Abstract
BackgroundModifying variables in exercise prescription can produce specific effects on Achilles tendinopathy outcomes. This study aims to determine the feasibility of conducting an adequately powered randomised trial in the future to assess the efficacy of different load intensity and time-under-tension exercise parameters for improving pain and function in individuals with persistent midportion Achilles tendinopathy.MethodsThe trial is designed as prospective, four-armed feasibility and randomised pilot trial with 3 months follow-up. Interventions will be provided in a gym setting. The investigator, who will be blind to the allocation of participants, will conduct all pre- and post-intervention assessments. Forty-eight male participants with Achilles tendinopathy will be recruited from the community. We will use a 2 × 2 factorial design with factors of load intensity (six or eighteen repetitions maximum) and time-under-tension (two or six second repetitions). Participants will be randomised into one of the testing groups: six RM with two second repetitions, six RM with six second repetitions, eighteen RM with two second repetitions or eighteen RM with six second repetitions. Trial feasibility will be indicated by the rate of conversion, recruitment and retention, adherence to the interventions by participants, the utility of videoconferencing mode for weekly exercise supervision, incidence of adverse events, and feasibility of future economic evaluation. The secondary clinical outcomes will assess pain and disability, participant impression of change, satisfaction, health-related quality of life, physical activity, work absenteeism, psychological measures at baseline, 6 and 12 weeks, and plantarflexor contractile dysfunction (torque, rate of force development and muscle force steadiness) at baseline and 12 weeks. These clinical outcomes are primarily measured to provide information regarding potential treatment effects and trends.DiscussionThe proposed study and follow-up powered randomised trial will be a first step towards determining exercise dose parameters that may optimise outcomes for Achilles tendinopathy. We have chosen to focus on load intensity and time-under-tension, as these parameters are important for tendon adaptation. This work has the potential to lead to more effective exercise loading interventions for Achilles tendinopathy.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12618001315202. Registered retrospectively on August 6th, 2018.
Highlights
MethodsThe trial is designed as prospective, four-armed feasibility and randomised pilot trial with 3 months follow-up
Modifying variables in exercise prescription can produce specific effects on Achilles tendinopathy outcomes
The proposed study and follow-up powered randomised trial will be a first step towards determining exercise dose parameters that may optimise outcomes for Achilles tendinopathy
Summary
Trial design LOADIT is a four-arm, factorial randomised pilot study with a nested qualitative study. The videoconference care provider will collect adherence, health-care use, and adverse events data via questionnaire (Fig. 1) They will observe and record the first set of each exercise— standing and seated on the right and left sides—without providing any feedback, assessing exercise fidelity. (i) Pain and disability: The severity of pain and disability will be assessed using VISA-A, a disease-specific tool with acceptable construct validity and test-retest reliability [35] This outcome includes pain, function and activity domains, the total score ranging from zero to one hundred (the latter indicating no symptoms and full function).
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