Achilles Tendinopathy Clinical Trial
Official title:
Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | August 2024 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 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. - Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks. Exclusion Criteria: - Any ankle or foot surgery. - History of Achilles rupture. - Heel pain in the last 3 months. - Systemic disorders/diseases. - History of deep venous thrombosis, hypertension or blood clotting disorder. - Body mass index > 30kg/m2. - Self-report of pregnancy. - Drug use (local steroid injection or systemic fluoroquinolones). - Pain < 2/10 of average pain on NPRS. - VISA A score > 90%. - Unable to perform any of the exercises of the study. |
Country | Name | City | State |
---|---|---|---|
Argentina | University of Gran Rosario | Rosario | Santa Fe |
Lead Sponsor | Collaborator |
---|---|
University of Gran Rosario |
Argentina,
Beyer R, Kongsgaard M, Hougs Kjær B, Øhlenschlæger T, Kjær M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/036354 — View Citation
Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, König D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985 — View Citation
Murphy MC, Travers MJ, Chivers P, Debenham JR, Docking SI, Rio EK, Gibson W. Efficacy of heavy eccentric calf training for treating mid-portion Achilles tendinopathy: a systematic review and meta-analysis. Br J Sports Med. 2019 Sep;53(17):1070-1077. doi: — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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". | At baseline, then at 6 and 12 weeks | |
Primary | 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. | At baseline, then at 6 and 12 weeks | |
Secondary | 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). | At baseline and 12 weeks | |
Secondary | 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). | At baseline and 12 weeks | |
Secondary | 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). | At baseline and 12 weeks | |
Secondary | 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. | At baseline, then at 6 and 12 weeks | |
Secondary | Change on single leg calf-raise endurance test | This test will assess height, power and work of the calf raise performance during the heel elevation using the Calf Raise app. The test involves going up on the toes and back down as many times the participant can. The test has excellent reliability and is able to detect side-to-side deficits. Participant will be encourage to perform the maximal repetitions during one minute. | At baseline, then at 6 and 12 weeks |
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