High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a Randomized Controlled Trial

Background Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age. Objective This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass. Methods We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models. Results We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021. Conclusions High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz. International Registered Report Identifier (IRRID) DERR1-10.2196/22989