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Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550013
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 15, 2020
Sponsor:
Collaborators:
University College Absalon
Danske Fysioterapeuter
Information provided by (Responsible Party):
Mikkel Holm Hjortshøj Jensen, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Patellar Tendinopathy Jumper's Knee Other: Heavy-Slow Resistance training Other: Low-Load Blood Flow Restriction training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor will be blinded to intervention allocation
Primary Purpose: Treatment
Official Title: The Effect of Low-Load Resistance Training With Blood Flow Restriction for Treatment of Chronic Patellar Tendinopathy - A Randomized Clinical Trial
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : August 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

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%




Primary Outcome Measures :
  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) [ Time Frame: Baseline-12 weeks. ]
    Single-Leg Decline Squat is a reliable patellar tendon pain provocation test used to assess pain during function.


Secondary Outcome Measures :
  1. Single-Leg Decline Squat test [ Time Frame: Baseline, 3, 6 weeks + 1 year follow-up ]
    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)

  2. 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 ]
  3. Self-reported activity level of sporting activities (hours/week) [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
    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

  4. Doppler activity using Ultrasonography power Doppler [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
    Using Ultrasonography, we will measure Doppler activity within the affected tendon and use ImageJ for the analysis

  5. Tendon thickness measured using Ultrasonography [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
  6. Muscle cross-sectional area measured using Ultrasonography [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
    We will measure the muscle thickness of vastus lateralis using ultrasonography

  7. Muscle structure measured by MRI [ Time Frame: Baseline and 12 weeks ]
  8. Tendon dimensions measured by MRI [ Time Frame: Baseline and 12 weeks ]
  9. Isometric Muscle Strength [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
    Maximal muscle strength of the knee extensors is obtained during a maximal isometric voluntary contractions

  10. Pain Pressure Threshold [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
    Measured by a handheld pressure algometry at most painful site, Apex Patellar, Tibialis Anterior and Extensor Carpi Radialis.

  11. Adverse events [ Time Frame: Baseline-12 weeks + 1 year follow-up ]
    Participants will self-report adverse events during intervention period and at 1 year follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550013


Contacts
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Contact: Mikkel Holm Hjortshøj Jensen, MSc +4523611394 mikkel.holm.hjortshoej.jensen@regionh.dk
Contact: Christian Couppé, Ph.D. christian.couppe@regionh.dk

Locations
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Denmark
Department of Physical and Occupational Therapy / Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Mikkel Holm Hjortshøj Jensen, MSc    +45 23611394    mikkel.holm.hjortshoej.jensen@regionh.dk   
Contact: Christian Couppé, Ph.D.       christian.couppe@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
University College Absalon
Danske Fysioterapeuter
Investigators
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Principal Investigator: Mikkel Holm Hjortshøj Jensen, MSc Bispebjerg Hospital
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Responsible Party: Mikkel Holm Hjortshøj Jensen, Principal Investigator, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04550013    
Other Study ID Numbers: A2359
First Posted: September 15, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mikkel Holm Hjortshøj Jensen, Bispebjerg Hospital:
Patellar tendinopathy
Overuse Injury
Rehabilitation
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries