Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000306910
Ethics application status
Approved
Date submitted
24/02/2020
Date registered
5/03/2020
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in Achilles tendon volume in response to different calf exercises among people with midportion tendinopathy and healthy people
Scientific title
The immediate changes in Achilles tendon biomechanical properties in response to different isometric protocols among people with midportion tendinopathy and healthy controls
Secondary ID [1] 300639 0
Nill
Universal Trial Number (UTN)
U1111-1248-7314
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 316419 0
Condition category
Condition code
Musculoskeletal 314676 314676 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 314677 314677 0 0
Physiotherapy
Injuries and Accidents 314678 314678 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 3 isometric protocols with different load parameters will be performed by each participant in the two trial groups (healthy and midportion) in a random sequence. the participant will perform one isometric protocol per session and interval between each session is one week. intervention is isometric contractions performed on a custom-built dynamometer in the physiology laboratory located at Clayton campus of Monash University.
they will be seated on the dynamometer, hip flexed 120 degrees, knee extended and foot in neutral position supported on the footplate.
protocol 1: subjects will perform isometric contractions and ramp-up within 1 sec. and hold the contraction for 1 sec at 75% MVC level. The duration of this intervention will be approximately 10-12 minutes.
protocol 2: subjects will ramp-up within 1 sec. and hold the contraction for 7 sec. at 75% MVC level. The approximate duration for this intervention is 20 minutes.
protocol 3: subject will ramp-up within 1 sec. and hold the contraction for 7 sec. at 35% MVC level. The approximate duration for this intervention is 20 minutes.

for all protocols, subjects will do 4 sets of 10 repetitions. the rest time between sets is 3 minutes and between repetitions is 10 sec.
visual feedback (monitor) will be in front of the subject and the exercise parameter will be guided by software guidelines.

the researcher (Eman Merza) who is a PhD candidate will supervise and administers the protocols.
this is a short-term intervention and adherence or fidelity is not assessed.
Intervention code [1] 316970 0
Rehabilitation
Comparator / control treatment
control group is healthy matched subjects that will perform the same 3 isometric protocols.
Control group
Active

Outcomes
Primary outcome [1] 323002 0
free Achilles tendon volume on the affected side/or worst side for the MAT group and the dominant side for the healthy control group. using 3DUS, Achilles tendon will be scanned at rest while the subject is lying in the prone position on dynamometer and foot kept in a neutral position. a single sweep scan will be performed starting from calcaneus to gastrocnemius muscle-tendon junction. using Stradwin software, a 3d image of AT will be reconstructed from manually contoured slices.
Timepoint [1] 323002 0
baseline and immediately following each protocol
Primary outcome [2] 323003 0
stiffness
the subject will perform multiple submaximal voluntary contractions while lying prone on the dynamometer. when they reach the targeted force level, they have to hold the contraction for 10 seconds to allow 3DUS scanning under contraction. tendon stiffness is calculated as the slope between PF force and corresponding elongation in free AT at each force level
Timepoint [2] 323003 0
baseline and immediately following each protocol
Primary outcome [3] 323004 0
the cross-sectional area of the free Achilles tendon will be assessed on the affected side/or worst side for the MAT group and the dominant side for the healthy control group. using 3DUS, Achilles tendon will be scanned at rest while the subject is lying in the prone position on dynamometer and foot kept in a neutral position. a single sweep scan will be performed starting from calcaneus to gastrocnemius muscle-tendon junction. using Stradwin software, manual contouring of slices every 5 mm will be performed and then transferred to MATLAB for further analysis.
Timepoint [3] 323004 0
baseline and immediately following each protocol
Secondary outcome [1] 380503 0
The pressure pain threshold will be assessed using an algometer. this is done on the affected or worst side for the MAT group only while lying in a prone position
Timepoint [1] 380503 0
baseline and immediately following each protocol

Eligibility
Key inclusion criteria
inclusion criteria for MAT group
i)Male participants, aged from 18 to 70, ii) diagnosed with Achilles tendinopathy (midportion) based on the following criteria: a)Pain localized to the tendon (2-7cm above the calcaneum), b)Pain during or after Achilles loading (e.g. walking, running), c) Morning stiffness or pain on movement after rest, d) Ultrasound confirmation of midportion Achilles pathology (tendon thickening, hypoechoic regions), iii) history of Achilles pain > 3months, iv) Ankle joint examination, and especially passive plantar-flexion are essentially normal, v) score of <70 on the VISA-A questionnaire, vi) be willing not to receive any physical therapy or other treatment for their Achilles tendon pain during the study period (3 weeks), vii) be willing to attend the laboratory setting 3 times with one week interval between sessions to perform the isometric exercise interventions. viii)Fluent in both written and spoken English, and ix) Able to provide informed written consent.

