Clinical trial NCT04121377: Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Official title: Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.

Detailed description: Regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after Achilles tendon rupture is found up to 10 years later. The majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports.

There has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. In general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises.

The primary aim is to test the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.

Eligibility criteria: Inclusion Criteria:

* Acute Achilles tendon rupture treated non-surgically
* Diagnosed and treatment initiated within 3 days of injury
* Age 18-65, able and willing to participate in the intervention
* Able to speak and understand Danish

Exclusion Criteria:

* Insertional Achilles tendon rupture on calcaneus or rupture in the musculo-tendinous junction of the triceps surae
* Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
* Treated with Fluoroquinolones or Corticosteroids within the last 6 months
* Diabetes
* Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)

Primary outcomes:
measure: Acceptability
timeFrame: At 10 week follow-up
measure: Compliance
timeFrame: At 10 week follow-up
Secondary outcomes:
measure: Fear of re-rupture
timeFrame: At 2 and 10 weeks and at 3 months
measure: Achilles tendon total rupture score (ATRS)
timeFrame: Baseline for a pre-rupture level and at 3 months
measure: Physical Activity
timeFrame: Baseline for a pre-rupture level and at 3 months
measure: Achilles tendon resting angle (ATRA)
timeFrame: At 10 weeks and at 3 months
measure: Achilles tendon length
timeFrame: At 10 weeks and 3 months
measure: Achilles tendon cross-sectional area
timeFrame: At 10 weeks and 3 months
measure: Delay in start of exercise
timeFrame: At 10 weeks
measure: Adverse events
timeFrame: At 10 weeks and 3 months
measure: Muscle endurance
timeFrame: At 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Physiotherapy and Occupational Therapy, Aalborg University Hospital
Study officials:
affiliation: Physiotherapy and Occupational Therapy, Aalborg University Hospital
name: Marianne Christensen, MHSc
role: PRINCIPAL_INVESTIGATOR
References: