Clinical trial NCT01298024: A Pilot Study on Exercise After Achilles Tendon Rupture
Official title: NEMEX-ATR: A Randomized Pilot Study on Early Neuromuscular Exercise in Non-surgically Treated Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Achilles Tendon Rupture
Keywords: Achilles tendon rupture
Non-surgical treatment
Exercise
Neuromuscular training
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2011-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Heel-raise
timeFrame: Week 16
Secondary outcomes:
measure: Single limb standing balance
timeFrame: At weeks 4, 8 and 16
measure: 30-meters walk test
timeFrame: At weeks 8 and 16
measure: Single-limb mini squat
timeFrame: At week 16
measure: VAS Pain
timeFrame: At weeks 1, 4, 8 and 16
measure: Range of Motion
timeFrame: At weeks 1, 4, 8 and 16
measure: The calf muscle circumference
timeFrame: At weeks 1, 4, 8 and 16
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: At weeks 1, 4, 8 and 16
measure: Short-Form 36 (SF-36)
timeFrame: At weeks 1, 4, 8 and 16
measure: Physical Activity Level Scale
timeFrame: At weeks 1, 4, 8 and 16
measure: Re-rupture
timeFrame: Weeks 1-16
measure: Deep Venous thromboembolism
timeFrame: Weeks 1-16
measure: Sick leave
timeFrame: Measured regularly from baseline until week 16
measure: Modified Forward lunge from stairs
timeFrame: week 16
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Lund University
name: Eva Ageberg, PT, PhD
role: STUDY_DIRECTOR
affiliation: Skane University Hospital
name: Sylvia Resch, MD, PhD
role: STUDY_DIRECTOR
References: