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

This study has been completed.
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01298024
First received: February 9, 2011
Last updated: April 5, 2013
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Achilles Tendon Rupture
Other: Early Neuromuscular Exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Heel-raise [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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:
  • Single limb standing balance [ Time Frame: At weeks 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients stands on one leg with eyes open as long as possible, maximum time 60 seconds. Both legs are tested.

  • 30-meters walk test [ Time Frame: At weeks 8 and 16 ] [ Designated as safety issue: No ]
    The patients walks a distance of 30 m at self-selected speed. Time and any limbing is recorded.

  • Single-limb mini squat [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    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.

  • VAS Pain [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The patients reports pain on a 0-10 visual analog scale.

  • Range of Motion [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    The range of plantar and dorsal flexion motions in the talocrural joint are measured with a handheld goniometer.

  • The calf muscle circumference [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    Calf muscle circumference is recording using a measuring-tape.

  • Foot and Ankle Outcome Score (FAOS) [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A disease specific questionnaire for patients with foot and ankle injury.

  • Short-Form 36 (SF-36) [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A generic measure of health status.

  • Physical Activity Level Scale [ Time Frame: At weeks 1, 4, 8 and 16 ] [ Designated as safety issue: No ]
    A scale that measures the patient's level of daily physical activity.

  • Re-rupture [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.

  • Deep Venous thromboembolism [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: Yes ]
    Joint specific adverse event; recorded by any patient seeking medical care related to the achilles tendon rupture during the study period.

  • Sick leave [ Time Frame: Measured regularly from baseline until week 16 ] [ Designated as safety issue: No ]
    The number of weeks the patient are not at work caused of the achilles tendon rupture is registered.

  • Modified Forward lunge from stairs [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Treatment as usual (late 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298024

Locations
Sweden
Skåne University Hospital
Lund, Skåne, Sweden, 222 37
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Study Director: Eva Ageberg, PT, PhD Lund University
Study Director: Sylvia Resch, MD, PhD Skane University Hospital
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01298024     History of Changes
Other Study ID Numbers: 2010/173
Study First Received: February 9, 2011
Last Updated: April 5, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Achilles tendon rupture
Non-surgical treatment
Exercise
Neuromuscular training

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014