How to write a research study protocol

A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort. In this paper, we will describe how to write a research study protocol.

Study protocol: prevalence of low energy availability and its relation to health and performance among female football players

Enduring low energy availability (LEA) is associated with several potentially serious physiological and mental conditions. LEA has been found highly prevalent among female elite athletes within endurance sports, thus hampering athletes’ health and performance. The prevalence and the underpinning risk factors of LEA among female elite football players are less studied. One reason is that the existing self-report measures and technological devices to monitor energy intake and expenditure are inadequately adapted to capture the nature of the physical activity and energy expenditure among football players and are thus inaccurate.The present paper outlines a study protocol addressing the prevalence of LEA, the measurement of LEA and the correlations of LEA in terms of health and performance in female football players. Four studies will be conducted with the following aims (1) to evaluate the accuracy of global positioning systems (GPS)-based devices to monitor energy expenditure with indirect calorimetry as the gold standard, (2) to assess energy intake, quantify energy expenditure and investigate energy availability through self-report instruments, double labelled water (DLW) and GPS monitoring devices, (3) to determine the point prevalence of LEA using self-report instruments, DLW, dual-X-ray-absorptiometry (DXA) to quantify muscle and bone mass distribution and density, and a battery of hormonal analyses, and (4) to explore whether the prevalence of LEA varies across a full football season. Measures covering mental symptoms and psychological resources will be included, and a selection of biological measures derived from study 3.Measurements of DXA and DLW are resource-demanding and will be collected from one professional club (N~20 women). In contrast, the remaining data will be collected from four professional clubs (N~60 women) located in Bergen, the largest city within the Western region of Norway. Overall procedures and biobank storage procedures have been approved for data collection that will end in December 2024.

Corticocortical paired associative stimulation for treating motor dysfunction after stroke: study protocol for a randomised sham-controlled double-blind clinical trial

IntroductionStroke survivors can have a high disability rate with low quality of daily life, resulting in a heavy burden on family and society. Transcranial magnetic stimulation has been widely applied to brain injury repair, neurological disease treatment, cognition and emotion regulation and so on. However, there is still much to be desired in the theories of using these neuromodulation techniques to treat stroke-caused hemiplegia. It is generally recognised that synaptic plasticity is an important basis for functional repair after brain injury. This study protocol aims to examine the corticocortical paired associative stimulation (ccPAS) for inducing synaptic plasticity to rescue the paralysed after stroke.Methods and analysisThe current study is designed as a 14-week double-blind randomised sham-controlled clinical trial, composed of 2-week intervention and 12-week follow-up. For the study, 42 patients who had a stroke aged 40–70 will be recruited, who are randomly assigned either to the ccPAS intervention group, or to the control group at a 1:1 ratio, hence an equal number each. In the intervention group, ccPAS is practised in conjunction with the conventional rehabilitation treatment, and in the control group, the conventional rehabilitation treatment is administered with sham stimulation. A total of 10 interventions will be made, 5 times a week for 2 weeks. The same assessors are supposed to evaluate the participants’ motor function at four time points of the baseline (before 10 interventions), treatment ending (after 10 interventions), and two intervals of follow-up (1 and 3 months later, respectively). The Fugl-Meyer Assessment Upper Extremity is used for the primary outcomes. The secondary outcomes include changes in the assessment of Action Research Arm Test (ARAT), Modified Barthel Index (MBI), electroencephalogram (EEG) and functional MRI data. The adverse events are to be recorded throughout the study.Ethics and disseminationThis study was approved by the Medical Ethics Committee of Yueyang Hospital. All ethical work was performed in accordance with the Helsinki declaration. Written informed consent was obtained from all individual participants included in the study. Study findings will be disseminated in the printed media.Trial registration numberChinese Clinical Trial Registry: ChiCTR2000036685.