Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

NCT ID: NCT04550013

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2023-09-23

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.

Conditions

Patellar Tendinopathy; Jumper's Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Heavy-Slow Resistance training

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

Group Type: ACTIVE_COMPARATOR

Heavy-Slow Resistance training

Intervention Type: OTHER

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

Low-Load Blood Flow Restriction training

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

Group Type: EXPERIMENTAL

Low-Load Blood Flow Restriction training

Intervention Type: OTHER

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

Interventions

Heavy-Slow Resistance training

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

Intervention Type: 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%

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University College Absalon

OTHER

Sponsor Role: collaborator

Danske Fysioterapeuter

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mikkel Holm Hjortshøj Jensen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikkel Holm Hjortshøj Jensen, MSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

A2359

Identifier Type: -

Identifier Source: org_study_id