Achilles TendinopathyNCT04210999
Resistance Training and Injection Treatment for Chronic Achilles Tendinopathy
A study testing Homebased resistance training and Supervised heavy slow resistance training in people with Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals. The primary purpose of the study is to compare treatment with supervised or homebased resistance training. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Homebased resistance training and Supervised heavy slow resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Apr 2022to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain from the achilles tendon either unilateral or bilateral for at least 3 months
- Achilles tendinopathy in the tendon midtsubstance verified by ultrasound
- Between 18 and 65 years of age
- For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
- For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm
Who cannot join
- Prior surgery in the leg with the exception of knee artroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles tendinopati within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Supervised or Homebased Resistance Training the Best Treatment for Chronic Achilles Tendinopathy? And When Needed is Supplement Treatment With Either Corticosteroid or High Volume Injection the Best Choice
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training. The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
Read more
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
- Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy
- HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1
- Surgery improves symptoms in patients not responding to treatment 1 and treatment 2
Study 1: 90 patients between 18 and 65 years of age with achilles tendinopathy for at least 3 months are randomly assigned to either A. Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months B. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Outcomes are change in patient reported outcome (VISA-A) from baseline to 3 and 6 months, ultrasound measured thickness and dopler activity of the achilles tendon, self reported activity level in percentage of the pre injury activity level.
After the 3-month training intervention, and for the following 9 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the second part of the study.
Study 2: Patients from study 1 which not are satisfied with the outcome are randomly assigned to either
- Same training intervention continued + High Volume Injection (HVI) B. Same training intervention continued + corticosteroid injection
After the 4-month and for the following 8 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the third part of the study.
Study 3: Patients from study 2 which not are satisfied with the outcome are operated
Read the detailed description
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals. Treatment options typically include rest from high load weight bearing activities, resistance training, injections with corticosteroid (CS) or High Volume Injection (HVI) and surgery.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training.
The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
- Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy (RCT, non-inferiority design).
- HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1. (RCT, superiority design).
- Surgery improves symptoms in patients not responding to treatment 1. and treatment 2. (prospective cohort).
Study 1: 90 patients with achilles tendinopathy are randomly assigned to either
- Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months D. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Inclusion criteria
- Pain from the achilles tendon either unilateral or bilateral for at least 3 months
- Achilles tendinopathy in the tendon midsubstance verified by ultrasound
- Between 18 and 65 years of age
- For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
- For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm Exclusion criteria
- Prior surgery in the leg with the exception of knee arthroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles tendinopathy within the last 6 months
Patients are stratified based on the severity of symptoms (below or above 50 on VISA-A) and duration of symptoms (shorter or longer than 1 year)
- Conditions
- Achilles Tendinopathy
- Being tested
- Homebased resistance training, Supervised heavy slow resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homebased resistance trainingOther
Resistance training at home instructed via a smart phone training app
Supervised heavy slow resistance trainingOther
Heavy slow resistance training in the gym instructed by a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Homebased resistance training | Experimental | Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months Receives: Other: Homebased resistance training |
| Supervised resistance training | Active comparator | Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months Receives: Other: Supervised heavy slow resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Measured: After 3 and 6 months in study 1. After 6 months in study 2. After 6 and 12 months in study 3.
Secondary outcomes (5)
Evaluation of treatment effect measured on an 11-point Likert scale.
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is cured and -5 is much worsened, 0 is the status when entering the study.
Measured: After 1, 2, 3, 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
Measured: After 1, 2, 9 and 12 months in study 1. After 1, 3, 6, 9 and 12 months in study 2. After 3 months in study 3.
Evaluation of the training experience measured on a Likert scale.
The Likert scale used is an 11-point scale ranging from -5 to +5. +5 is very inspiring/motivating, -5 is very uninspiring/boring, 0 representing the status when entering the study.
Measured: After 3 months in study 1. After 3 months in study 2.
Ultrasonographic measurement of achilles tendon thickness and doppler activity.
Ultrasonographic measurement of achilles tendon thickness and doppler activity is measured relative to the baseline values.
Measured: After 0, 1, 2, 3, 6 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Patient self reported activity level in percentage of the pre-injury activity level.
Self reported activity level in percentage of the pre-injury activity level is reported.
Measured: After 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start5 Apr 2022
- Primary completion30 Oct 2026
- Study completion30 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Doessing, M.D., PhD, Bispebjerg Hospital
- Investigators
- Michael Kjaer, MD. PhD, Study director, University of Copenhagen and Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210999
- Sponsor's protocol ID
- H-19040270
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Supervised or Homebased Resistance Training the Best Treatment for Chronic Achilles Tendinopathy? And When Needed is Supplement Treatment With Either Corticosteroid or High Volume Injection the Best Choice
- ClinicalTrials.gov ID
- NCT04210999
- Acronym / sponsor ID
- H-19040270
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Oct 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 26 Dec 2019 (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.
