Achilles TendinopathyNCT00952042
Resistance Training as Treatment of Achilles Tendinopathy
A study testing Heavy slow resistance training and Eccentric resistance training in people with Achilles Tendinopathy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The use of eccentric resistance training as management of Achilles tendinopathy is widespread. The investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Heavy slow resistance training and Eccentric resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Oct 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral Achilles tendon pain,
- Symptoms for at least three months,
- Ultrasonographical tendon abnormalities, AND
- Able to comply with both intervention arms.
Who cannot join
- Bilateral symptoms,
- Previous surgery below knee,
- Corticosteroid injections below the knee during past year,
- Hypercholesterol,
- Diabetes, OR
- Arthritis.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen. Bispebjerg Hospital
Copenhagen NV, 2400
About this study
Official title: Heavy Slow Resistance Versus Eccentric Training in the Treatment of Achilles Tendinopathy. A Randomized Controlled Trial.
The use of eccentric resistance training as management of Achilles tendinopathy is widespread. The investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy.
Hypothesis: heavy slow resistance training is more effective than eccentric resistance training in the clinical management of Achilles tendinopathy.
- Conditions
- Achilles Tendinopathy
- Being tested
- Heavy slow resistance training, Eccentric resistance training
- Keywords
- Tendinopathy, Achilles, Eccentric training, Heavy slow resistance training
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy slow resistance trainingOther
Heel-raises. 12-6RM. each contraction performed slowly. three times weekly for 12 weeks
Eccentric resistance trainingOther
Eccentric heel-raises. 3 x 15 reps performed twice daily for 12 wks.
| Study group | Role | What they receive |
|---|---|---|
| Heavy slow resistance training | Experimental | 12 wks of heavy slow resistance training. training three times per week. each session: 3 heel-raise exercises. 12-6RM. Slow contractions. Receives: Other: Heavy slow resistance training |
| Eccentric resistance training | Active comparator | 12 wks of eccentric resistance training. 3 x 15 Eccentric heel-raises performed twice daily. Receives: Other: Eccentric resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISA-A score
Measured: 0,12 wks + 1yr follow-up
Secondary outcomes (1)
Tendon thickness
Measured: 0,12 wks + 1yr follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2012
- Study completionOct 2012
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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Beyer, University of Copenhagen
- Investigators
- Rikke Beyer, PhD. stud, Principal investigator, Institute of Sports Medicine Copenhagen (www.ismc.dk)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952042
- Sponsor's protocol ID
- Kongsgaard2
- Status last verified
- Jul 2014
- First submitted
- 3 Aug 2009
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Slow Resistance Versus Eccentric Training in the Treatment of Achilles Tendinopathy. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00952042
- Acronym / sponsor ID
- Kongsgaard2
- Conditions
- Achilles Tendinopathy
- Keywords
- Tendinopathy, Achilles, Eccentric training, Heavy slow resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Aug 2009 (estimated)
- 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.
The use of eccentric resistance training as management of Achilles tendinopathy is widespread. The investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy.
Hypothesis: heavy slow resistance training is more effective than eccentric resistance training in the clinical management of Achilles tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy slow resistance training | Experimental | Other: Heavy slow resistance training12 wks of heavy slow resistance training. training three times per week. each session: 3 heel-raise exercises. 12-6RM. Slow contractions. |
| Eccentric resistance training | Active comparator | Other: Eccentric resistance training12 wks of eccentric resistance training. 3 x 15 Eccentric heel-raises performed twice daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral Achilles tendon pain,
- Symptoms for at least three months,
- Ultrasonographical tendon abnormalities, AND
- Able to comply with both intervention arms.
Key exclusion criteria (6 listed)
- Bilateral symptoms,
- Previous surgery below knee,
- Corticosteroid injections below the knee during past year,
- Hypercholesterol,
- Diabetes, OR
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 |
|---|---|---|
| Heavy slow resistance trainingHeel-raises. 12-6RM. each contraction performed slowly. three times weekly for 12 weeks | Other | Heavy slow resistance training |
| Eccentric resistance trainingEccentric heel-raises. 3 x 15 reps performed twice daily for 12 wks. | Other | Eccentric resistance training |
Primary outcome
VISA-A score
Time frame: 0,12 wks + 1yr follow-up
1 secondary outcome
Tendon thickness
Time frame: 0,12 wks + 1yr follow-up
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 21 Jul 2014.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Rikke Beyer, PhD. stud principal investigator
Institute of Sports Medicine Copenhagen (www.ismc.dk)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy slow resistance training and Eccentric resistance training in people with Achilles Tendinopathy, run by University of Copenhagen 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 4 inclusion and 6 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 21 Jul 2014. 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?
VISA-A score (time frame: 0,12 wks + 1yr follow-up). 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 21 Jul 2014.