Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Severe medical illness: ASA score higher than or equal to
- •(ASA: American Society of Anesthesiologists physical status classification system)
结局指标
主要结局
Acceptability
时间窗: 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
时间窗: 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.
次要结局
- Fear of re-rupture(At 2 and 10 weeks and at 3 months)
- Achilles tendon total rupture score (ATRS)(Baseline for a pre-rupture level and at 3 months)
- Physical Activity(Baseline for a pre-rupture level and at 3 months)
- Achilles tendon resting angle (ATRA)(At 10 weeks and at 3 months)
- Adverse events(At 10 weeks and 3 months)
- Muscle endurance(At 3 months)
- Achilles tendon length(At 10 weeks and 3 months)
- Achilles tendon cross-sectional area(At 10 weeks and 3 months)
- Delay in start of exercise(At 10 weeks)
研究者
Marianne Christensen
PT, PHD student
Aalborg University Hospital