A Pilot Study on Exercise After Achilles Tendon Rupture

NCT ID: NCT01298024

Last Updated: 2022-12-23

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

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus conventional treatment (late exercise) in patients with acute non-operative achilles tendon rupture (ATR).

Detailed Description

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There is currently no consensus on treatment for achilles tendon rupture with regard to surgical or non-surgical treatment. In addition, the optimal time to start exercise treatment after the injury, with or without surgery, is not well understood. Animal studies show positive effects of early mobilization in tendon healing. Neuromuscular exercise has shown better effects than strength exercise in people with knee injury or knee disease. There are few studies in humans focusing on exercise as treatment, without surgical intervention, after ATR.

Conditions

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Achilles Tendon Rupture

Keywords

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Achilles tendon rupture Non-surgical treatment Exercise Neuromuscular training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early neuromusclar exercise

Group Type EXPERIMENTAL

Early Neuromuscular Exercise

Intervention Type OTHER

30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.

Treatment as usual (late training)

Group Type ACTIVE_COMPARATOR

Early Neuromuscular Exercise

Intervention Type OTHER

30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.

Interventions

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Early Neuromuscular Exercise

30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.

Intervention Type OTHER

Other Intervention Names

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Treatment as usual (late exercise)

Eligibility Criteria

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Inclusion Criteria

1. Men and women 18 - 60 years.
2. The patient should before the achilles tendon rupture have been able to walk independently without aid, walk without limping, run/jog and be able to jump on one leg
3. The patient shall be able to read, understand and to assimilate the written information about the study.

Exclusion Criteria

1. Previous achilles tendon rupture
2. Acute achilles tendon rupture, more than 5 days.
3. Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Ageberg, PT, PhD

Role: STUDY_DIRECTOR

Lund University

Sylvia Resch, MD, PhD

Role: STUDY_DIRECTOR

Skane University Hospital

Locations

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Skåne University Hospital

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2010/173

Identifier Type: -

Identifier Source: org_study_id