A Pilot Study on Exercise After Achilles Tendon Rupture

Phase 2

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Other: Early Neuromuscular Exercise

• Registration Number: NCT01298024
• Lead Sponsor: Region Skane

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Study Start: 2011-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early neuromusclar exercise	Early Neuromuscular Exercise	-
Treatment as usual (late training)	Early Neuromuscular Exercise	-

Primary Outcome Measures

Name	Time	Method
Heel-raise	Week 16	Functional performance of calf muscles. The ability to perform a plantar flexion is assessed in a prone position at 1 and 4 weeks after the injury. At 8 and 16 weeks after the injury, the ability to perform a heel-raise standing on one leg is assessed.

Secondary Outcome Measures

Name	Time	Method
VAS Pain	At weeks 1, 4, 8 and 16	The patients reports pain on a 0-10 visual analog scale.
Range of Motion	At weeks 1, 4, 8 and 16	The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.
30-meters walk test	At weeks 8 and 16	The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.
Deep Venous thromboembolism	Weeks 1-16	Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Single limb standing balance	At weeks 4, 8 and 16	The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.
Single-limb mini squat	At week 16	The patients performs single-limb mini squats. The position of the knee in relation to the foot is assessed. The test is performed on both legs.
The calf muscle circumference	At weeks 1, 4, 8 and 16	Calf muscle circumference is recording using a measuring-tape.
Foot and Ankle Outcome Score (FAOS)	At weeks 1, 4, 8 and 16	A disease specific questionnaire for patients with foot and ankle injury.
Short-Form 36 (SF-36)	At weeks 1, 4, 8 and 16	A generic measure of health status.
Re-rupture	Weeks 1-16	Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.
Modified Forward lunge from stairs	week 16	The patient stands on the first step of a staircase and is encouraged to take step down with one leg, the other leg kept on the step. The examiner stands in front of the patient and observes position of joints in relation to each other.
Physical Activity Level Scale	At weeks 1, 4, 8 and 16	A scale that measures the patient's level of daily physical activity.
Sick leave	Measured regularly from baseline until week 16	The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Lund, Skåne, Sweden