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

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Other: Standard exercises; Other: Standard exercises plus Early progressive exercises

• Registration Number: NCT04726189
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-27
• Study Start: 2021-03-19
• Primary Completion: 2023-01-30
• Study Completion: 2023-11-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care exercises	Standard exercises	This is the currently used treatment in the nine weeks of immobilisation with an orthosis.
Early progressive strength exercise	Standard exercises plus Early progressive exercises	This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration.

Primary Outcome Measures

Name	Time	Method
Achilles tendon total rupture score ATRS	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

Name	Time	Method
The fear of re-rupture	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".
Compliance	9 weeks	The participants will register the number of exercise sessions they perform each day in a training journal.
Achilles tendon resting angle (ATRA)	13 and 52 weeks	ATRA is validated as an indirect measure of the Achilles tendon length
Adverse events	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
International Physical Activity Questionnaire (IPAQ)	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)
Achilles tendon length	9, 13 and 52 weeks	Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)
Isometric muscle strength	9, 13 and 52 weeks	maximal isometric plantar flexor muscle strength using a Fysiometer
Muscle endurance	13 and 52 weeks	Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Achilles tendon total rupture score ATRS	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.

Trial Locations

Locations (2)

Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

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