Claire Pentecost

Gender differences in growth hormone response to exercise before and after rhGH administration and the effect of rhGH on the hormone profile of fit normal adults

Objectives  Exercise is a potent physiological stimulus of GH secretion. We hypothesized that exogenous recombinant human growth hormone (rhGH) administration through an increase in GH and IGF‐I levels would blunt the GH response to exercise. The aim of the study was to examine and compare the impact of rhGH on the exercise‐induced GH response in healthy normal men and women.

Endocrine profiles in 693 elite athletes in the postcompetition setting

To measure a profile of hormones in a group of elite athletes. Increasing awareness of the widespread use of hormones as performance‐enhancing agents focusses attention on what may be considered as normal in this unusual group.

Effect of 6-month supervised exercise on low-density lipoprotein apolipoprotein B kinetics in patients with type 2 diabetes mellitus

Although low-density lipoprotein (LDL) cholesterol is often normal in patients with type 2 diabetes mellitus, there is evidence for a reduced fractional catabolic rate and consequently an increased mean residence time (MRT), which can increase atherogenic risk. The dyslipidemia and insulin resistance of type 2 diabetes mellitus can be improved by aerobic exercise, but effects on LDL kinetics are unknown. The effect of 6-month supervised exercise on LDL apolipoprotein B kinetics was studied in a group of 17 patients with type 2 diabetes mellitus (mean age, 56.8 years; range, 38-68 years). Patients were randomized into a supervised group, who had a weekly training session, and an unsupervised group. LDL kinetics were measured with an infusion of 1-(13)C leucine at baseline in all groups and after 6 months of exercise in the patients. Eight body mass index-matched nondiabetic controls (mean age, 50.3 years; range, 40-67 years) were also studied at baseline only. At baseline, LDL MRT was significantly longer in the diabetic patients, whereas LDL production rate and fractional clearance rates were significantly lower than in controls. Percentage of glycated hemoglobin A(1c), body mass index, insulin sensitivity measured by the homeostasis model assessment, and very low-density lipoprotein triglyceride decreased (P < .02) in the supervised group, with no change in the unsupervised group. After 6 months, LDL cholesterol did not change in either the supervised or unsupervised group; but there was a significant change in LDL MRT between groups (P < .05) that correlated positively with very low-density lipoprotein triglyceride (r = 0.51, P < .04) and negatively with maximal oxygen uptake, a measure of fitness (r = -0.51, P = .035), in all patients. The LDL production and clearance rates did not change in either group. This study suggests that a supervised exercise program can reduce deleterious changes in LDL MRT.

Combining behavioural activation with physical activity promotion for adults with depression: findings of a parallel-group pilot randomised controlled trial (BAcPAc).

BackgroundDepression is associated with physical inactivity, which may mediate the relationship between depression and a range of chronic physical health conditions. However, few interventions have combined a psychological intervention for depression with behaviour change techniques, such as behavioural activation (BA), to promote increased physical activity.MethodsTo determine procedural and clinical uncertainties to inform a definitive randomised controlled trial (RCT), a pilot parallel-group RCT was undertaken within two Improving Access to Psychological Therapies (IAPT) services in South West England. We aimed to recruit 80 adults with depression and randomise them to a supported, written self-help programme based on either BA or BA plus physical activity promotion (BAcPAc). Data were collected at baseline and 4 months post-randomisation to evaluate trial retention, intervention uptake and variance in outcomes to inform a sample size calculation. Qualitative data were collected from participants and psychological wellbeing practitioners (PWPs) to assess the acceptability and feasibility of the trial methods and the intervention. Routine data were collected to evaluate resource use and cost.ResultsSixty people with depression were recruited, and a 73 % follow-up rate was achieved. Accelerometer physical activity data were collected for 64 % of those followed. Twenty participants (33 %) attended at least one treatment appointment. Interview data were analysed for 15 participants and 9 study PWPs. The study highlighted the challenges of conducting an RCT within existing IAPT services with high staff turnover and absences, participant scheduling issues, PWP and participant preferences for cognitive focussed treatment, and deviations from BA delivery protocols. The BAcPAc intervention was generally acceptable to patients and PWPs.ConclusionsAlthough recruitment procedures and data collection were challenging, participants generally engaged with the BAcPAc self-help booklets and reported willingness to increase their physical activity. A number of feasibility issues were identified, in particular the under-use of BA as a treatment for depression, the difficulty that PWPs had in adapting their existing procedures for study purposes and the instability of the IAPT PWP workforce. These problems would need to be better understood and resolved before proceeding to a full-scale RCT.Trial registrationISRCTN74390532. Registered on 26 March 2013.

