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

NCT04726189 | Completed DMC

• 1 other identifier: N-20200041
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon rupture; Early functional rehabilitation; Resistance training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Achilles tendon total rupture score ATRS

  Baseline, 26 and 52 weeks

• International Physical Activity Questionnaire (IPAQ)

  baseline, 13, 26 and 52 weeks

• Achilles tendon resting angle (ATRA)

  13 and 52 weeks

• Achilles tendon length

  9, 13 and 52 weeks

• Isometric muscle strength

  9, 13 and 52 weeks

Other Outcomes (2)

• Cost-effectiveness outcomes

  9, 13, 26 and 52 weeks

• Self-reported health state

  Baseline, 9, 13, 26, 52 weeks

Study Arms (2)

Standard care exercises

ACTIVE COMPARATOR

This is the currently used treatment in the nine weeks of immobilisation with an orthosis.

Other: Standard exercises

Early progressive strength exercise

EXPERIMENTAL

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

Interventions

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 care exercises

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.

Early progressive strength exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (2)

Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring

Hjørring, 9800, Denmark

Location

Study Officials

• Marianne Christensen, MHSc

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PHD student

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 27, 2021
• Study Start: March 19, 2021
• Primary Completion: January 30, 2023
• Study Completion: November 23, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the 1 year follow-up
• Access Criteria: Researchers that provide a methodologically sound plan

Locations

DK (2)