Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.
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|ClinicalTrials.gov Identifier: NCT04726189|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendon Rupture||Other: Standard exercises Other: Standard exercises plus Early progressive exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||March 19, 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||June 2023|
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.
- Achilles tendon total rupture score ATRS [ Time Frame: 13 weeks ]Validated patient reported outcome measure. It contains 10 questions about physical performance in an 11-point Likert scale from zero to ten.
- Achilles tendon total rupture score ATRS [ Time Frame: 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.
- International Physical Activity Questionnaire (IPAQ) [ Time Frame: 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 resting angle (ATRA) [ Time Frame: 13 and 52 weeks ]ATRA is validated as an indirect measure of the Achilles tendon length
- Achilles tendon length [ Time Frame: 9, 13 and 52 weeks ]Ultrasound measure of achilles tendon length using Copenhagen Achilles length measure (CALM)
- Isometric muscle strength [ Time Frame: 9, 13 and 52 weeks ]maximal isometric plantar flexor muscle strength using a Fysiometer
- Muscle endurance [ Time Frame: 13 and 52 weeks ]Muscle endurance is measured in seated or standing heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
- The fear of re-rupture [ Time Frame: 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".
- Adverse events [ Time Frame: 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
- Compliance [ Time Frame: 9 weeks ]The participants will register the number of exercise sessions they perform each day in a training journal.
- Cost-effectiveness outcomes [ Time Frame: 9, 13, 26 and 52 weeks ]Work Productivity and Activity Impairment Questionnaire WPAI:GH and condition-related expenses as measured by a self-developed questionnaire
- Self-reported health state [ Time Frame: Baseline, 9, 13, 26, 52 weeks ]EQ-5D-5L is a generic health-related quality of life instrument
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726189
|Contact: Marianne Christensen, MHSc||+45 email@example.com|
|Orthopeadic department, Physiotherapy and Occupational Therapy, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Marianne Christensen +45 97662324 firstname.lastname@example.org|
|Orthopeadic department, Physiotherapy and Occupational Therapy, North Denmark Regional Hospital Hjørring||Recruiting|
|Hjørring, Denmark, 9800|
|Contact: Marianne Christensen +45 97662324 email@example.com|
|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|