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Kennedy's Disease Chat Transcript   07-16-2011

Topic:  NIH Clinical Trial on Exercise

Guest:  Dr. Chris Grunseich, NIH

Host: Mike Goynes

MikeG
Hi Chris!
Moseremous
Hi mike
MikeG
and a good Sunday morning to ya
Moseremous
thought i was too early
MikeG
yep I got on early to see if the past buffer is going to work in IE
MikeG
we've got about 20 mins
Moseremous
oh okay
MikeG
and, like Firefox, Safari, and Chrome - it doesn't work... :(
Moseremous
thought it started midnight my time
MikeG
so how's the weather over there now?
Moseremous
finally some rain after four weeks of cold weather
Moseremous
cold here means 15 degrees celius
Moseremous
celcius
MikeG
how far are you from Melbourne?
Moseremous
are you in melbourne?
MikeG
no, but I will be in early December
Moseremous
oh yes,
MikeG
remember?
MikeG
then Perth...
Moseremous
i am about three hours north of melbourne by plane
MikeG
and we're still debating Brisbane I Sydney
MikeG
may be too hot in December
Moseremous
if you don't have four weeks to spare i would probably only do melb, perth and maybe a quick stopover in sydney
MikeG
yeah, that's what we're thinking
Moseremous
we'd lovce to see you in brisbane, but with perth in the equation it sort of discounts brisbane
MikeG
wow - 15 degrees is no fun on the hands
Moseremous
red wine keeps them warm
Moseremous
haha
MikeG
lol
MikeG
do you know Mike White?
Moseremous
i have emailed him a few times back and forth since the last chat
Moseremous
seems a great guy
MikeG
yes, he is!  Maybe you and Cliff and Mike could get the KD - Down Under going...
MikeG
do you know how to do a web page?
Moseremous
trouble is distance, although with computers thats not really an excuse
Moseremous
my brother runs a web hosting business, netports
Moseremous
he could set something up
MikeG
yeah, no one here actually eyeballs anyone unless they live in the same city like Don & I
MikeG
that would be great!
Moseremous
mike white said he went to the last conference abd had a great time
MikeG
we do everything in Joomla and we can add the AU to ours and give you a complete site that you could modify as you pleased.  FREE!
Moseremous
but it would be just a copy of your site, we realy have nothing here to add, no research etc. although i guess just contact details would be good
MikeG
sure - you coulod like to ours for the research, chat room, etc...
MikeG
link
Moseremous
you wouldn't beleive how the kda site has helped me over the past 15 years
MikeG
I know - me too!
Moseremous
the doctors here have no idea, and i take transcrips of research info etc to my gp
Moseremous
general practicitioner
MikeG
funny thing, in 1995 the only resource was the MDA in Austraila!
MikeG
I posted on their site and Terry found my post and got in touch - I was the only one at the time that he knew of that had KD...
Moseremous
in 1993 when i was disagnosed they said all female offspirngs should be terminated. thank god i had just had my second daughter
Moseremous
they rea;y had no idea
MikeG
then he found Pat Griffith and the web site was born
Moseremous
amazing how it has grown
MikeG
Terry and Susanne have done so much good by starting it - there is no telling how many people they have helped!!!
billeric
good morning guys
MikeG
were you diagnosed with the genetic blood test Chris?
TedA
Hello from Richmond, VA
MikeG
Ted, have you done any sailing up there yet?
Moseremous
yes mike
MikeG
GREAT!
Moseremous
in 1993 they had to send samples to us
Moseremous
an i waited three months for results
MikeG
ok, in 1990 I had to send samples to Duke...
Gary_KC
Good morning. This is Gary joining in from Kansas City. It is already over 80 degrees this morning. It is hot! My PC broke down. So I could not join the chats for a while.
MikeG
same here
Stan
Good morning all from Michigan
Moseremous
hi garry send some warth down under
Moseremous
warmth
MikeG
glad to see you back Gary
Bruce
Gary, and here I thought you just didn't like us any more.:)
Moseremous
hi bruce
TedA
No I had to go to CA a couple of times to sail.    In late August I will be in Canada for 5 days of racing
Bruce
TedA, where will you be racing in Canada?
MikeG
that's good Ted, have you done any on the lakes up in VA?
TedA
Hamilton Ontario
Bruce
Morning Chris, thanks for joining us this morning
chrisgrun
Good morning everyone. Excited to discuss with everyone.
MikeG
Morning Dr Chris
chrisgrun
Chris is fine.
MikeG
yes, we are all anxious to hear about the trial
chrisgrun
We are excited to have new participants.
chrisgrun
The study is looking at the effect of exercise on strength in kennedy's disease.
memo

