Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Other: Standard exercises
* Other: Standard exercises plus Early progressive exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care exercises<br>This is the currently used treatment in the nine weeks of immobilisation with an orthosis. | Other: Standard exercises<br>* Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.<br>|
| Experimental: Early progressive strength exercise<br>This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. | Other: Standard exercises plus Early progressive exercises<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | baseline, 13, 26 and 52 weeks | 
| Achilles tendon resting angle (ATRA) | ATRA is validated as an indirect measure of the Achilles tendon length | 13 and 52 weeks | 
| Achilles tendon length | Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM) | 9, 13 and 52 weeks | 
| Isometric muscle strength | maximal isometric plantar flexor muscle strength using a Fysiometer | 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) | 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. | 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 | 9, 13 and 52 weeks | 
| Compliance | The participants will register the number of exercise sessions they perform each day in a training journal. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles tendon rupture, Early functional rehabilitation, Resistance training