Amalgamation of Marginal Gains (AMG) as a potential system to deliver high quality fundamental nursing care: a qualitative analysis of interviews from high performance AMG sports and healthcare practitioners

AIMS AND OBJECTIVES To investigate the components of the Amalgamation of Marginal Gains (AMG) performance system to identify a set of principles that can be built into an innovative fundamental nursing care protocol. BACKGROUND Nursing is urged to refocus on its fundamental care activities, but little evidence exists to guide practising nurses. Fundamental care is a combination of many small behaviours aimed at meeting a persons care needs. AMG is a successful system of performance management that focusses on small (or marginal) gains, and might provide a new delivery framework for fundamental nursing care. DESIGN Qualitative interview study. METHODS We undertook in-depth interviews with healthcare and sports professionals experienced in AMG. We analysed data using open coding in a framework analysis, and then interrogated the data using Normalisation Process Theory (NPT). We triangulated findings with AMG literature to develop an intervention logic model. RESULTS We interviewed 20 AMG practitioners. AMG processes were as follows: focusing on many details to optimise performance, identification of marginal gains using different sources, understanding current versus optimum performance, monitoring at micro and macro level and strong leadership. Elements of normalisation were as follows: whole team belief in AMG to improve performance, a collective desire for excellence using evidence-based actions, whole team engagement to identify choose and implement changes, and individual and group responsibility for monitoring performance. CONCLUSIONS We have elicited the processes described by AMG innovators in health care and sport and have mapped the normalisation potential and work required to embed such a system into nursing practice. RELEVANCE TO CLINICAL PRACTICE The development of our logic model based on AMG and NPT may provide a practical framework for improving fundamental nursing care and is ripe for further development and testing in clinical trials.

Intervention development and treatment success in randomised controlled trials of rehabilitation

Citation for published version (APA): Rogers, A., Mackenzie, I., Rorie, D., & MacDonald, T. (2017). Successful recruitment to a large online randomised trial: the TIME study. In Trials: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials (Supplement 1 ed., Vol. 18, pp. 222-223). [089] (Trials; Vol. 18, No. Suppl. 1). United Kingdom: BioMed Central. https://doi.org/10.1186/s13063-017-1902-yThe study will address variability in practice, defined in Standard Operating Procedures, that UK Clinical Trials Units (CTU) have in place for: i) defining, ii) classifying, and iii) reporting adverse events in non-CTIMPs. Compared to drug trials, adverse events in non-CTIMPs are not managed well. There is considerable inconsistency in reporting styles between trials of similar design and intervention type. To promote increased consistency, we will conduct a consensus exercise among non-CTIMP experts using a Delphi technique followed by a face-to-face meeting. This method adheres to the recommended sequence outlined by the international network for Enhancing the Quality and Transparency of Health Research (EQUATOR) for developing health research guidelines. A non-CTIMP expert is defined as: a CTU representative, a Chief Investigator or trial manager of non-CTIMPs with >3 trials experience in this role, or a senior member of the Health Research Authority’s Operations team or Ethics Committee. As such, the participants in the consensus exercises will also be the direct beneficiaries from the project maximising its pathway to impact. Following the face-to-face meeting — guidance and explanatory statements will be drafted. The guidance statement will focus on: • how adverse events should be defined in relation to the non-pharmacological intervention, • how CTU standard operating procedures should be designed to reflect the results of the Delphi exercise, • how adverse events should be classified following a judicious causal assessment, and • recommended reporting methods that will promote more effective meta-analyses of non-pharmacological interventions that provide a balanced benefit-harm evaluation. Following study completion, we will work with a selection of UK CTUs to evaluate the implementation of any agreed modifications to current practice.This is the final version of the article. Available from BioMed Central via the DOI in this record.Objective Multi-centre RCT designs provide robust evidence of therapeutic effect of health interventions. However participating centres often differ in how well they conduct the trial and the number of patients successfully recruited. This paper describes barriers different research teams encountered when conducting a complex RCT comparing a surgical procedure with physiotherapy, and the actions taken by the trial management group to overcome obstacles that were hindering recruitment. Methods We conducted 22 interviews with principal investigators and research associates at 14 sites involved in the delivery of a surgical RCT that compared hip arthroscopy and physiotherapy for hip pain. Interview transcripts were analysed thematically and case study approaches were utilised to present results to the trial management group. Results Research teams reported difficulties related to logistics (e.g. Room space); motivation (e.g. PI reluctant to approach patients); and skill (e.g. Lack of knowledge about the treatment arms). Similar Issues were shared by sites that recruited to target and those that did not, however there were differences in the team ’ s response to challenges. Whilst on-target sites found local solutions to issues or support through their research infrastructure or the trial TMG, off-target sites usually did not show proactivity. Site profiles were created and action plans designed based on aspects that were particular to the individual sites. These plans were implemented in collaboration with site teams. Conclusions This qualitative study added to the growing evidence of how aspects of team functioning are important for recruitment to complex RCTs. Trial Management Groups can help research teams identify and ad- dress issues, and therefore contributing to a sense of ownership by the research team. Empowering research teams to find solutions at local level is essential to conduct multi-centre RCTs successfully.