Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121377
• Other study ID #: N-20180072
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: October 2020
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.

Description:

Regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after Achilles tendon rupture is found up to 10 years later. The majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports.

There has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. In general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises.

The primary aim is to test the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acute Achilles tendon rupture treated non-surgically

• Diagnosed and treatment initiated within 3 days of injury

• Age 18-65, able and willing to participate in the intervention

• Able to speak and understand Danish

Exclusion Criteria:

• Insertional Achilles tendon rupture on calcaneus or rupture 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 Fluoroquinolones or Corticosteroids within the last 6 months

• Diabetes

• 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:
• Resistance training
Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.

Locations

Country	Name	City	State
Denmark	Physiotherapy and Occupational Therapy, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	The participants will rate their acceptability (willingness) to perform the exercises on a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the patient's symptoms have improved to normal physical function or any other satisfactory level at the specific time, but if it matches, their expectations of the content of an exercise program in this early phase and how they tolerate performing the exercises. The intervention program is categorised as "Unacceptable" if rated as the three lower scores ("very unacceptable" to "slightly unacceptable") and categorised as "Acceptable" if rated as the four higher scores ("neither acceptable or unacceptable" to "very acceptable"). The exercise program is considered feasible if acceptability of the exercise program is 80%. Defined as: =13/16 patients will rate the acceptability of the intervention as "acceptable".	At 10 week follow-up
Primary	Compliance	The participants will register the number of training sessions and exercises they perform each day in a training journal. The compliance is measured as the mean number of exercise sessions they perform. The timeframe will be from the day they start the exercises to the end of week 9. The exercise program is considered feasible if the adherence to the exercise program is 50%. Defined as: =13/16 patients will perform = 50% of the exercise sessions possible from start to end of week 9.	At 10 week follow-up
Secondary	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". During the exercise intervention period and at 3 months follow,up the patients will fill out the score and subsequently they are asked to rate the appropriateness of the score on a 7 point Likert scale ranging from "strongly disagree" to "strongly agree".	At 2 and 10 weeks and at 3 months
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 for a pre-rupture level and at 3 months
Secondary	Physical Activity	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 for a pre-rupture level and at 3 months
Secondary	Achilles tendon resting angle (ATRA)	Indirect measure of the Achilles tendon length. It is measured in degrees between the axis of the fibula (from malleol to proximal head) and the line from the tip of the fibula to the head of the Fifth metatarsal bone.	At 10 weeks and at 3 months
Secondary	Achilles tendon length	Ultrasound measure of achilles tendon length.,	At 10 weeks and 3 months
Secondary	Achilles tendon cross-sectional area	Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site	At 10 weeks and 3 months
Secondary	Delay in start of exercise	Delay in starting the exercise program is measured in days drom start to end of week 9	At 10 weeks
Secondary	Adverse events	The number of serious and minor adverse events is registered using open questions and a pre-defined list.	At 10 weeks and 3 months
Secondary	Muscle endurance	Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)	At 3 months