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Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

Primary Purpose

Patellar Tendinopathy, Jumper's Knee

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Heavy-Slow Resistance training
Low-Load Blood Flow Restriction training
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellar Tendinopathy focused on measuring Patellar tendinopathy, Overuse Injury, Rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Heavy-Slow Resistance training

Low-Load Blood Flow Restriction training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
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
Doppler activity using Ultrasonography power Doppler
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
Tendon thickness measured using Ultrasonography
Muscle cross-sectional area measured using Ultrasonography
We will measure the muscle thickness of vastus lateralis using ultrasonography
Muscle structure measured by MRI
Tendon dimensions measured by MRI
Isometric Muscle Strength
Maximal muscle strength of the knee extensors is obtained during a maximal isometric voluntary contractions
Pain Pressure Threshold
Measured by a handheld pressure algometry at most painful site, Apex Patellar, Tibialis Anterior and Extensor Carpi Radialis.
Adverse events
Participants will self-report adverse events during intervention period and at 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

Full Information

First Posted
August 20, 2020
Last Updated
January 17, 2023
Sponsor
Bispebjerg Hospital
Collaborators
University College Absalon, Danske Fysioterapeuter
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1. Study Identification

Unique Protocol Identification Number
NCT04550013
Brief Title
Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy
Official Title
The Effect of Low-Load Resistance Training With Blood Flow Restriction for Treatment of Chronic Patellar Tendinopathy - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
September 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
University College Absalon, Danske Fysioterapeuter

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy, Jumper's Knee
Keywords
Patellar tendinopathy, Overuse Injury, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blinded to intervention allocation
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heavy-Slow Resistance training
Arm Type
Active Comparator
Arm Description
Heavy-Slow Resistance training. Three times weekly for 12 weeks.
Arm Title
Low-Load Blood Flow Restriction training
Arm Type
Experimental
Arm Description
Low-Load Blood Flow Restriction training. Three times weekly for 12 weeks
Intervention Type
Other
Intervention Name(s)
Heavy-Slow Resistance training
Intervention Description
Resistance training for knee extensors. The exercise will be performed at 80% of 1 RM and slowly (6 s/repetition).
Intervention Type
Other
Intervention Name(s)
Low-Load Blood Flow Restriction training
Intervention Description
Resistance training for knee extensors. The exercise will be performed at 30% of 1 RM and with a relative Artery Occlusion Pressure of 80%
Primary Outcome Measure Information:
Title
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)
Description
Single-Leg Decline Squat is a reliable patellar tendon pain provocation test used to assess pain during function.
Time Frame
Baseline-12 weeks.
Secondary Outcome Measure Information:
Title
Single-Leg Decline Squat test
Description
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)
Time Frame
Baseline, 3, 6 weeks + 1 year follow-up
Title
Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Self-reported activity level of sporting activities (hours/week)
Description
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
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Doppler activity using Ultrasonography power Doppler
Description
Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Tendon thickness measured using Ultrasonography
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Muscle cross-sectional area measured using Ultrasonography
Description
We will measure the muscle thickness of vastus lateralis using ultrasonography
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Muscle structure measured by MRI
Time Frame
Baseline and 12 weeks
Title
Tendon dimensions measured by MRI
Time Frame
Baseline and 12 weeks
Title
Isometric Muscle Strength
Description
Maximal muscle strength of the knee extensors is obtained during a maximal isometric voluntary contractions
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Pain Pressure Threshold
Description
Measured by a handheld pressure algometry at most painful site, Apex Patellar, Tibialis Anterior and Extensor Carpi Radialis.
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up
Title
Adverse events
Description
Participants will self-report adverse events during intervention period and at 1 year follow-up
Time Frame
Baseline-12 weeks + 1 year follow-up
Title
Victorian Institute of Sports Assessment - Patellar Tendinopathy
Description
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
Time Frame
Baseline, 3, 6 and 12 weeks + 1 year follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Holm Hjortshøj Jensen, MSc
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

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