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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Other: Standard exercises; Other: Standard exercises plus Early progressive exercises

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital
  • Hjørring, Denmark, 9800
    • Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles tendon total rupture score ATRS	Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles tendon total rupture score ATRS	Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.	Baseline, 26 and 52 weeks
International Physical Activity Questionnaire (IPAQ)	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)	baseline, 13, 26 and 52 weeks
Achilles tendon resting angle (ATRA)	ATRA is validated as an indirect measure of the Achilles tendon length	13 and 52 weeks
Achilles tendon length	Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)	9, 13 and 52 weeks
Isometric muscle strength	maximal isometric plantar flexor muscle strength using a Fysiometer	9, 13 and 52 weeks
Muscle endurance	Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)	13 and 52 weeks
The fear of re-rupture	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".	9, 13 and 52 weeks
Adverse events	The number of serious and minor adverse events is registered in a pre-defined list based on Common Terminology Criteria for Adverse Events	9, 13 and 52 weeks
Compliance	The participants will register the number of exercise sessions they perform each day in a training journal.	9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness outcomes	Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire	9, 13, 26 and 52 weeks
Self-reported health state	EQ-5D-5L is a generic health-related quality of life instrument	Baseline, 9, 13, 26, 52 weeks

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Resistance training; Achilles tendon rupture; Early functional rehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: N-20200041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon reasonable request
• IPD Sharing Time Frame: After completion of the 1 year follow-up
• IPD Sharing Access Criteria: Researchers that provide a methodologically sound plan
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No