None listed
Conditions
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.
Interventions
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 und
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.
Sponsors
Associate Professor Peter Malliaras
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed