Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Primary Purpose
Achilles Tendon Rupture
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture
Eligibility Criteria
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)
Sites / Locations
- Physiotherapy and Occupational Therapy, Aalborg University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistance exercise program
Arm Description
Early resistance exercise sessions and home program
Outcomes
Primary Outcome Measures
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".
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.
Secondary Outcome Measures
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".
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.
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)
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.
Achilles tendon length
Ultrasound measure of achilles tendon length.,
Achilles tendon cross-sectional area
Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site
Delay in start of exercise
Delay in starting the exercise program is measured in days drom start to end of week 9
Adverse events
The number of serious and minor adverse events is registered using open questions and a pre-defined list.
Muscle endurance
Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Full Information
NCT ID
NCT04121377
First Posted
September 29, 2019
Last Updated
October 13, 2020
Sponsor
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04121377
Brief Title
Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Official Title
Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance exercise program
Arm Type
Experimental
Arm Description
Early resistance exercise sessions and home program
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability
Description
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".
Time Frame
At 10 week follow-up
Title
Compliance
Description
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.
Time Frame
At 10 week follow-up
Secondary Outcome Measure Information:
Title
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". 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".
Time Frame
At 2 and 10 weeks and at 3 months
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 for a pre-rupture level and at 3 months
Title
Physical Activity
Description
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)
Time Frame
Baseline for a pre-rupture level and at 3 months
Title
Achilles tendon resting angle (ATRA)
Description
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.
Time Frame
At 10 weeks and at 3 months
Title
Achilles tendon length
Description
Ultrasound measure of achilles tendon length.,
Time Frame
At 10 weeks and 3 months
Title
Achilles tendon cross-sectional area
Description
Ultrasound measure of cross-sectional area of the Achilles tendon at the rupture site
Time Frame
At 10 weeks and 3 months
Title
Delay in start of exercise
Description
Delay in starting the exercise program is measured in days drom start to end of week 9
Time Frame
At 10 weeks
Title
Adverse events
Description
The number of serious and minor adverse events is registered using open questions and a pre-defined list.
Time Frame
At 10 weeks and 3 months
Title
Muscle endurance
Description
Muscle endurance is measured in seated heel-rise with MuscleLab Measurement system (Ergotest Technology, Oslo, Norway)
Time Frame
At 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Christensen, MHSc
Organizational Affiliation
Physiotherapy and Occupational Therapy, Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy and Occupational Therapy, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available upon reasonable request
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Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
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