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training. The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
- Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy
- HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1
- Surgery improves symptoms in patients not responding to treatment 1 and treatment 2
Study 1: 90 patients between 18 and 65 years of age with achilles tendinopathy for at least 3 months are randomly assigned to either A. Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months B. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Outcomes are change in patient reported outcome (VISA-A) from baseline to 3 and 6 months, ultrasound measured thickness and dopler activity of the achilles tendon, self reported activity level in percentage of the pre injury activity level.
After the 3-month training intervention, and for the following 9 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the second part of the study.
Study 2: Patients from study 1 which not are satisfied with the outcome are randomly assigned to either
- Same training intervention continued + High Volume Injection (HVI) B. Same training intervention continued + corticosteroid injection
After the 4-month and for the following 8 months, those patients that not are satisfied with the outcome will have the opportunity to participate in the third part of the study.
Study 3: Patients from study 2 which not are satisfied with the outcome are operated
Detailed description
Achilles tendinopathy is a common and often long-lasting injury among exercising individuals. Treatment options typically include rest from high load weight bearing activities, resistance training, injections with corticosteroid (CS) or High Volume Injection (HVI) and surgery.
The primary purpose of the study is to compare treatment with supervised or homebased resistance training.
The secondary purpose is to compare treatment with either corticosteroid or High Volume Injection (HVI) for those patients not responding to the primary treatment.
The tertiary purpose is to evaluate the effect of surgery in those patients not responding to the primary and the secondary treatment.
It is hypothesized that:
- Homebased resistance training is as effective as supervised resistance training for treating chronic achilles tendinopathy (RCT, non-inferiority design).
- HVI injection is better than CS injection for those patients not responding sufficiently to treatment 1. (RCT, superiority design).
- Surgery improves symptoms in patients not responding to treatment 1. and treatment 2. (prospective cohort).
Study 1: 90 patients with achilles tendinopathy are randomly assigned to either
- Resistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months D. Heavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months
Inclusion criteria
- Pain from the achilles tendon either unilateral or bilateral for at least 3 months
- Achilles tendinopathy in the tendon midsubstance verified by ultrasound
- Between 18 and 65 years of age
- For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
- For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm Exclusion criteria
- Prior surgery in the leg with the exception of knee arthroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles tendinopathy within the last 6 months
Patients are stratified based on the severity of symptoms (below or above 50 on VISA-A) and duration of symptoms (shorter or longer than 1 year)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Homebased resistance training | Experimental | Other: Homebased resistance trainingResistance training at home instructed via a smart phone training app and avoidance of pain aggravating activities for 3 months |
| Supervised resistance training | Active comparator | Other: Supervised heavy slow resistance trainingHeavy slow resistance training in the gym instructed by a physiotherapist and avoidance of pain aggravating activities for 3 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain from the achilles tendon either unilateral or bilateral for at least 3 months
- Achilles tendinopathy in the tendon midtsubstance verified by ultrasound
- Between 18 and 65 years of age
- For patients with unilaterale symptoms the symptomatic tendon must be at least 20% thicker than on the asymptomatic side or more than 7 mm thick
- For patients with bilateral symptoms the achilles tendons must have diameters above 7 mm
Key exclusion criteria (4 listed)
- Prior surgery in the leg with the exception of knee artroscopy
- Known medial conditions including diabetes or rheumatologic diseases
- Taking pain medication regularly
- Injection therapy for treatment of achilles tendinopati within the last 6 months
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 |
|---|---|---|
| Homebased resistance trainingResistance training at home instructed via a smart phone training app | Other | Homebased resistance training |
| Supervised heavy slow resistance trainingHeavy slow resistance training in the gym instructed by a physiotherapist | Other | Supervised resistance training |
Primary outcome
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
Time frame: After 3 and 6 months in study 1. After 6 months in study 2. After 6 and 12 months in study 3.
VISA-A is a patient reported outcome measure (PROM). Change from baseline is measured and reported. The scale ranges from 0-100 points. Higher score meaning a better outcome.
5 secondary outcomes
Evaluation of treatment effect measured on an 11-point Likert scale.
Time frame: After 1, 2, 3, 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A).
Time frame: After 1, 2, 9 and 12 months in study 1. After 1, 3, 6, 9 and 12 months in study 2. After 3 months in study 3.
Evaluation of the training experience measured on a Likert scale.
Time frame: After 3 months in study 1. After 3 months in study 2.
Ultrasonographic measurement of achilles tendon thickness and doppler activity.
Time frame: After 0, 1, 2, 3, 6 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Patient self reported activity level in percentage of the pre-injury activity level.
Time frame: After 6, 9 and 12 months in study 1 and study 2. After 3, 6 and 12 months in study 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Related trials for Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
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. This study is not recruiting at the moment.
Michael Kjaer, MD. PhD study director
University of Copenhagen and Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homebased resistance training and Supervised heavy slow resistance training in people with Achilles Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 2 Nov 2026. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in The Victorian Institute of Sports Assessment - Achilles Questionnaire (VISA-A). (time frame: After 3 and 6 months in study 1. After 6 months in study 2. After 6 and 12 months in study 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.