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Trial registered on ANZCTR


Registration number
ACTRN12618001315202
Ethics application status
Approved
Date submitted
26/07/2018
Date registered
6/08/2018
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of different calf exercises on pain and function in Achilles tendinopathy: a protocol for a pilot and feasibility trial (the LOADIT trial)

Scientific title
LOAD Intensity and Time-under-tension in the management of chronic mid-portion Achilles tendinopathy: a protocol for a pilot and feasibility trial (the LOADIT trial)
Secondary ID [1] 292943 0
Nill
Universal Trial Number (UTN)
U1111-1202-4671
Trial acronym
LOADIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 304832 0
Condition category
Condition code
Musculoskeletal 304132 304132 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 304133 304133 0 0
Physiotherapy
Injuries and Accidents 307958 307958 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total of 4 arms included in this study will perform two isotonic calf rising exercises that load the calf-Achilles complex. The first two arm is the low load group where participants will perform 4 sets of 18 repetitions per set prior to failure (i.e. inability to do another full repetition) with high and low time under tension. The second two arm is the high load group where participants will perform 4 sets of 6 repetitions per set prior to failure with high and low time under tension. Time under tension in this context refers to the how long the calf tendon is under strain.

The high and low load exercise groups with high time under tension will perform the exercise with the same slow tempo of 6 s per repetition (3 seconds concentric phase, 3 seconds eccentric phase, without pause in between). It means participants are required to complete the reps in a set time in 144 and 432 seconds, respectively.
While the high and low load exercise groups with low time under tension will perform the exercise with the same slow tempo of 2 s per repetition (1second concentric phase, 1 second eccentric phase, without pause in between). Participants are required to complete the reps in a set time in 48 and 144 seconds, respectively. The exercise will be timed using an audible metronome phone application that will be downloaded to the participant’s phone.
The rest time between sets is 2 min and 4-5 min between exercises from standing and setting position. Both the knee straight and knee bent calf raises will be performed on a Smith machine for all groups 3 times a week for 12 weeks. Participants will perform exercises at their local gymnasium (if they have a current membership) or at the Sports Facility at Monash University. To maximize adherence, one-on-one session per week will be monitored via videoconference (Zoom) by a practicing physiotherapist.
Intervention code [1] 299178 0
Rehabilitation
Intervention code [2] 302018 0
Treatment: Other
Comparator / control treatment
high load with high time under tension arm ( 6 RM with 6 s per rep group) is the comparator group.
Control group
Dose comparison

Outcomes
Primary outcome [1] 303452 0
As this is a feasibility trial, the main analysis will focus on process outcomes. This will include the recruitment rate.

The recruitment rate will be calculated as the total number of participants recruited divided by total number of months that the trial recruited for.
Timepoint [1] 303452 0
Baseline up to 6 months of recruitment window
Primary outcome [2] 306940 0
Exercise adherence will be assessed at the weekly videoconference session and is defined as the percentage of prescribed exercise sessions completed or attempt the session per week
Timepoint [2] 306940 0
From baseline to week-12
Primary outcome [3] 306941 0
Exercise fidelity will be assessed by calculating the proportion of participants that performed all completed sessions as prescribed

Timepoint [3] 306941 0
From Week-1 to week-12
Secondary outcome [1] 338958 0
Response rate to clinical outcomes (i.e. patient rated measures) including pain and function, Assessed with the Victorian Institute of Sports Assessment – Achilles questionnaire (VISA-A)


