Achilles Tendon RuptureNCT04726189
Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.
A study testing Standard exercises and Standard exercises plus Early progressive exercises in people with Achilles Tendon Rupture, run by Aalborg University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Standard exercises and Standard exercises plus Early progressive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesDenmark
- Study dates
- 19 Mar 2021to 23 Nov 2023
- 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
- Acute total Achilles tendon rupture treated non-surgically
- Diagnosed within 3 days (of their injury)
- Age 18 - 65, able and willing to participate in the intervention
- Able to speak and understand Danish
Who cannot join
- Achilles tendon rupture close to insertion on calcaneus or in the musculo-tendinous junction of the triceps surae
- Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
- Treated with Fluoroquinolons or Corticosteroids within the last 6 months
- Diabetes or rheumatic diseases
- Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital
Aalborg, 9000
Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring
Hjørring, 9800
About this study
Official title: A Randomized Controlled Trial on the Effect of Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture. The Achilles Tendon Back-On-Track Study.
The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture
Read the detailed description
Acute Achilles tendon rupture often results in long-term muscular deficits. Patients struggle to return to work and sports with high load on the lower leg. Early functional rehabilitation has shown good results, but research on resistance exercise is scarce and the reporting of the specifics of the exercises are poor.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Standard exercises, Standard exercises plus Early progressive exercises
- Keywords
- Achilles tendon rupture, Early functional rehabilitation, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard exercisesOther
Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.
Standard exercises plus Early progressive exercisesOther
This exercise program consists of standard exercises plus the early progressive program that initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. Exercises are isometric exercises from the second week and then gradually progression of load in seated heel-rise and resistance band exercises.
| Study group | Role | What they receive |
|---|---|---|
| Standard care exercises | Active comparator | This is the currently used treatment in the nine weeks of immobilisation with an orthosis. Receives: Other: Standard exercises |
| Early progressive strength exercise | Experimental | This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. Receives: Other: Standard exercises plus Early progressive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles tendon total rupture score ATRS
Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
Measured: 13 weeks
Secondary outcomes (9)
Achilles tendon total rupture score ATRS
Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
Measured: Baseline, 26 and 52 weeks
International Physical Activity Questionnaire (IPAQ)
International Physical Activity Questionnaire (IPAQ) short form Danish version. It consists of 7 items concerning physical activity as time spent performing vigorous and moderate activities, the time spent walking and sitting during the past week. The IPAQ gives an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting.(MET: The Metabolic Equivalent of Task)
Measured: baseline, 13, 26 and 52 weeks
Achilles tendon resting angle (ATRA)
ATRA is validated as an indirect measure of the Achilles tendon length
Measured: 13 and 52 weeks
Achilles tendon length
Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)
Measured: 9, 13 and 52 weeks
Isometric muscle strength
maximal isometric plantar flexor muscle strength using a Fysiometer
Measured: 9, 13 and 52 weeks
Muscle endurance
Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Measured: 13 and 52 weeks
The fear of re-rupture
The Tampa scale of Kinesiophobia (TSK) is a questionaire consisting of 17 items concerning pain and kinesiophobia and has 4 answers from "Strongly disagree" to "Strongly agree".
Measured: 9, 13 and 52 weeks
Adverse events
The number of serious and minor adverse events is registered in a pre-defined list based on Common Terminology Criteria for Adverse Events
Measured: 9, 13 and 52 weeks
Compliance
The participants will register the number of exercise sessions they perform each day in a training journal.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start19 Mar 2021
- Primary completion30 Jan 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Christensen, Aalborg University Hospital
- Investigators
- Marianne Christensen, MHSc, Principal investigator, Aalborg University HospitalInge Lunding Kjær, MD, Study chair, Aalborg University HospitalJennifer A Zellers, PhD, Study chair, Washington University School of Medicine in St. Louis, USAKarin Grävare Silbernagel, PhD, Study chair, University of Delaware, DE USAMichael Skovdal Rathleff, PhD, Study chair, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726189
- Sponsor's protocol ID
- N-20200041
- Status last verified
- Jun 2024
- First submitted
- 23 Jan 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Effect of Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture. The Achilles Tendon Back-On-Track Study.
- ClinicalTrials.gov ID
- NCT04726189
- Acronym / sponsor ID
- N-20200041
- Conditions
- Achilles Tendon Rupture
- Keywords
- Achilles tendon rupture, Early functional rehabilitation, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 27 Jan 2021 (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.
The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture
Detailed description
Acute Achilles tendon rupture often results in long-term muscular deficits. Patients struggle to return to work and sports with high load on the lower leg. Early functional rehabilitation has shown good results, but research on resistance exercise is scarce and the reporting of the specifics of the exercises are poor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care exercises | Active comparator | Other: Standard exercisesThis is the currently used treatment in the nine weeks of immobilisation with an orthosis. |
| Early progressive strength exercise | Experimental | Other: Standard exercises plus Early progressive exercisesThis exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute total Achilles tendon rupture treated non-surgically
- Diagnosed within 3 days (of their injury)
- Age 18 - 65, able and willing to participate in the intervention
- Able to speak and understand Danish
Key exclusion criteria (5 listed)
- Achilles tendon rupture close to insertion on calcaneus or in the musculo-tendinous junction of the triceps surae
- Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
- Treated with Fluoroquinolons or Corticosteroids within the last 6 months
- Diabetes or rheumatic diseases
- Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)
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 |
|---|---|---|
| Standard exercisesConsists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week. | Other | Standard care exercises |
| Standard exercises plus Early progressive exercisesThis exercise program consists of standard exercises plus the early progressive program that initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. Exercises are isometric exercises from the second week and then gradually progression of load in seated heel-rise and resistance band exercises. | Other | Early progressive strength exercise |
Primary outcome
Achilles tendon total rupture score ATRS
Time frame: 13 weeks
Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
9 secondary outcomes
Achilles tendon total rupture score ATRS
Time frame: Baseline, 26 and 52 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline, 13, 26 and 52 weeks
Achilles tendon resting angle (ATRA)
Time frame: 13 and 52 weeks
Achilles tendon length
Time frame: 9, 13 and 52 weeks
Isometric muscle strength
Time frame: 9, 13 and 52 weeks
Muscle endurance
Time frame: 13 and 52 weeks
The fear of re-rupture
Time frame: 9, 13 and 52 weeks
Adverse events
Time frame: 9, 13 and 52 weeks
Compliance
Time frame: 9 weeks
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 24 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
Related trials for Achilles Tendon Rupture
Not yet recruiting
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
Recruiting
Effect of BFR Rehab After Achilles Tendon Rupture
Achilles Tendon Rupture
Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Tendon Tear, Tendinopathy
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.
Marianne Christensen, MHSc principal investigator
Aalborg University Hospital
Inge Lunding Kjær, MD study chair
Aalborg University Hospital
Jennifer A Zellers, PhD study chair
Washington University School of Medicine in St. Louis, USA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard exercises and Standard exercises plus Early progressive exercises in people with Achilles Tendon Rupture, run by Aalborg University Hospital at 2 sites 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 5 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Achilles tendon total rupture score ATRS (time frame: 13 weeks). 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 24 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.