients are able to cope with heavy exercise loads. Therefore, low-load strength training performed under partial blood flow restriction may be a clinically relevant rehabilitation tool. This project aims to investigate a new innovative intervention to treat chronic unilateral patellar tendinopathy in male individuals using strength training with low-load muscle contractions performed under partial blood flow restriction (LL-BFR), and to compare the resulting treatment outcome to that of the current best practice (HSRT). Specifically, the effect of LL-BFR will be investigated using a randomized controlled trial design with two groups; 1) a low-load blood flow restriction training program, and 2) a heavy-load slow strength training program. A total sample size of 36 participants are needed when assuming a 10 % dropout. The training protocol consist of three weekly training sessions during a 12-week rehabilitation period. The primary outcome is measured using the Single-Leg Decline Squat at 12-week. If LL-BFR proves to be an effective treatment strategy for tendinopathy, it can easily be implemented in daily clinical practice.

Interventions

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

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

Sponsors

University College Absalon
CollaboratorOTHER
Danske Fysioterapeuter
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor will be blinded to intervention allocation

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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)Baseline-12 weeks.Single-Leg Decline Squat is a reliable patellar tendon pain provocation test used to assess pain during function.

Secondary

MeasureTime frameDescription
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-upParticipants will self-report how many hours a week they are performing sporting activities: We will monitor to see if they decrease, maintain or increase hours per week of sporting activity
Doppler activity using Ultrasonography power DopplerBaseline, 3, 6 and 12 weeks + 1 year follow-upUsing Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
Tendon thickness measured using UltrasonographyBaseline, 3, 6 and 12 weeks + 1 year follow-up
Muscle cross-sectional area measured using UltrasonographyBaseline, 3, 6 and 12 weeks + 1 year follow-upWe will measure the muscle thickness of vastus lateralis using ultrasonography
Single-Leg Decline Squat testBaseline, 3, 6 weeks + 1 year follow-upA reliable patellar tendon pain provocation test, will be used to assess pain during function using the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
Tendon dimensions measured by MRIBaseline and 12 weeks
Isometric Muscle StrengthBaseline, 3, 6 and 12 weeks + 1 year follow-upMaximal muscle strength of the knee extensors is obtained during a maximal isometric voluntary contractions
Pain Pressure ThresholdBaseline, 3, 6 and 12 weeks + 1 year follow-upMeasured by a handheld pressure algometry at most painful site, Apex Patellar, Tibialis Anterior and Extensor Carpi Radialis.
Adverse eventsBaseline-12 weeks + 1 year follow-upParticipants will self-report adverse events during intervention period and at 1 year follow-up
Victorian Institute of Sports Assessment - Patellar TendinopathyBaseline, 3, 6 and 12 weeks + 1 year follow-upThe VISA-P is a questionnaire that assesses symptoms, simple test of function, and the ability to play sports. Max score for asymptomatic is 100 and worst score is 0
Muscle structure measured by MRIBaseline and 12 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026