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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care exercises | Active Comparator | This is the currently used treatment in the nine weeks of immobilisation with an orthosis. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard exercises | Other | Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness outcomes | Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire | 9, 13, 26 and 52 weeks |
| Self-reported health state |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Christensen, MHSc | Aalborg University Hospital | Principal Investigator |
| Inge Lunding Kjær, MD | Aalborg University Hospital | Study Chair |
| Jennifer A Zellers, PhD | Washington University School of Medicine in St. Louis, USA | Study Chair |
| Karin Grävare Silbernagel, PhD | University of Delaware, DE USA | Study Chair |
| Michael Skovdal Rathleff, PhD | Aalborg University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
Data will be available upon reasonable request
After completion of the 1 year follow-up
Researchers that provide a methodologically sound plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 23, 2021 | Jan 23, 2021 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2023 | Jun 7, 2023 | SAP_001.pdf |
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| Standard exercises plus Early progressive exercises | Other | 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. |
|
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 |
EQ-5D-5L is a generic health-related quality of life instrument
| Baseline, 9, 13, 26, 52 weeks |
| Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring |
| Hjørring |
| 9800 |
| Denmark |