Identifying responders versus non‐responders: Incorporation of controls is required for sound statistical inference

Padilla, Jaume; Leary, Emily; Limberg, Jacqueline K.

doi:10.1113/ep089142

Cited by 9 publications

(6 citation statements)

References 4 publications

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“…In an era of personalized lifestyle-based medicine and with an increase in the number of interventions focused on the interindividual variability of several cardiometabolic risk factors in response to exercise ( Alvarez et al, 2017 ; Solomon, 2018 ; Brennan et al, 2019 ; Ross et al, 2019 ; Hetherington-Rauth et al, 2020a ; Brennan et al, 2020b ), there is a clear need to have a control group to differentiate the inevitable within-subject random variability due to biological error and the technical error of measurement from the variability resulting from the exercise intervention. A major strength of the D2FIT study was its long-term RCT design in individuals with T2DM, which follows the recent consensus statement recommendations, highlighting the importance of using a control group ( Ross et al, 2019 ; Padilla et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function

et al. 2021

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Purpose: Little is known about the interindividual variability in fat mass (FM) loss in response to high-intensity interval training (HIIT) and moderate continuous training (MCT) in individuals with type 2 diabetes mellitus (T2DM). Moreover, the impact on health-related outcomes in those who fail to reduce FM is still unclear. The aims of this investigation were (1) to assess if the individuals with T2DM who FM differed across MCT, HIIT, and control groups over a 1-year intervention and (2) to assess the changes on glycemic control and vascular function in the exercising patients who failed to lose FM.Methods: Adults with T2DM were randomized into a 1-year intervention involving a control group (n=22), MCT with resistance training (RT; n=21), and HIIT with RT (n=19). FM was assessed using dual-energy X-ray absorptiometry and a change in total body FM above the typical error was used to categorize FM responders. Glycemic control and vascular stiffness and structure were assessed. A chi-square test and generalized estimating equations were used to model the outcomes.Results: Both MCT (n=10) and HIIT (n=10) had a similar proportion of individuals who were categorized as high responders for FM, with the percent change in FM on average −5.0±9.6% for the MCT and −6.0±12.1% for the HIIT, which differed from the control group (0.2±7.6%) after a 1-year intervention (p<0.05). A time-by-group interaction for carotid artery intima-media thickness (cIMT) (p for interaction=0.042) and lower-limb pulse wave velocity (LL PWV; p for interaction=0.010) between those categorized as low FM responders and the control group. However, an interaction was observed between the high responders for FM loss and controls for both brachial and carotid hemodynamic indices, as well as in cIMT, carotid distensibility coefficient, carotid beta index, and LL PWV (p for interactions <0.05). No interactions were found for glycaemic indices (p for interaction >0.05).Conclusion: Our results suggest that the number of FM responders did not differ between the MCT or HIIT, compared to the control, following a 1-year exercise intervention in individuals with T2DM. However, low responders to FM may still derive reductions in arterial stiffness and structure.Clinical Trial Registration: Comparing Moderate and High-intensity Interval Training Protocols on Biomarkers in Type 2 Diabetes Patients (D2FIT study) – number: NCT03144505 (https://clinicaltrials.gov/ct2/show/NCT03144505).

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Section: Discussionmentioning

confidence: 99%

Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function

et al. 2021

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“…In addition, we decided to hold constant the resting time for both training groups because they were also very similar in training volume. The RET exercises performed were the same measured during the 1RM testing (21–23,31) (Table 1). A workload adjustment was made by measuring 1RM for each exercise when the subjects completed 4 weeks of the RET program.…”

Section: Methodsmentioning

confidence: 99%

“…The 95% confidence intervals (95% CIs) for the statistic and the observed effect size (ES) were computed and interpreted as suggested by Hedges (15). Secondary analyses included a GLM univariate ANCOVA aimed at identifying responders vs. nonresponders by using the pretest FMD% values as a covariate to test whether baseline values of FMD% were associated with the experimental intervention (25). Subjects in the exercising groups who reached FMD% values equal or above the expected minimal change of 2.5% used for power analysis were considered responders.…”

Section: Methodsmentioning

confidence: 99%

Low-Intensity Resistance Training Improves Flow-Mediated Dilation in Young Hispanic Adults

