Clinical trial NCT04726189: Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture
Early functional rehabilitation
Resistance training
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Achilles tendon total rupture score ATRS
timeFrame: 13 weeks
Secondary outcomes:
measure: Achilles tendon total rupture score ATRS
timeFrame: Baseline, 26 and 52 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: baseline, 13, 26 and 52 weeks
measure: Achilles tendon resting angle (ATRA)
timeFrame: 13 and 52 weeks
measure: Achilles tendon length
timeFrame: 9, 13 and 52 weeks
measure: Isometric muscle strength
timeFrame: 9, 13 and 52 weeks
measure: Muscle endurance
timeFrame: 13 and 52 weeks
measure: The fear of re-rupture
timeFrame: 9, 13 and 52 weeks
measure: Adverse events
timeFrame: 9, 13 and 52 weeks
measure: Compliance
timeFrame: 9 weeks
Other outcomes:
measure: Cost-effectiveness outcomes
timeFrame: 9, 13, 26 and 52 weeks
measure: Self-reported health state
timeFrame: Baseline, 9, 13, 26, 52 weeks
Locations:
city: Aalborg
country: Denmark
facility: Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital
city: Hjørring
country: Denmark
facility: Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Marianne Christensen, MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital, Denmark
name: Inge Lunding Kjær, MD
role: STUDY_CHAIR
affiliation: Washington University School of Medicine in St. Louis, USA
name: Jennifer A Zellers, PhD
role: STUDY_CHAIR
affiliation: University of Delaware, DE USA
name: Karin Grävare Silbernagel, PhD
role: STUDY_CHAIR
affiliation: Aalborg University Hospital, Denmark
name: Michael Skovdal Rathleff, PhD
role: STUDY_CHAIR
References: