Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
- Conditions
- Achilles Tendon Rupture
- Interventions
- Other: Resistance training
- Registration Number
- NCT04121377
- Lead Sponsor
- Aalborg University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Resistance exercise program Resistance training Early resistance exercise sessions and home program
- Primary Outcome Measures
Name Time Method Acceptability At 10 week follow-up The participants will rate their acceptability (willingness) to perform the exercises on a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the patient's symptoms have improved to normal physical function or any other satisfactory level at the specific time, but if it matches, their expectations of the content of an exercise program in this early phase and how they tolerate performing the exercises. The intervention program is categorised as "Unacceptable" if rated as the three lower scores ("very unacceptable" to "slightly unacceptable") and categorised as "Acceptable" if rated as the four higher scores ("neither acceptable or unacceptable" to "very acceptable"). The exercise program is considered feasible if acceptability of the exercise program is 80%. Defined as: ≥13/16 patients will rate the acceptability of the intervention as "acceptable".
Compliance At 10 week follow-up The participants will register the number of training sessions and exercises they perform each day in a training journal. The compliance is measured as the mean number of exercise sessions they perform. The timeframe will be from the day they start the exercises to the end of week 9. The exercise program is considered feasible if the adherence to the exercise program is 50%. Defined as: ≥13/16 patients will perform ≥ 50% of the exercise sessions possible from start to end of week 9.
- Secondary Outcome Measures
Name Time Method Fear of re-rupture At 2 and 10 weeks and at 3 months The Tampa scale of Kinesiophobia (TSK) is a questionaire consisting of 17 items concerning pain and kinesiophobia and has 4 answers from "Strongly disagree" to "Strongly agree". During the exercise intervention period and at 3 months follow,up the patients will fill out the score and subsequently they are asked to rate the appropriateness of the score on a 7 point Likert scale ranging from "strongly disagree" to "strongly agree".
Achilles tendon total rupture score (ATRS) Baseline for a pre-rupture level and at 3 months Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
Physical Activity Baseline for a pre-rupture level and at 3 months International Physical Activity Questionnaire (IPAQ) short form Danish version. It consists of 7 items concerning physical activity as time spent performing vigorous and moderate activities, the time spent walking and sitting during the past week. The IPAQ gives an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting.(MET: The Metabolic Equivalent of Task)
Achilles tendon resting angle (ATRA) At 10 weeks and at 3 months Indirect measure of the Achilles tendon length. It is measured in degrees between the axis of the fibula (from malleol to proximal head) and the line from the tip of the fibula to the head of the Fifth metatarsal bone.
Adverse events At 10 weeks and 3 months The number of serious and minor adverse events is registered using open questions and a pre-defined list.
Muscle endurance At 3 months Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Achilles tendon length At 10 weeks and 3 months Ultrasound measure of achilles tendon length.,
Achilles tendon cross-sectional area At 10 weeks and 3 months Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site
Delay in start of exercise At 10 weeks Delay in starting the exercise program is measured in days drom start to end of week 9
Trial Locations
- Locations (1)
Physiotherapy and Occupational Therapy, Aalborg University Hospital
🇩🇰Aalborg, Denmark