A Pilot Study on Exercise After Achilles Tendon Rupture (NEMEX-ATR)

NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture

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).

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Early Neuromuscular Exercise

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 222 37
      • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early neuromusclar exercise	Other: 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.; Other Names: Treatment as usual (late exercise)
Active Comparator: Treatment as usual (late training)	Other: 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.; Other Names: Treatment as usual (late exercise)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heel-raise	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.	Week 16

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Study Director: Eva Ageberg, PT, PhD, Lund University; Study Director: Sylvia Resch, MD, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Achilles tendon rupture; Neuromuscular training; Non-surgical treatment
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2010/173