Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy
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|ClinicalTrials.gov Identifier: NCT04550013|
Recruitment Status : Recruiting
First Posted : September 15, 2020
Last Update Posted : September 15, 2020
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessor will be blinded to intervention allocation|
|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|
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%
- 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.
- 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)
- 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 ]
- 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
- 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
- Tendon thickness measured using Ultrasonography [ Time Frame: Baseline, 3, 6 and 12 weeks + 1 year follow-up ]
- 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
- Muscle structure measured by MRI [ Time Frame: Baseline and 12 weeks ]
- Tendon dimensions measured by MRI [ Time Frame: Baseline and 12 weeks ]
- 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
- 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.
- 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
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
|Contact: Mikkel Holm Hjortshøj Jensen, MScfirstname.lastname@example.org|
|Contact: Christian Couppé, Ph.D.||email@example.com|
|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 firstname.lastname@example.org|
|Contact: Christian Couppé, Ph.D. email@example.com|
|Principal Investigator:||Mikkel Holm Hjortshøj Jensen, MSc||Bispebjerg Hospital|