Timepoint [1] 338958 0
Baseline, Week-6, and Week-12
Secondary outcome [2] 350028 0
Physiotherapists’ experiences with the utilisation of the videoconferencing mode to monitor the intervention will be measured qualitatively i.e.. face to face or online 30 min to 45 min semi-structured interview.
Timepoint [2] 350028 0
After week 12
Secondary outcome [3] 350162 0
Incidence of adverse events i.e. the frequency (number of cases), type (e.g. rolled ankle, muscle tear or tendon pain worsening) and severity (mild, moderate or severe)
This will be recorded by a physiotherapist at the weekly videoconference supervised session
Timepoint [3] 350162 0
From week-1 to week-12
Secondary outcome [4] 350164 0
Retention rate i.e. ratio of the number of retained participants at 12 weeks to the number at baseline
Timepoint [4] 350164 0
Baseline , Week-6 and Week-12
Secondary outcome [5] 350173 0
Health-related quality of life assessed by 5-level EQ-5D version questionnaire (EQ 5D 5L)
Timepoint [5] 350173 0
Baseline, Week-6, and Week-12
Secondary outcome [6] 350174 0
Physical activity assessed by International Physical Activity Questionnaire (IPAQ)
Timepoint [6] 350174 0
Baseline, Week-6, and Week-12
Secondary outcome [7] 350175 0
Kinesiophobia assessed by Tampa Scale for Kinesiophobia (TSK)
Timepoint [7] 350175 0
Baseline, Week-6, and Week-12
Secondary outcome [8] 350177 0
Pain catastrophic thinking assessed by Pain Catastrophising Questionnaire ( PCQ)
Timepoint [8] 350177 0
Baseline, Week-6, and Week-12
Secondary outcome [9] 350178 0
Work productivity assessed by Work Productivity and Activity Impairment Questionnaire (WPAIQ)
Timepoint [9] 350178 0
From baseline to week-12
Secondary outcome [10] 350180 0
Global satisfaction assessed by Patient Global of Change (GOC) 7-point Likert scale
Timepoint [10] 350180 0
Week-6 and Week-12
Secondary outcome [11] 350183 0
Performance outcome including Plantarflexors rated of force development that will be measured by a custom made dynamometer.
Timepoint [11] 350183 0
Baseline and week-12
Secondary outcome [12] 350184 0
Performance outcome including Planterfelxors constant force at 10% of the maximum isometric contraction will be measured by a custom made dynamometer.
Timepoint [12] 350184 0
Baseline and week-12
Secondary outcome [13] 350307 0
Primary outcome: Eligibility rate will be calculated as the total number of participants contacted divided by number of consents.
Timepoint [13] 350307 0
Baseline up to 6 months of recruitment window
Secondary outcome [14] 350308 0
Primary outcome: Change in exercise fidelity
The telerehabilitation assessor will record the first set of calf exercise prior to providing any fidelity feedback. The proportion of the 48 participants that display training errors (including improper calf raising, foot position, etc will be compared across the three assessments
Timepoint [14] 350308 0
Week-1, week-6 and week-12
Secondary outcome [15] 350309 0
Participants’ experiences with the interventions and weekly videoconferencing supervised sessions will be measured qualitatively i.e.. face to face or online 30 min to 45 min semi-structured interview.
Timepoint [15] 350309 0
after week-12

Eligibility
Key inclusion criteria
To be included in this study, participants must meet the following inclusion criteria:
• Male
• Aged 18-70 years
• Fluent in both written and spoken English
• Able to provide informed written consent
• Clinical diagnosis of mid-portion AT on one or both sides as determined by the satisfaction of the all following diagnostic criteria; insidious onset of pain 2-6 cm above the Achilles tendon insertion, pain with or after weight bearing activities and worse in the morning or upon weight bearing after a period of rest
• Achilles tendon ultrasound imaging showing increased anteroposterior thickness and/or hypoechoic regions and/or vascularization (Doppler signal) within the mid-portion of the Achilles tendon
• Score less than or equal 75 on the VISA-A questionnaire
• Greater than or equal to 12-week history of pain
• Be willing to access a gym three times per week to perform the exercise interventions
• Be willing not to receive any physical therapy or other treatments for their Achilles tendon pain during the study period
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants in this study will be:
• Previous Achilles tendon rupture or surgery
• Inflammatory arthritis (e.g. rheumatoid arthritis)
• Metabolic and endocrine disorders (e.g. type I or II diabetes)
• Neurological disorders (e.g. multiple sclerosis)
• Exercise treatment for Achilles tendon pain within the last 3 months
• Injection for Achilles tendon pain in the last 3 months
• Injury or pathology of the limbs or back that may interfere with execution of the exercise interventions in the study

