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Completed

NCT Number: NCT04726189

Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.

The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture

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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

Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark

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About this study

Acute Achilles tendon rupture often results in long-term muscular deficits. Patients struggle to return to work and sports with high load on the lower leg. Early functional rehabilitation has shown good results, but research on resistance exercise is scarce and the reporting of the specifics of the exercises are poor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute total Achilles tendon rupture treated non-surgically
  • Diagnosed within 3 days (of their injury)
  • Age 18 - 65, able and willing to participate in the intervention
  • Able to speak and understand Danish

Exclusion criteria

  • Achilles tendon rupture close to insertion on calcaneus or 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 Fluoroquinolons or Corticosteroids within the last 6 months
  • Diabetes or rheumatic diseases
  • Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)

Treatment and study plan

Standard Exercises

Other

Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.

Standard exercises plus Early progressive exercises

Other

This exercise program consists of standard exercises plus the early progressive program that initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. Exercises are isometric exercises from the second week and then gradually progression of load in seated heel-rise and resistance band exercises.

Primary outcomes

  1. Achilles tendon total rupture score ATRS

    Time frame: 13 weeks

    Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.

Secondary outcomes

  1. Achilles tendon total rupture score ATRS

    Time frame: Baseline, 26 and 52 weeks

    Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.

  2. International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline, 13, 26 and 52 weeks

    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)

  3. Achilles tendon resting angle (ATRA)

    Time frame: 13 and 52 weeks

    ATRA is validated as an indirect measure of the Achilles tendon length

  4. Achilles tendon length

    Time frame: 9, 13 and 52 weeks

    Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)

  5. Isometric muscle strength

    Time frame: 9, 13 and 52 weeks

    maximal isometric plantar flexor muscle strength using a Fysiometer

  6. Muscle endurance

    Time frame: 13 and 52 weeks

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

  7. The fear of re-rupture

    Time frame: 9, 13 and 52 weeks

    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".

  8. Adverse events

    Time frame: 9, 13 and 52 weeks

    The number of serious and minor adverse events is registered in a pre-defined list based on Common Terminology Criteria for Adverse Events

  9. Compliance

    Time frame: 9 weeks

    The participants will register the number of exercise sessions they perform each day in a training journal.

Other outcomes

  1. Cost-effectiveness outcomes

    Time frame: 9, 13, 26 and 52 weeks

    Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire

  2. Self-reported health state

    Time frame: Baseline, 9, 13, 26, 52 weeks

    EQ-5D-5L is a generic health-related quality of life instrument

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial on the Effect of Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture. The Achilles Tendon Back-On-Track Study.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2021
Registry last updated
Jun 24, 2024

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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