Inclusion criteria for healthy controls:
i)healthy male participants, ii) aged from 18 to 70, iii) Fluent in both written and spoken English, and iv) Able to provide informed written consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
exclusion criteria for MAT group
i) Exercise treatment for Achilles tendon pain within the last 3 months, ii) Previous Achilles injection in the last 3 months, iii) History of Achilles rupture, iv) Surgery for Achilles tendinopathy, v) Systemic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis), vi) Inherited connective tissue disorders (e.g Marfan’s syndrome), vii) People diagnosed with hypermobility joint syndrome (e.g. Ehlers-Danlos syndrome), viii) History of musculoskeletal injury of the affected lower limb in the last 6 to 12 months (ankle, knee or hip injury/pathology),ix) Injury or pathology to the spine that may interfere with execution of the exercise interventions in the study, xii) Participants undertaking antibiotic treatment in the last three months from start of recruitment (Fluoroquinolone antibiotics)., and xiii) Participants on cholesterol-lowering medications (Statins) in the last two years.

Exclusion criteria for healthy controls:
i)Participants with structural abnormalities in AT detected in the diagnostic ultrasound (tendon thickening, areas with hypoechogenicity), ii) history of lower limb injury and pathology of the dominant side in the last 6-12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the allocation sequence will be computer-generated (www.sealedenvelope.com) and entered into sealed opaque envelopes by a researcher not directly involved in the trial at a remote location
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
repeated measure design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will be powered to detect change in the primary outcome, tendon volume. There are no prior studies that have investigated volume change after isometric exercise. Assuming a large-sized effect of d=0.8, we would need 12 participants in our repeated measures design to detect a difference between two tasks (alpha=0.05, power=80%). In the between group comparison, we would need 21 participants so we will power for this analysis, thereby, a total sample size of 42 participants (21 MAT group and 21 healthy controls)

Two-way mixed ANOVA (time x group) will be used to investigate within and between group effects as well as interaction effects for the key outcomes (tendon stiffness at a given torque level, tendon volume). All statistical analysis will be conducted using SPSS statistical software with significance levels set at P> 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29471 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 305063 0
University
Name [1] 305063 0
Monash University
Country [1] 305063 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Peter Malliaras
Address
Department of physiotherapy, Building B,
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science.
Monash University
PO Box 527 Frankston
VIC 3199
Country
Australia
Secondary sponsor category [1] 305428 0
Individual
Name [1] 305428 0
Miss Eman Merza
Address [1] 305428 0
PhD candidate
Department of physiotherapy, Building B,
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science.
Monash University
PO Box 527 Frankston
VIC 3199
Country [1] 305428 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305449 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 305449 0
Monash University
PO Box 527 Frankston
VIC 3199
Ethics committee country [1] 305449 0
Australia
Date submitted for ethics approval [1] 305449 0
Approval date [1] 305449 0
03/09/2019
Ethics approval number [1] 305449 0
21356

Summary
Brief summary
Aim: To investigate acute changes in tendon volume and stiffness following different isometric load protocols among people with Achilles tendinopathy and healthy controls.
setting: The proposed study will be conducted in the physiology laboratory located in Clayton campus of Monash University.
participants: total number of 42 male participants (21 with midportion tendinopathy and 21 healthy matched), recruited from community.
intervention: 3 different isometric protocols with different parameters performed on a custom-built dynamometer. the protocols have different load intensity and duration of contraction. each subject in the 2 groups will perform a single protocol per session and the interval between each session is one week.
outcome measures: tendon volume, cross-sectional area, and stiffness will be measured at baseline and immediately following intervention using freehand 3-dimensional ultrasoud.
secondary outcome: pressure pain threshold measured at baseline and immediately following interventions.
discussion: the study will determine if a specific combination of load parameters could maximize volume changes among people with midportion tendinopathy and healthy controls
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100426 0
A/Prof Peter Malliaras
Address 100426 0
Department of Physiotherapy
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health science
Monash University, PO Box 527 Frankston
VIC 3199
Country 100426 0
Australia
Phone 100426 0
+61 399044502
Fax 100426 0
Email 100426 0
[email protected]
Contact person for public queries
Name 100427 0
A/Prof Peter Malliaras
Address 100427 0
Department of Physiotherapy
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health science
Monash University, PO Box 527 Frankston
VIC 3199
Country 100427 0
Australia
Phone 100427 0
+61 399044502
Fax 100427 0
Email 100427 0
[email protected]
Contact person for scientific queries
Name 100428 0
A/Prof Peter Malliaras
Address 100428 0
Department of Physiotherapy
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health science
Monash University, PO Box 527 Frankston
VIC 3199
Country 100428 0
Australia
Phone 100428 0
+61 399044502
Fax 100428 0
Email 100428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.