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

Achilles Tendon Rupture Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04726189
• Other study ID #: N-20200041
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: November 2023

Study information

• Verified date: June 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: November 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital	Aalborg
Denmark	Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring	Hjørring

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Self-reported health state	EQ-5D-5L is a generic health-related quality of life instrument	Baseline, 9, 13, 26, 52 weeks
Primary	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	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
Secondary	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
Secondary	Achilles tendon resting angle (ATRA)	ATRA is validated as an indirect measure of the Achilles tendon length	13 and 52 weeks
Secondary	Achilles tendon length	Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)	9, 13 and 52 weeks
Secondary	Isometric muscle strength	maximal isometric plantar flexor muscle strength using a Fysiometer	9, 13 and 52 weeks
Secondary	Muscle endurance	Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)	13 and 52 weeks
Secondary	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
Secondary	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
Secondary	Compliance	The participants will register the number of exercise sessions they perform each day in a training journal.	9 weeks