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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2023-11-23

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

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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.

Conditions

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Achilles Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard care exercises

This is the currently used treatment in the nine weeks of immobilisation with an orthosis.

Group Type ACTIVE_COMPARATOR

Standard exercises

Intervention Type 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.

Early progressive strength exercise

This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration.

Group Type EXPERIMENTAL

Standard exercises plus Early progressive exercises

Intervention Type 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.

Interventions

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Standard 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.

Intervention Type OTHER

Standard 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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No