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

Primary Purpose

Achilles Tendon Rupture

Status

Active

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Standard exercises

Standard exercises plus Early progressive exercises

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles tendon rupture, Early functional rehabilitation, Resistance training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care exercises

Early progressive strength exercise

Arm Description

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

This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

Achilles tendon resting angle (ATRA)

ATRA is validated as an indirect measure of the Achilles tendon length

Achilles tendon length

Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)

Isometric muscle strength

maximal isometric plantar flexor muscle strength using a Fysiometer

Muscle endurance

Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)

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".

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

Compliance

The participants will register the number of exercise sessions they perform each day in a training journal.

Full Information

NCT ID

NCT04726189

First Posted

January 23, 2021

Last Updated

June 7, 2023

Sponsor

Aalborg University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04726189

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 19, 2021 (Actual)

Primary Completion Date

January 30, 2023 (Actual)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Achilles Tendon Rupture

Keywords

Achilles tendon rupture, Early functional rehabilitation, Resistance training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care exercises

Arm Type

Active Comparator

Arm Description

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

Arm Title

Early progressive strength exercise

Arm Type

Experimental

Arm Description

This exercise program initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration.

Intervention Type

Other

Intervention Name(s)

Standard exercises

Intervention Description

Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.

Intervention Type

Other

Intervention Name(s)

Standard exercises plus Early progressive exercises

Intervention Description

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 Measure Information:

Title

Achilles tendon total rupture score ATRS

Description

Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Achilles tendon total rupture score ATRS

Description

Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.

Time Frame

Baseline, 26 and 52 weeks

Title

International Physical Activity Questionnaire (IPAQ)

Description

Time Frame

baseline, 13, 26 and 52 weeks

Title

Achilles tendon resting angle (ATRA)

Description

ATRA is validated as an indirect measure of the Achilles tendon length

Time Frame

13 and 52 weeks

Title

Achilles tendon length

Description

Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)

Time Frame

9, 13 and 52 weeks

Title

Isometric muscle strength

Description

maximal isometric plantar flexor muscle strength using a Fysiometer

Time Frame

9, 13 and 52 weeks

Title

Muscle endurance

Description

Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)

Time Frame

13 and 52 weeks

Title

The fear of re-rupture

Description

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".

Time Frame

9, 13 and 52 weeks

Title

Adverse events

Description

The number of serious and minor adverse events is registered in a pre-defined list based on Common Terminology Criteria for Adverse Events

Time Frame

9, 13 and 52 weeks

Title

Compliance

Description

The participants will register the number of exercise sessions they perform each day in a training journal.

Time Frame

9 weeks

Other Pre-specified Outcome Measures:

Title

Cost-effectiveness outcomes

Description

Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire

Time Frame

9, 13, 26 and 52 weeks

Title

Self-reported health state

Description

EQ-5D-5L is a generic health-related quality of life instrument

Time Frame

Baseline, 9, 13, 26, 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials: