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Found 3 Actively Recruiting clinical trials
RECRUITING
Healthy Volunteer
Nutritional strategies, including supplementation, are widely sought after to improve the function of the neuromuscular system (muscle strength and power). Milk fat globule membrane (MFGM, composed of the membrane that surrounds milk fat droplets) has begun to receive increasing attention as a potential supplement to improve muscle function and size due to a series of promising longitudinal studies (\> 4 weeks of supplementation), however the overall findings are still conflicting which is likely due to methodological limitations of previous studies. Therefore, it is important to thoroughly investigate whether chronic supplementation of a MFGM-containing supplement is effective at improving the function and physiology of the neuromuscular system within healthy, recreationally active adults. This study aims to compare the effects of chronic (12 weeks) bioactive whey protein concentrate (BWPC) supplementation versus an isocaloric, isonitrogenous whey protein isolate placebo on the physiology (contractile properties, coactivation, timing of action potentials), morphology (total/functional muscle cross-sectional area/volume), and function of the neuromuscular system of healthy, recreationally active adults. Utilising a randomised, double-blind, parallel group study design, participants will be allocated to one of two groups: BWPC or placebo supplement group. Once consented, participants will complete screening questionnaires to confirm their eligibility. Altogether, participants will be required to attend 5 laboratory sessions (1 familiarisation \~ 1.5 hours, 4 main measurement sessions each \~ 2 hours) at the neuromuscular laboratories situated within the Matthew Arnold building at Loughborough University. The familiarisation and first two baseline measurement sessions will be done over a 2-week period, after which participants will be asked to consume a supplement daily for 12 weeks (84 daily doses) while they maintain their usual lifestyle (diet and exercise/physical activity). Then they will attend two further post measurement sessions, with the first being at exactly 12 weeks of supplementation (i.e. 84th day) and the second being 3-4 days later (i.e. 87th or 88th day). The supplementation protocol will involve participants mixing 1 scoop of supplement with water and consuming the resultant drink alongside their breakfast. Participants will be required to fill in a diet record form twice across the supplementation period (week 3 and 9), which involves weighing and recording what they eat/drink over 3 consecutive days. Physical activity at pre and post will be assessed through the International Physical Activity Questionnaire (IPAQ, short format). During the familiarisation session participants will get to try all of the types of contractions (voluntary and involuntary) to be performed in the main measurement sessions, but without the recording of electromyography (EMG). The first measurement session at baseline/post will begin with countermovement jumps on a force plate. The remainder of the session will involve various isometric knee extension or flexion contractions within a custom-built isometric dynamometer. This will include maximal and explosive voluntary contractions to assess maximal strength of the knee extensors and flexors and rate of force development of the knee extensors, respectively. Supramaximal femoral nerve stimulation will be utilised to evoke twitch contractions of the knee extensors. Submaximal transcutaneous muscle stimulation will be performed to assess the force-frequency relationship (1 - 100 Hz) of the knee extensors. Finally, submaximal knee extension contractions (10 and 25% of maximal voluntary force) will be performed while a concentric needle electrode is inserted into the vastus lateralis to assess the stability of neuromuscular junction transmission. Throughout this measurement session, surface EMG signals will be collected by placing surface EMG electrodes on each of the 3 superficial quadriceps muscles (rectus femoris, vastus lateralis and medialis) and on the hamstrings (medial and lateral). Within the second measurement session at pre/post, participant's will have an 3.0 T MRI scan of the lower limbs. The procedure will be clearly explained to the participant before they sign the MRI agreement form and fill in the MRI safety questionnaire. For this study we want to assess whether any potential benefits of milk fat globule membrane are influenced by age. Therefore, we will be recruiting 2 subgroups (young 18 - 30 years old; older 60 - 75 years old). The power analysis was based on detecting a group by time interaction for isometric strength, with input parameters of: effect size = 0.15, alpha = 0.05, power = 0.8, correlation among repeated measures = 0.8. Altogether, 38 participants are needed as a minimum within each age group (19 per group). However, to account for a 25% drop-out rate, 48 participants will be recruited for each age group. The total number of participants recruited will be 96 (48 young, 48 older). Statistical analysis will involve fitting linear mixed effect models to detect any main effects or interactions, with supplement group, time (pre vs post), and their interaction as fixed effects, and participant as a random intercept. Visual plots (histograms and quantile-quantile plots) will be used to verify the assumptions of normality, linearity, and homoscedasticity of residuals.
RECRUITING
Healthy Volunteer
Over 200,000 people in the UK have axial spondyloarthritis. In 80% of cases the condition begins in the second or third decade of life. Exercise is encouraged as an essential treatment of axial spondyloarthritis (axSpA), with the potential to both promote well-being, increase flexibility and range of movement, improve posture and reduce stiffness and pain. axSpA is an inflammatory arthritis and raised levels of indicators ('markers') of this inflammatory process (e.g. CRP) can be detected in the blood of patients. These markers are released as a consequence of the condition, but some, such as TNF-alpha and interleukin-17 (IL-17), also promote further disease development. In other inflamed patient groups we have shown that regular exercise (brisk walking) can lower the levels of these pro-inflammatory markers in the blood and increase levels of anti-inflammatory markers, independently of weight loss. Despite axSpA being an inflammatory condition with prescribed medication focused on reducing inflammation there are no studies that have assessed the potential of exercise to act as an anti-inflammatory adjuvant to biologic therapy in axSpA. This research will investigate the effect of 12 weeks of a home-based walking exercise intervention on measures of systemic inflammation and body composition, well-being and measures of disease activity using established and validated methods in 20 axSpA patients on regular biologic therapy and compare this group with 20 patients on regular biologic therapy who carry on with their standard care and normal levels of activity. Also, a baseline comparison will be conducted between a group of 20 healthy individuals and axSpA patients (40).This proof-of-concept study will determine the potential of exercise as an adjuvant anti-inflammatory treatment for patients with axSpA taking biologic medication.
RECRUITING
Pain can be one of the primary limiting factors to progress following musculoskeletal injury and may be caused by trauma or degenerative changes. There are few exercise rehabilitation interventions able to relieve pain, thereby reducing the number of military personnel fit for operations. Low load blood flow restriction (BFR) exercise has been shown to elicit an analgesic response and promote beneficial physiological changes in a variety of clinical populations. This two phase study, aims to: * Determine the most effective and feasible BFR resistance exercise protocol for reducing pain in UK military patients. * Determine the efficacy of an optimal BFR exercise protocol for reducing pain and improving rehabilitation outcomes in UK military patients. * Identify key physiological mechanisms underpinning any beneficial effect of BFR exercise on pain. Consequently, results from this study will have direct clinical application and will aid best practice guidelines for the management of pain across Defence Rehabilitation by influencing the future rehabilitation paradigm. The investigators believe the results and impact will be far reaching, providing invaluable insight and knowledge to the clinical and scientific community to not only those embedded within Defence Rehabilitation, but also those working in civilian sector organisations and professional sport also.