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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Jumper's Knee; Patellar Tendinopathy
• Intervention / Treatment: Other: Heavy-Slow Resistance training; Other: Low-Load Blood Flow Restriction training

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heavy-Slow Resistance training; Heavy-Slow Resistance training. Three times weekly for 12 weeks.	Other: Heavy-Slow Resistance training; Resistance training for knee extensors. The exercise will be performed at 80% of 1 RM and slowly (6 s/repetition).
Experimental: Low-Load Blood Flow Restriction training; Low-Load Blood Flow Restriction training. Three times weekly for 12 weeks	Other: Low-Load Blood Flow Restriction training; Resistance training for knee extensors. The exercise will be performed at 30% of 1 RM and with a relative Artery Occlusion Pressure of 80%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-Leg Decline Squat test	A 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)	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)	Participants 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	Baseline, 3, 6 and 12 weeks + 1 year follow-up
Doppler activity using Ultrasonography power Doppler	Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis	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
Muscle cross-sectional area measured using Ultrasonography	We will measure the muscle thickness of vastus lateralis using ultrasonography	Baseline, 3, 6 and 12 weeks + 1 year follow-up
Muscle structure measured by MRI		Baseline and 12 weeks
Tendon dimensions measured by MRI		Baseline and 12 weeks
Isometric Muscle Strength	Maximal muscle strength of the knee extensors is obtained during a maximal isometric voluntary contractions	Baseline, 3, 6 and 12 weeks + 1 year follow-up
Pain Pressure Threshold	Measured by a handheld pressure algometry at most painful site, Apex Patellar, Tibialis Anterior and Extensor Carpi Radialis.	Baseline, 3, 6 and 12 weeks + 1 year follow-up
Adverse events	Participants will self-report adverse events during intervention period and at 1 year follow-up	Baseline-12 weeks + 1 year follow-up
Victorian Institute of Sports Assessment - Patellar Tendinopathy	The 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	Baseline, 3, 6 and 12 weeks + 1 year follow-up

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: University College Absalon; Danske Fysioterapeuter
• Investigators: Principal Investigator: Mikkel Holm Hjortshøj Jensen, MSc, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Anticipated): September 23, 2023

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Overuse Injury; Patellar tendinopathy
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: A2359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No