Briceño-Torres

Carpio-Rivera

Solera-Herrera

et al. 2022

Journal of Strength and Conditioning Research

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Briceño-Torres, JM, Carpio-Rivera, E, Solera-Herrera, A, Forsse, J, Grandjean, PW, and Moncada-Jiménez, J. Low-intensity resistance training improves flow-mediated dilation in young hispanic adults. J Strength Cond Res 37(2): 298–304, 2023—The purpose of this study was to compare the effects of 2 resistance exercise training (RET) intensities on brachial artery flow-mediated dilatation (FMD) in sedentary males. Thirty-four men (age = 20.6 ± 1.8 years, height = 171.3 ± 5.2 cm, body mass = 65.2 ± 10.6 kg, and DXA fat mass = 22.3 ± 7.4%) were randomly assigned to a control group (no exercise CTRL, n = 12), RET at 50% of 1 repetition maximum (1RM) (RET50%, n = 12), and RET at 80% 1RM (RET80%, n = 10). The RET program was performed twice per week for 8 weeks; subjects performed the same RET exercises at similar total workloads (1920 arbitrary units [AUs] for the RET80% and 1950 AUs for the RET50%). The FMD% was measured before and after 8 weeks by ultrasound. Mixed factorial analysis of variance (3 groups × 2 measurements), effect size (ES), and 95% confidence intervals (95% CIs) were computed for FMD%. The level of significance was set at p ≤ 0.05. A significant increase (p = 0.001) was found on post-test FMD% in RET50% (mean = 9.9 ± 3.7%, ES = 1.9, and 95% CIs = 2.8–0.9) compared with CTRL (mean = 5.7 ± 1.7%, ES = 0.2, and 95% CIs = −0.4 to 0.8), and there were no significant differences found between RET50% and RET80% and between RET80% and CTRL. Results support the concept of training specificity and provide preliminary evidence that lower resistance and higher repetition RET elicit greater short-term reduced endothelium dysfunction than higher intensity RET at similar training volume.

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“…An important part of the analysis of interindividual response variability is the classification of responsiveness (e.g., being a responder or non-responder). This point has been extensively discussed in more detail elsewhere, and several methods have been proposed to analyze interindividual variability (Atkinson and Batterham, 2015;Hecksteden et al, 2015Hecksteden et al, , 2018bBonafiglia et al, 2016Bonafiglia et al, , 2018Bonafiglia et al, , 2019Bonafiglia et al, , 2021aSwinton et al, 2018;Atkinson et al, 2019;Voisin et al, 2019;Dankel and Loenneke, 2020a,b;Tenan et al, 2020;Padilla et al, 2021;Sainani et al, 2021). In this context, others prefer a characterization of responsiveness using a more statistical viewpoint (e.g., probability or likelihood of response; Walsh et al, 2020a,b).…”

Section: Considerations Regarding the Statistical Analysismentioning

confidence: 99%

Causes and Consequences of Interindividual Response Variability: A Call to Apply a More Rigorous Research Design in Acute Exercise-Cognition Studies

Herold

Törpel²,

Hamacher

et al. 2021

Front. Physiol.

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The different responses of humans to an apparently equivalent stimulus are called interindividual response variability. This phenomenon has gained more and more attention in research in recent years. The research field of exercise-cognition has also taken up this topic, as shown by a growing number of studies published in the past decade. In this perspective article, we aim to prompt the progress of this research field by (i) discussing the causes and consequences of interindividual variability, (ii) critically examining published studies that have investigated interindividual variability of neurocognitive outcome parameters in response to acute physical exercises, and (iii) providing recommendations for future studies, based on our critical examination. The provided recommendations, which advocate for a more rigorous study design, are intended to help researchers in the field to design studies allowing them to draw robust conclusions. This, in turn, is very likely to foster the development of this research field and the practical application of the findings.

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Identifying responders versus non‐responders: Incorporation of controls is required for sound statistical inference

Cited by 9 publications

References 4 publications

Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function

Interindividual Variability in Fat Mass Response to a 1-Year Randomized Controlled Trial With Different Exercise Intensities in Type 2 Diabetes: Implications on Glycemic Control and Vascular Function

Low-Intensity Resistance Training Improves Flow-Mediated Dilation in Young Hispanic Adults

Causes and Consequences of Interindividual Response Variability: A Call to Apply a More Rigorous Research Design in Acute Exercise-Cognition Studies

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