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

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ClinicalTrials.gov Identifier: NCT04726189
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Marianne Christensen, Aalborg University Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Other: Standard exercises Other: Standard exercises plus Early progressive exercises Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard care exercises
This is the currently used treatment in the nine weeks of immobilisation with an orthosis.
Other: Standard exercises
Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.

Experimental: Early progressive strength exercise
This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration.
Other: Standard exercises plus Early progressive exercises
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726189


Contacts
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Contact: Marianne Christensen, MHSc +45 97662324 mc@rn.dk

Locations
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Denmark
Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Marianne Christensen    +45 97662324    mc@rn.dk   
Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring Recruiting
Hjørring, Denmark, 9800
Contact: Marianne Christensen    +45 97662324    mc@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Marianne Christensen, MHSc Aalborg University Hospital, Denmark
Study Chair: Inge Lunding Kjær, MD Aalborg University Hospital, Denmark
Study Chair: Jennifer A Zellers, PhD Washington University School of Medicine in St. Louis, USA
Study Chair: Karin Grävare Silbernagel, PhD University of Delaware, DE USA
Study Chair: Michael Skovdal Rathleff, PhD Aalborg University Hospital, Denmark
  Study Documents (Full-Text)

Documents provided by Marianne Christensen, Aalborg University Hospital:
Study Protocol and Informed Consent Form  [PDF] January 23, 2021

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Responsible Party: Marianne Christensen, PT, PHD student, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04726189    
Other Study ID Numbers: N-20200041
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available upon reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After completion of the 1 year follow-up
Access Criteria: Researchers that provide a methodologically sound plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marianne Christensen, Aalborg University Hospital:
Achilles tendon rupture
Early functional rehabilitation
Resistance training
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries