Achilles TendinopathyNCT05241197
Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy
A study testing Low Load Training with Blood Flow Restriction and High Load Training in people with Achilles Tendinopathy and Achilles Tendon Pain, run by University of Gran Rosario at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Achilles Tendinopathy, Achilles Tendon Pain, Tendon Injuries
- What is being tested?
- Low Load Training with Blood Flow Restriction and High Load Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteArgentina
- Study dates
- 29 Apr 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leonardo Intelangelo, MSc, PT contact
Argentina1 site, 1 recruiting
- Recruiting
University of Gran Rosario
Rosario, Santa Fe Province, 2000
Gonzalo Elias, PT, 543416051190, gelias@ugr.edu.ar
Leonardo Intelangelo, MSc, PT, 543416758135
About this study
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.
Read the detailed description
The aim of this study will be to evaluate the potential clinical effects of low load training with blood flow restriction (BFR-LLT) in comparison with high load training (HLT) in patients with chronic midportion Achilles tendinopathy (MAT). The secondary objectives will be to determine if there are differences in the neovascularity and thickness, pain and function of the AT between both groups in each instance of evaluation. This study will be a simple-blinded randomized clinical trial comprising a total sample size of 52 participants with MAT of both genders and aged between 18 and 50 years. Subjects will undergo a screening process by a sports medicine doctor by different diagnostic tests to identify those presenting a diagnosis of painful MAT and then, they will be randomized into either a group performing HLT (G1), or a group performing BFR-LLT (G2). These volunteers will be recruited in the Parque Hospital (Rosario, Argentine). The study will assess the subjects tendon pain, thickness, cross sectional area and neovascularity, lower limb function, calf raise endurance and jump height. The training protocol will be performed in the University of Gran Rosario (Rosario, Argentine) and will consist of three weekly training sessions during a 12-week rehabilitation period. Primary and secondary outcomes will be measured at baseline, 6 and 12 weeks. All the evaluations will be performed by a blinded physiotherapist.
- Conditions
- Achilles Tendinopathy, Achilles Tendon Pain, Tendon Injuries
- Being tested
- Low Load Training with Blood Flow Restriction, High Load Training
- Keywords
- Blood Flow Restriction, Rehabilitation
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load Training with Blood Flow RestrictionOther
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.
High Load TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High Load Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: At baseline, then at 6 and 12 weeks
Secondary outcomes (5)
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).
Measured: At baseline and 12 weeks
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).
Measured: At baseline and 12 weeks
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).
Measured: At baseline and 12 weeks
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.
Measured: At baseline, then at 6 and 12 weeks
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.
Measured: At baseline, then at 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start29 Apr 2022
- Primary completionNov 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonzalo Elias, University of Gran Rosario
- Investigators
- Gonzalo Elias, PT, Principal investigator, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241197
- Sponsor's protocol ID
- BFR and Achilles Tendinopathy
- Status last verified
- Dec 2024
- First submitted
- 4 Feb 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31725362Beyer 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.
PubMed 26018970Murphy 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.
PubMed 30636702
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT05241197
- Acronym / sponsor ID
- BFR and Achilles Tendinopathy
- Conditions
- Achilles Tendinopathy, Achilles Tendon Pain, Tendon Injuries
- Keywords
- Blood Flow Restriction, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study will be to evaluate the potential clinical effects of low load training with blood flow restriction (BFR-LLT) in comparison with high load training (HLT) in patients with chronic midportion Achilles tendinopathy (MAT). The secondary objectives will be to determine if there are differences in the neovascularity and thickness, pain and function of the AT between both groups in each instance of evaluation. This study will be a simple-blinded randomized clinical trial comprising a total sample size of 52 participants with MAT of both genders and aged between 18 and 50 years. Subjects will undergo a screening process by a sports medicine doctor by different diagnostic tests to identify those presenting a diagnosis of painful MAT and then, they will be randomized into either a group performing HLT (G1), or a group performing BFR-LLT (G2). These volunteers will be recruited in the Parque Hospital (Rosario, Argentine). The study will assess the subjects tendon pain, thickness, cross sectional area and neovascularity, lower limb function, calf raise endurance and jump height. The training protocol will be performed in the University of Gran Rosario (Rosario, Argentine) and will consist of three weekly training sessions during a 12-week rehabilitation period. Primary and secondary outcomes will be measured at baseline, 6 and 12 weeks. All the evaluations will be performed by a blinded physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low load training with blood flow restriction (LL-BFR) group. | Experimental | Other: Low Load Training with Blood Flow RestrictionAll 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. |
| High load training (HLT) group. | Active comparator | Other: High Load TrainingThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Load Training with Blood Flow RestrictionA 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. | Other | Low load training with blood flow restriction (LL-BFR) group. |
| High Load TrainingAll 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. | Other | High load training (HLT) group. |
Primary outcome
Change on pain intensity
Time frame: At baseline, then at 6 and 12 weeks
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".
Change on Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
Time frame: At baseline, then at 6 and 12 weeks
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.
5 secondary outcomes
Change on thickness of the Achilles tendon
Time frame: At baseline and 12 weeks
Change on cross sectional area of the Achilles tendon
Time frame: At baseline and 12 weeks
Change on neovascularization of the Achilles tendon
Time frame: At baseline and 12 weeks
Change on single leg vertical jump
Time frame: At baseline, then at 6 and 12 weeks
Change on single leg calf-raise endurance test
Time frame: At baseline, then at 6 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 31725362Centner 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.
- Results publication: PubMed 26018970Beyer 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.
- Results publication: PubMed 30636702Murphy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo Intelangelo, MSc, PT contact
Gonzalo Elias, PT principal investigator
University of Gran Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Load Training with Blood Flow Restriction and High Load Training in people with Achilles Tendinopathy and Achilles Tendon Pain, run by University of Gran Rosario at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gonzalo Elias, PT (543416051190, gelias@ugr.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on pain intensity (time frame: At baseline, then at 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05241197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.