Fatmah Hasani1,2, Terry Haines3, Shannon E Munteanu4,5, Peter Schoch6,7,8, Bill Vicenzino9, Peter Malliaras10. 1. Physiotherapy Department, School of Primary and Allied Health Care, Monash University, Frankston, Melbourne, Victoria, 3199, Australia. fatmah.hasani@monash.edu. 2. Physiotherapy Department, Security Forces Hospital, Riyadh, 11481, Kingdom of Saudi Arabia. fatmah.hasani@monash.edu. 3. School of Primary and Allied Health Care, Faculty of Medicine, Nursing, and Health Sciences, Monash University, Frankston, Victoria, 3199, Australia. 4. Discipline of Podiatry, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, 3086, Australia. 5. La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, 3086, Australia. 6. McKenzie Institute Australia, Beaumaris, Victoria, 3193, Australia. 7. McKenzie Institute International, Raumati Beach, 5032, New Zealand. 8. Physiotherapy Department, Barwon Health, Geelong, 3220, Australia. 9. Sports Injuries Rehabilitation and Prevention for Health Research Unit, The University of Queensland, School of Health and Rehabilitation Sciences, Brisbane, Queensland, Australia. 10. Physiotherapy Department, School of Primary and Allied Health Care, Monash University, Frankston, Melbourne, Victoria, 3199, Australia.
Abstract
BACKGROUND: One potential reason for disparate outcomes of exercise for Achilles tendinopathy is poor knowledge about whether exercise parameters (i.e. different exercise doses) influence outcome. Whether parameters that are important for tendon adaptation influence clinical outcomes in Achilles tendinopathy has not been investigated. Therefore, this research aimed to assess the feasibility of conducting a fully powered randomised trial to investigate the efficacy of different load-intensity and time-under-tension exercise parameters for Achilles tendinopathy. METHODS: A factorial four-arm, randomised trial. Forty-eight male participants (18-70 years old) with mid-portion Achilles tendinopathy (≥ 3 months) were recruited. Participants were randomly allocated to high (6 repetition maximum) or low intensity (18 repetition maximum) exercise, performed with either high (6 s per cycle) or low (2 s per cycle) time-under-tension. Participants performed 12-weeks of standing and seated calf raise exercises three times per week in a gym setting using a Smith machine. One session per week was supervised (via videoconference). Primary feasibility outcomes (recruitment and retention rate, exercise adherence and fidelity [i.e. time-under-tension, volume, load intensity], incidence of adverse events, health care use and productivity cost) were collected weekly. Means and standard deviations were determined for parametric data, medians and interquartile range for non-parametric continuous data, and frequency counts for discrete data. RESULTS:Total recruitment (76%) and retention (90%) rates were high. Exercise adherence ranged from 45 to 63% and fidelity ranged from 8 to 83% across the groups. Thirty-one participants reported 64 adverse events over the 3 months. Twenty-one participants (70%) reported mild events. Participants reported reduced presenteeism more than absenteeism. CONCLUSIONS: A fully powered trial is feasible. The proposed trial design and interventions demonstrated acceptable recruitment and retention rates and safety profile. However, exercise fidelity and adherence to the gym-based intervention was not acceptable. Strategies to improve intervention adherence and fidelity should be considered in future trials. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001315202 . Registered retrospectively on August 6th, 2018.
RCT Entities:
BACKGROUND: One potential reason for disparate outcomes of exercise for Achilles tendinopathy is poor knowledge about whether exercise parameters (i.e. different exercise doses) influence outcome. Whether parameters that are important for tendon adaptation influence clinical outcomes in Achilles tendinopathy has not been investigated. Therefore, this research aimed to assess the feasibility of conducting a fully powered randomised trial to investigate the efficacy of different load-intensity and time-under-tension exercise parameters for Achilles tendinopathy. METHODS: A factorial four-arm, randomised trial. Forty-eight male participants (18-70 years old) with mid-portion Achilles tendinopathy (≥ 3 months) were recruited. Participants were randomly allocated to high (6 repetition maximum) or low intensity (18 repetition maximum) exercise, performed with either high (6 s per cycle) or low (2 s per cycle) time-under-tension. Participants performed 12-weeks of standing and seated calf raise exercises three times per week in a gym setting using a Smith machine. One session per week was supervised (via videoconference). Primary feasibility outcomes (recruitment and retention rate, exercise adherence and fidelity [i.e. time-under-tension, volume, load intensity], incidence of adverse events, health care use and productivity cost) were collected weekly. Means and standard deviations were determined for parametric data, medians and interquartile range for non-parametric continuous data, and frequency counts for discrete data. RESULTS: Total recruitment (76%) and retention (90%) rates were high. Exercise adherence ranged from 45 to 63% and fidelity ranged from 8 to 83% across the groups. Thirty-one participants reported 64 adverse events over the 3 months. Twenty-one participants (70%) reported mild events. Participants reported reduced presenteeism more than absenteeism. CONCLUSIONS: A fully powered trial is feasible. The proposed trial design and interventions demonstrated acceptable recruitment and retention rates and safety profile. However, exercise fidelity and adherence to the gym-based intervention was not acceptable. Strategies to improve intervention adherence and fidelity should be considered in future trials. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001315202 . Registered retrospectively on August 6th, 2018.