Achilles Tendon RuptureNCT04121377
Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
A study testing Resistance training in people with Achilles Tendon Rupture, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon. 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?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Oct 2019to 30 Apr 2020
- 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 Achilles tendon rupture treated non-surgically
- Diagnosed and treatment initiated within 3 days of injury
- Age 18-65, able and willing to participate in the intervention
- Able to speak and understand Danish
Who cannot join
- Insertional Achilles tendon rupture on calcaneus or rupture 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 Fluoroquinolones or Corticosteroids within the last 6 months
- Diabetes
- Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Physiotherapy and Occupational Therapy, Aalborg University Hospital
Aalborg, 9000
About this study
The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.
Read the detailed description
Regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after Achilles tendon rupture is found up to 10 years later. The majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports.
There has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. In general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises.
The primary aim is to test the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise program | Experimental | Early resistance exercise sessions and home program Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
The participants will rate their acceptability (willingness) to perform the exercises on a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the patient's symptoms have improved to normal physical function or any other satisfactory level at the specific time, but if it matches, their expectations of the content of an exercise program in this early phase and how they tolerate performing the exercises. The intervention program is categorised as "Unacceptable" if rated as the three lower scores ("very unacceptable" to "slightly unacceptable") and categorised as "Acceptable" if rated as the four higher scores ("neither acceptable or unacceptable" to "very acceptable"). The exercise program is considered feasible if acceptability of the exercise program is 80%. Defined as: ≥13/16 patients will rate the acceptability of the intervention as "acceptable".
Measured: At 10 week follow-up
Compliance
The participants will register the number of training sessions and exercises they perform each day in a training journal. The compliance is measured as the mean number of exercise sessions they perform. The timeframe will be from the day they start the exercises to the end of week 9. The exercise program is considered feasible if the adherence to the exercise program is 50%. Defined as: ≥13/16 patients will perform ≥ 50% of the exercise sessions possible from start to end of week 9.
Measured: At 10 week follow-up
Secondary outcomes (9)
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". During the exercise intervention period and at 3 months follow,up the patients will fill out the score and subsequently they are asked to rate the appropriateness of the score on a 7 point Likert scale ranging from "strongly disagree" to "strongly agree".
Measured: At 2 and 10 weeks and at 3 months
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 for a pre-rupture level and at 3 months
Physical Activity
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 for a pre-rupture level and at 3 months
Achilles tendon resting angle (ATRA)
Indirect measure of the Achilles tendon length. It is measured in degrees between the axis of the fibula (from malleol to proximal head) and the line from the tip of the fibula to the head of the Fifth metatarsal bone.
Measured: At 10 weeks and at 3 months
Achilles tendon length
Ultrasound measure of achilles tendon length.,
Measured: At 10 weeks and 3 months
Achilles tendon cross-sectional area
Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site
Measured: At 10 weeks and 3 months
Delay in start of exercise
Delay in starting the exercise program is measured in days drom start to end of week 9
Measured: At 10 weeks
Adverse events
The number of serious and minor adverse events is registered using open questions and a pre-defined list.
Measured: At 10 weeks and 3 months
Muscle endurance
Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start11 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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, Physiotherapy and Occupational Therapy, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121377
- Sponsor's protocol ID
- N-20180072
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2019
- Last updated
- 14 Oct 2020
- 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
Publications
Christensen M, Silbernagel KG, Zellers JA, Kjaer IL, Rathleff MS. Feasibility of an early progressive resistance exercise program for acute Achilles tendon rupture. Pilot Feasibility Stud. 2024 Apr 22;10(1):66. doi: 10.1186/s40814-024-01494-4.
PubMed 38650039
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
- ClinicalTrials.gov ID
- NCT04121377
- Acronym / sponsor ID
- N-20180072
- Conditions
- Achilles Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 9 Oct 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.
The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.
Detailed description
Regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after Achilles tendon rupture is found up to 10 years later. The majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports.
There has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. In general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises.
The primary aim is to test the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise program | Experimental | Other: Resistance trainingEarly resistance exercise sessions and home program |
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 Achilles tendon rupture treated non-surgically
- Diagnosed and treatment initiated within 3 days of injury
- Age 18-65, able and willing to participate in the intervention
- Able to speak and understand Danish
Key exclusion criteria (5 listed)
- Insertional Achilles tendon rupture on calcaneus or rupture 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 Fluoroquinolones or Corticosteroids within the last 6 months
- Diabetes
- 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 |
|---|---|---|
| Resistance trainingWeekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected. | Other | Resistance exercise program |
Primary outcome
Acceptability
Time frame: At 10 week follow-up
The participants will rate their acceptability (willingness) to perform the exercises on a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the patient's symptoms have improved to normal physical function or any other satisfactory level at the specific time, but if it matches, their expectations of the content of an exercise program in this early phase and how they tolerate performing the exercises. The intervention program is categorised as "Unacceptable" if rated as the three lower scores ("very unacceptable" to "slightly unacceptable") and categorised as "Acceptable" if rated as the four higher scores ("neither acceptable or unacceptable" to "very acceptable"). The exercise program is considered feasible if acceptability of the exercise program is 80%. Defined as: ≥13/16 patients will rate the acceptability of the intervention as "acceptable".
Compliance
Time frame: At 10 week follow-up
The participants will register the number of training sessions and exercises they perform each day in a training journal. The compliance is measured as the mean number of exercise sessions they perform. The timeframe will be from the day they start the exercises to the end of week 9. The exercise program is considered feasible if the adherence to the exercise program is 50%. Defined as: ≥13/16 patients will perform ≥ 50% of the exercise sessions possible from start to end of week 9.
9 secondary outcomes
Fear of re-rupture
Time frame: At 2 and 10 weeks and at 3 months
Achilles tendon total rupture score (ATRS)
Time frame: Baseline for a pre-rupture level and at 3 months
Physical Activity
Time frame: Baseline for a pre-rupture level and at 3 months
Achilles tendon resting angle (ATRA)
Time frame: At 10 weeks and at 3 months
Achilles tendon length
Time frame: At 10 weeks and 3 months
Achilles tendon cross-sectional area
Time frame: At 10 weeks and 3 months
Delay in start of exercise
Time frame: At 10 weeks
Adverse events
Time frame: At 10 weeks and 3 months
Muscle endurance
Time frame: At 3 months
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 14 Oct 2020.
- Derived from this study: PubMed 38650039Christensen M, Silbernagel KG, Zellers JA, Kjaer IL, Rathleff MS. Feasibility of an early progressive resistance exercise program for acute Achilles tendon rupture. Pilot Feasibility Stud. 2024 Apr 22;10(1):66. doi: 10.1186/s40814-024-01494-4.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
Related trials for Achilles Tendon Rupture
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles 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
Physiotherapy and Occupational Therapy, Aalborg University 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 Resistance training in people with Achilles Tendon Rupture, run by Aalborg University 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 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 14 Oct 2020. 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?
Acceptability (time frame: At 10 week follow-up). 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 NCT04121377, which also lists 1 linked publication.
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 14 Oct 2020.