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Clinical Trials/NCT04726189
NCT04726189
Completed
N/A

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.

Aalborg University Hospital2 sites in 1 country82 target enrollmentMarch 19, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Achilles Tendon Rupture
Sponsor
Aalborg University Hospital
Enrollment
82
Locations
2
Primary Endpoint
Achilles tendon total rupture score ATRS
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2021
End Date
November 23, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marianne Christensen

PT, PHD student

Aalborg University Hospital

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
  • (ASA: American Society of Anesthesiologists physical status classification system)

Outcomes

Primary Outcomes

Achilles tendon total rupture score ATRS

Time Frame: 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 Outcomes

  • The fear of re-rupture(9, 13 and 52 weeks)
  • Compliance(9 weeks)
  • Achilles tendon resting angle (ATRA)(13 and 52 weeks)
  • Adverse events(9, 13 and 52 weeks)
  • International Physical Activity Questionnaire (IPAQ)(baseline, 13, 26 and 52 weeks)
  • Achilles tendon length(9, 13 and 52 weeks)
  • Isometric muscle strength(9, 13 and 52 weeks)
  • Muscle endurance(13 and 52 weeks)
  • Achilles tendon total rupture score ATRS(Baseline, 26 and 52 weeks)

Study Sites (2)

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