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    Default PCOS clinical trial UWS Campbelltown

    Hey All,
    My name is Lisa and i'm currently doing a clinical trial in women with polycystic ovary syndrome. the study is looking at whether it is feasible to deliver a 12 week weight training intervention (prescribed 2 sessions a week at the university plus 2 sessions at home) in improving health status (such as body changes, blood outcomes, questionnaires) women with PCOS and comparing this with an active control group receiving usual level of care (via gp's, clinicians, self- management). As it is the first study to look into weight training, this design will help to understand the effects this intervention may have in women with pcos and the main aims are to provide better guidelines that can better aid in the management of pcos given that the exercise recommendations are quite limited (it only states 150 minutes of exercise per week, and 90 should be of moderate-high intensity). If you would like any further information or have any queries your welcome to contact me. If you no not wish to be involved i would like to invite all women to join the facebook page to receive updates on the outcomes for the study. https://www.facebook.com/groups/1434032273498234/
    Best wishes
    Lisa Vizza

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    you must be recruiting only women with pcos or healthy women too as a control group

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    Hey Aisha, the trial will be recruiting only women with pcos. given that it is the first trial looking into weight training, it was important to compare this with usual care treatment that is given in pcos, so that we make several comments in terms of whether it was feasible to deliver weight training in pcos, but we also wish to make comments about usual care too, whether it is acceptable in women with pcos and whether more needs to be changed

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    Hi!

    I'm interested in hearing the results of your study when it is complete - please post a non-facebook link to the study once you are done.

    I've had PCOS for years and have managed it through diet and at least 1 hour of intense exercise, 6 days a week.
    How long are the weight training sessions and how intense are they?
    If a woman has a certain level of insulin resistance, 4 lots of exercise a week alone will not be enough to maintain their health. I'm interested in how you are controlling the variables with women's diets, meds, lifestyle/work (amount of usual activity).
    My other concern would be for the women of the group - I think they should be followed up post study because if they are not going to continue the exercise, the muscle they have gained is just going to turn to fat and not help their situation at all.

    All the best with your study x.
    Last edited by Little Ted; 16-03-2014 at 08:27.

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    Hey Little Ted,
    id be more than happy to post up results of the study once its completed. there is a facebook page but alternatively I could send those to you directly via email if that's more preferred
    first of all I would like to commend with what your doing to manage PCOS, that is really great, I know how tough it is given i also have PCOS and I admire your dedication to train that much , is your training mainly aerobics/weights or both? to answer your questions the supervised sessions (2x per week at the uni) will be 1 hr in duration and for each exercise (there will be 8-9 by memory) they will be training at neuromuscular fatigue (which will be between 8-12 rm) so id say the intensity would be from moderate-high intensity as it will be hypertrophy based training (there may be a slight increase in muscle mass but it wont be as much unless the trial was about 16 weeks or more). the home based (2x per week) will be body weight only (no weights) with 6 different exercises as ill need to factor in that some people may not have equipment at home. ideally we would of liked to include 3 supervised sessions a week but the difficulty would be it may be harder for women to commit to too many sessions given that they have other commitments which we need to be mindful of (such as work, family etc), so we thought that including the homebased sessions may provide a bit more flexibility. yeh absolutely I agree with you its a valid point and that may be something that we can comment on this trial. given that it is a feasibility trial there will be room for improvement , for example if we find that 2 heavy sessions and two unloaded (body sessions) weren't enough to cause any of the changes we were expecting we could report that it would be recommended to increase the frequency (amount of days to train) and/or intensity. for the diet aspect that isn't something that we aren't controlling, I will be asking questions about their overall diet and tracking for any changes after 12 weeks. I have found that in previous studies those that have done a restricted diet, im very happy to forward the studes if your interested there were bigger drop out rates as opposed to who got exercise alone, so that was our decision to not include a restrictive diet. medications/lifestyle and work related we will be asking these in the beginning,and every week we will be sending out a weekly status check to detect any changes in variables (such as medications, exercise, illness, injuries etc). to answer that second part that is a good point too and im very happy you raised that up. we are in the process of collaborating with colleague of mine who is an exercise physiologist (i am one too) and we are looking to offering a few alternatives, one may include include a follow up study to see if they are continuing with the intervention (as what you mentioned), another one may include providing special rate on gym memberships, or they can join chronic disease management classes where they are held weekly for 1 hour and they receive a personalised training program (which is mainly weights training with cardio). we are still in the process of finalizing this. I hope this answers your questions and I apologize for the very long post.

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    Thanks for your reply - it's great to find out more about what you're doing and I think it's a worthwhile study as there doesn't seem to be a lot of local research into PCOS and so many women like myself who are lead to believe (prior to dx) that they have problems maintaining their weight because they eat too much of the wrong foods and don't exercise enough!

    It will be interesting to see the follow-through results to see if the women are still continuing with the exercise post study. It is a shame that so many women drop out if diet is involved also but hopefully if they are exercising they won't want to undo their work by eating high-gi foods.

    Will they be getting their blood sugars tested too? - to ascertain level of insulin resistance. Just thinking that could be another variable. I know my levels can go up and down. Cortisol levels can also affect the body's ability to burn fat stores/energy.

    What will be your measurements for the study? Mass? Measurements? or more qualitative questions?

    Thank you,
    LT.

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    no worries at all yeh it would be interesting to see what the outcomes are given that there are lots of studies into diabetes looking into weight training, when you compare that with pcos theres not even 1, there are 3 studies that looked at aerobic plus resistance together although in these studies it is difficult to conclude what weight training does because the study designs make it tricky to determine this. my supervisor and i have an article in review (waiting for it to be accepted) in pcos about a rationale for weight training as the evidence based guidelines so i can send that through once it gets accepted. in my opinion i dont think theres a lot of awareness about pcos, there are some that know heaps about it (like endocrinologist, gynaecologist, doctors) and some that don't know much about it and dismiss patients that they need to go and lose weight or you cannot have children. i hear that a quite a lot while working with ladies that have pcos ladies and that is heartbreaking to hear and that needs to be changed. yeh id be keen on the follow up results too, because i hear a lot from women about not wanting to do weight training for the worry of bulking up or not knowing how to use the machines, i know thats a barrier for a lot of people so i hope that the trial serves as a purpose to educate women on correct technique so they can continue with these. yeh so in terms of the bloods, i had to be very mindful of the uni budget as you only get a certain amount per year. so for the blood tests this will all be done fasting early in the morning, which will include fasting glucose and insulin, testosterone, shbg, CRP (an inflammatory marker) and Hba1c. initially i really wanted to include oestradiol, LH and FSH as i was more interested in changes in menstrual cyclicity (as few studies have looked into this too) although these markers are cycle dependent, meaning they have to be done on day 2-5 of their cycle, and it would of been tricky to line people on those days as people can have either regular, irregular or none at all. other ones i was keen on looking at were more androgen markers (like androstenedione, DHEA-S), or others like prolactin (as high levels can affect menstrual cyclicity), , Anti-mullarian hormone levels(but they were quite expensive) cortisol seems an interesting one too and i was going to consider putting that one in too. As i was given the opportunity to use dexa for my study (full body scan measurement showing amount of lean tissue, fat %, bone mineral content) these were going to be 85-90 per scan so because i wanted to include this i had to be very selective on the blood test. ideally the more proper measurements that would be suitable to measure would be oral glucose tolerance test but i question if people who do this for the purpose of research. other measurements we will be looking into are the dexa which i mentioned before, waist/hip circumference, blood pressure, height/weight, and also questionnaires (including quality of life, anxiety/depression, exercise self-efficacy and perceived stress scale


 

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