Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Gran Rosario
About this trial
Midportion Achilles tendinopathy (MAT) is a common overuse injury of the lower extremity characterized by the presence of pain, restricted function and interruption of sport activities. Conservative management of MAT has been suggested as the first line of treatment. Actually, there are several exercise programs with beneficial effects on pain and function among which high load training stands out. However, this training modality is inherently difficult to implement in certain populations and pathological conditions due to their inability to tolerate this mechanical stress. In this sense, low load training with blood flow restriction (BFR-LLT) emerges as an effective option in producing hypertrophic adaptations with low intensities (30% 1RM). However, this training modality has not yet been studied in tendon pathology. The aim of this study is to evaluate the potential clinical effects of BFR-LLT in comparison with HLT in patients with chronic MAT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of unilateral MAT.
Achilles pain > 3 months.
Age ranging between 18 to 50 years, both genders.
Read and speak Spanish well enough to provide informed consent and follow study instructions.
Disqualifiers
Any ankle or foot surgery.
History of Achilles rupture.
Heel pain in the last 3 months.
Systemic disorders/diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Low Load Training with Blood Flow Restriction
Other interventionA 12-cm-wide pneumatic nylon tourniquet will be proximally positioned with a snug fit on each thigh. Previously, arterial occlusion pressure (AOP) will be determined using a handheld Doppler Ultrasound in a standing position for each participant. For training routines, cuff pressure will be set to 50% of each individual´s AOP and will be keep inflated during the entire session including the interset rest period of 1 minute. Between the two exercises, the cuff will be deflated for 3 minutes.
High Load Training
Other interventionAll participants in this arm will do two exercises, unilateral dynamic standing and sitting calf-raises, with a training load of 70% 1RM, being progressively increased by 5% every four weeks from 70% to 80%. This protocol will consist of three sets of 6-12 repetitions with a interset rest period of 1 minute and 3 minutes rest between exercises.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Low load training with blood flow restriction (LL-BFR) group.Experimental treatment 1 intervention
Group B: High load training (HLT) group.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change on pain intensity
The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity in daily and sport activities. This scale consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Time frame
At baseline, then at 6 and 12 weeks2
Change on Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
This questionnaire will be used to assess the symptoms, function and pain during daily living and sport activities. The VISA-A consists of 8 questions in which the patients rate the magnitude of pain during rest, function, and activity. The maximum score is 100 points, and a lower score indicates more symptoms and a greater limitation of function and activity.
Time frame
At baseline, then at 6 and 12 weeksSecondary outcomes
1
Change on thickness of the Achilles tendon
Real time ultrasonography will be performed on the injured Achilles tendon in a longitudinal plane. The thickest point of the tendon will be identified and the A-P distance will be measured (12MHZ linear transducer; Toshiba Aplio300).
Time frame
At baseline and 12 weeks2
Change on cross sectional area of the Achilles tendon
Real time ultrasonography will be performed on the injured Achilles tendon in a transverse plane. The thickest point of the tendon will be identified and the A-P distance will be measured (12MHZ linear transducer; Toshiba Aplio300).
Time frame
At baseline and 12 weeks3
Change on neovascularization of the Achilles tendon
Real time ultrasonography with PowerDoppler will be performed in a longitudinal and transverse planes (12MHZ linear transducer; Toshiba Aplio300).
Time frame
At baseline and 12 weeks4
Change on single leg vertical jump
This test will assess the height in cm, power, strength, velocity and flight time of a vertical jump using the My Jump app, validated by Gallardo-Fuentes in 2016. The instructions will be jumping as high as possible with hands on the subject's waist. Participants will perform 3 repetitions in a non-consecutive manner.
Time frame
At baseline, then at 6 and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov