Achilles Tendon Rupture
Conditions
Keywords
Achilles tendon rupture, Early functional rehabilitation, Resistance training
Brief 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
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.
Interventions
OTHERStandard exercises
Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.
OTHERStandard exercises plus Early progressive exercises
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.
Sponsors
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achilles tendon total rupture score ATRS | 13 weeks | Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achilles tendon total rupture score ATRS | Baseline, 26 and 52 weeks | Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten. |
| International Physical Activity Questionnaire (IPAQ) | baseline, 13, 26 and 52 weeks | 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) |
| Achilles tendon resting angle (ATRA) | 13 and 52 weeks | ATRA is validated as an indirect measure of the Achilles tendon length |
| Achilles tendon length | 9, 13 and 52 weeks | Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM) |
| Isometric muscle strength | 9, 13 and 52 weeks | maximal isometric plantar flexor muscle strength using a Fysiometer |
| Adverse events | 9, 13 and 52 weeks | The number of serious and minor adverse events is registered in a pre-defined list based on Common Terminology Criteria for Adverse Events |
| Compliance | 9 weeks | The participants will register the number of exercise sessions they perform each day in a training journal. |
| Muscle endurance | 13 and 52 weeks | Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway) |
| The fear of re-rupture | 9, 13 and 52 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness outcomes | 9, 13, 26 and 52 weeks | Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire |
| Self-reported health state | Baseline, 9, 13, 26, 52 weeks | EQ-5D-5L is a generic health-related quality of life instrument |
Countries
Denmark
Outcome results
None listed