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Completed

NCT Number: NCT04121377

Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture

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.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy and Occupational Therapy, Aalborg University Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Resistance training

Other

Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.

Primary outcomes

  1. Acceptability

    Time frame: 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".

  2. Compliance

    Time frame: 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 outcomes

  1. Fear of re-rupture

    Time frame: 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".

  2. Achilles tendon total rupture score (ATRS)

    Time frame: 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.

  3. Physical Activity

    Time frame: 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)

  4. Achilles tendon resting angle (ATRA)

    Time frame: 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.

  5. Achilles tendon length

    Time frame: At 10 weeks and 3 months

    Ultrasound measure of achilles tendon length.,

  6. Achilles tendon cross-sectional area

    Time frame: At 10 weeks and 3 months

    Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site

  7. Delay in start of exercise

    Time frame: At 10 weeks

    Delay in starting the exercise program is measured in days drom start to end of week 9

  8. Adverse events

    Time frame: At 10 weeks and 3 months

    The number of serious and minor adverse events is registered using open questions and a pre-defined list.

  9. Muscle endurance

    Time frame: At 3 months

    Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2019
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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