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Means and standard deviation (or median and IQR where data is not normally distributed) and the mean differences (or median differences) and their 95% confidence intervals of all measures will be calculated at each follow-up time. Point estimates of effect will be calculated as the difference observed between group means expressed as proportion of the pooled standard deviation. The effect size criteria will be interpreted as per Hopkins (Hopkins 2000) with very large being greater than or equal to 1.2, moderate being greater than or equal to 0.6 small being greater than or equal to 0.2. Standard tests to assess continuous data for normal distribution will be used and transformation will be carried out if required for further analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 17578 0
3199 - Frankston
Recruitment postcode(s) [2] 17579 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 297569 0
University
Name [1] 297569 0
Monash University
Address [1] 297569 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 [1] 297569 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, McMahons Road
PO Box 527 Frankston Vic 3199

Country
Australia
Secondary sponsor category [1] 296580 0
Individual
Name [1] 296580 0
Ms Fatmah Hasani
Address [1] 296580 0
PhD candidate
Department of Physiotherapy, Building B
School of Primary and Allied Health Care
Faculty of Medicine, Nursing and Health Science
Monash University, McMahons Road
PO Box 527 Frankston Vic 3199
Country [1] 296580 0
Australia
Secondary sponsor category [2] 299722 0
Individual
Name [2] 299722 0
Professor Terry Haines
Address [2] 299722 0
Head of School, Building G
School of Primary and Allied Health Care
Monash University
Peninsula Campus, Monash University
McMahons Road
Frankston Victoria 3199
Country [2] 299722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298664 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 298664 0
Monash University, PO Box 527 Frankston Vic 3199
Ethics committee country [1] 298664 0
Australia
Date submitted for ethics approval [1] 298664 0
Approval date [1] 298664 0
31/10/2016
Ethics approval number [1] 298664 0
1366

Summary
Brief summary
Objectives: To determine the feasibility of conducting a future definitive randomised trial to assess the efficacy of specific load-intensity and time-under-tension exercise interventions for reducing pain in mid-portion Achilles tendinopathy.
Design: Single-centre, outcome assessor-blind, feasibility factorial randomised pilot trial.
Setting: Interventions provided in a university/ gym setting.
Participants: Total number of 48 male participants with Achilles tendinopathy, recruited from the community.
Interventions: Participants will be randomised into one of the four factorial arms that include high (6 repetitions to failure) or low (18 repetitions to failure) load-intensity calf exercise, and each will be performed with high (6 second per repetition) or low (2 seconds per repetition) time under tension. Exercise will be home-based and performed 3 times per week over 12 weeks. One exercise session per week will be monitored via telerehabilitation (videoconference).
Main outcome measure: The primary outcomes will be study processes used to determine feasibility of a future definitive randomised trial. Process outcomes will include recruitment and retention rates, adherence to interventions, response rates to self-reported questionnaire outcomes, adverse events, and participants’ and telerehabilitation observers’ experiences with the interventions. Clinical outcomes including patient rated pain, function, global satisfaction, health-related quality of life, physical activity, kinesiophobia, pain catastrophic thinking as well as measures of plantarflexion motor function will be collected to explore the rate of change over 6 and 12 weeks in patients while completing a loading protocol with varying parameters for mid-portion Achilles tendinopathy.
Discussion: This study will determine the feasibility of a future definitive randomised trial examining the efficacy of specific load-intensity and time-under-tension exercise interventions for Achilles tendinopathy.
Trial website
https://fatmahhasani.wixsite.com/loadit
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77818 0
A/Prof Peter Malliaras
Address 77818 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 77818 0
Australia
Phone 77818 0
+61 3 9904 4502
Fax 77818 0
Email 77818 0
peter.malliaras@monash.edu
Contact person for public queries
Name 77819 0
A/Prof Peter Malliaras
Address 77819 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 77819 0
Australia
Phone 77819 0
+61 3 9904 4502
Fax 77819 0
Email 77819 0
peter.malliaras@monash.edu
Contact person for scientific queries
Name 77820 0
A/Prof Peter Malliaras
Address 77820 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 77820 0
Australia
Phone 77820 0
+61 3 9904 4502
Fax 77820 0
Email 77820 0
peter.malliaras@monash.edu

No data has been provided for results reporting
Summary results
Not applicable