Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy

NCT05241197 | Recruiting

• 1 other identifier: BFR and Achilles Tendinopathy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achilles Tendinopathy; Achilles Tendon Pain; Tendon Injuries

Keywords

Blood Flow Restriction; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change on thickness of the Achilles tendon

  At baseline and 12 weeks

• Change on cross sectional area of the Achilles tendon

  At baseline and 12 weeks

• Change on neovascularization of the Achilles tendon

  At baseline and 12 weeks

• Change on single leg vertical jump

  At baseline, then at 6 and 12 weeks

• Change on single leg calf-raise endurance test

  At baseline, then at 6 and 12 weeks

Study Arms (2)

Low load training with blood flow restriction (LL-BFR) group.

EXPERIMENTAL

All participants in this arm will use a BFR tourniquet system during the execution of two exercises, unilateral dynamic standing and sitting calf-raises, with a training load of 20% 1 repetition maximum (RM), being progressively increased by 5% every four weeks. Dynamic strength testing will be implemented to re-evaluate the current strength level and adequately adjust the load, using the PowerLift app, which was validated by Balsalobre-Fernandez in 2017. For each exercise, each participant will perform four sets with 30 repetitions the first set and 15 repetitions in the subsequent three sets, counting a total of 75 repetitions. All exercises will be performed in full range of motion (full plantar flexion to full dorsal flexion), with an interset rest period of 1 minute. Three minutes rest was provided between exercises.

Other: Low Load Training with Blood Flow Restriction

High load training (HLT) group.

ACTIVE COMPARATOR

The HLT group will performed the same exercises than the BFR group, however 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. Dynamic strength testing will be implemented to re-evaluate the current strength level and adequately adjust the load, using the PowerLift app, which was validated by Balsalobre-Fernandez in 2017. All exercises will be performed in full range of motion, with an interset rest period of 1 minute and a rest period between exercises of 3 minutes.

Other: High Load Training

Interventions

Low Load Training with Blood Flow Restriction OTHER

A 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.

Low load training with blood flow restriction (LL-BFR) group.

High Load Training OTHER

All 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.

High load training (HLT) group.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Related Publications (3)

• Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig 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). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.

  PMID: 31725362 RESULT

• Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer 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: 10.1177/0363546515584760. Epub 2015 May 27.

  PMID: 26018970 RESULT

• 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: 10.1136/bjsports-2018-099934. Epub 2019 Jan 13.

  PMID: 30636702 RESULT

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Gonzalo Elias, PT

  University of Gran Rosario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Elias, PT

CONTACT

543416051190; gelias@ugr.edu.ar

Leonardo Intelangelo, MSc, PT

CONTACT

543416758135

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: April 29, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

AR (1)