MikeG
how many are n the pot so far?
chrisgrun
one so far. but we have many lined up.
chrisgrun
we hope to recruit a total of 50.
MikeG
I called and signed up but never heard back from anyone.
chrisgrun
Angela has all of your information Mike, she will contact you shortly and schedule you.
stewart
Good morning
MikeG
I called and signed up but never heard back from anyone...
MikeG
ok,
chrisgrun
Right now we have about 10 new patients scheduled
MikeG
IE is messing with me - I should have stuck to Firefox
chrisgrun
Once participants come to the NIH they will be randomized to one of two arms of the study-- two different forms of exercise
MikeG
So the trial will be a placebo exercise and the real thing but we won't know which one we have - right?
chrisgrun
that's right , but it is not a real placebo because there is the possibility that the control arm will have more benefit than the intervention arm.
chrisgrun
you will probably be able to figure out which arm of the study you were assigned to.
chrisgrun
that 's why it is not a double blinded study, but a single blinded study (only the evaluators are blinded)
Moseremous
chris, prior to the study is ther a current thinking about the benefits or otherwise of exercise
MikeG
interesting
chrisgrun
Yes, there is concern that aerobic exercise can lead to bad effects in terms of weakness as was shown by the study in Denmark several years ago.
chrisgrun
We will study a different form of exercise- designed by our rehab dept. who has experience seeing many guys with KD.
Moseremous
so you are examining this with your study?
Moseremous
oh okay
MikeG
good, I'm safe... I couldn't do aerobic exercise if I had to!
Moseremous
haha
chrisgrun
we will be looking at many different types of outcome measures- some related to balance performance, stress, depression..
chrisgrun
exercise can have many different effects on the body, but exactly how it will effect muscle strength in KD is not well defined yet.
chrisgrun
There is growing evidence that the muscle itself may be playing a role in the disease- that's why it is important that we look into this.
chrisgrun
we will also be using accelerometer devices that the subjects will wear on their hips for the initial and final 10 days of the trial to record the rough "total" of physical activity.
chrisgrun
We are very excited about the trial- and hoping that you will be able to participate.
MikeG
Chris, what are the pre-requisites for the trial?
chrisgrun
The NIH will provide for your lodging and transportation from any location in the US.
chrisgrun
There are several- be able to walk a distance of 50 feet with or without a walker,  able to stand for 10 minutes without the use of an assistive device, access to a computer with internet connection, age greater than 18, no other medical condition that would prevent exercise such as heart disease, lung disease, not beginning a separate exercise program within the two months prior to starting our trial.
chrisgrun
We also be test your AMAT (adult myositis assessment tool test), and if you are too strong or too weak, we may ask you not to participate.
Stan
So, even though I can walk further and do more than what is required, I'm out because I have a pacemaker and COPD?
MikeG
for the "able to stand for 10 minutes" - can we just touch a wall with our finger?  I need the feedback to be able to do that.
chrisgrun
Hi Stan, not necessarily-- why don't you speak with Angela over the phone and we can find out exactly what you can and can not do.
chrisgrun
Hi Mike- this should be fine. you can use your finger.. but we would prefer not using a cane for instance.
MikeG
I can do that!
MikeG
how many participants will be in the trial?
chrisgrun
Good, I think that it would be best to discuss your health with Angela so that she can ask specific questions that would be helpful in knowing.
stewart
What about medications, would Avodart for example exclude you?
chrisgrun
There will probably be about 80 subjects who are screened- and we anticipate that 20% will not meet the inclusion criteria,, then an additional 20% might drop out of the study. So we would have a final number of 50 in the trial.
chrisgrun
No, you can take Avodart. That is fine. We wouldn't want the participants to take a medication that might make them tired while they are performing the exercises..Like sedatives.
Moseremous
chris, when i was diagosed in 1993 and still playing competition tennis, my first reaction was to hit the gym and biuld up like arnorld swazenegger, but i was told that the less i use the mussles the longer they would last. 18 years later i am still walking okay but now have heart problems due to lack of exercise. This study appears to be the the perfect answer. do we exercise or not
chrisgrun
yes, it is a good question that needs to be answered. We will also be collecting history information from all of the subjects to get information on everyone's prior experience with exercise so that we know what may have worked for some subjects and not others. It is helpful to have everyone's experiences organized into one database.
stewart
What time frame are you looking at, when is the planned start date etc.
chrisgrun
we will also be collecting information on prior work habits and how that may have influenced your outcomes with weakness.
chrisgrun
We started the trial last week, and we will be recruiting about one new subject per week. The subjects will be in the study for a total of 16 weeks- 12 weeks of exercise and then a 4 week followup period. You would come to the NIH at the beginning and then 12 weeks later.
chrisgrun
If you are interested in coming in, please contact Angela Kokkinis at 301-451-8146  or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.
chrisgrun
The study will likely take a year and a half to finish if everything goes well.
chrisgrun
There will also be significant followup during the 12 weeks of exercise with telephone contacts and video taping to make sure that there are no problems with the exercises.
MikeG
how soon after it's complete do you think you will have the results?
chrisgrun
It won't take too long-- our statisticians will have to crunch the numbers. It should take just one to two months to know whether or not it was beneficial.
chrisgrun
There are some lab studies that we are also doing looking at how the hormones will change with the exercise- testosterone and IGF-1 (insulin like growth factor 1)...
Moseremous
sounds like a great study, i hope all you guys in the u.s. get into it
chrisgrun
We would like to know if the exercise has any effect on these hormones,, or if the hormone levels will predict someone's response to the exercise.
Stan
Will we have to give up any of our normal activities while on the study? I have a few trees that i have to cut up from the storms, etc.
chrisgrun
We would also be delighted to have individuals from outside the US participate. If you can get to the US, then the NIH can pay for your transportation here and your lodging in Bethesda, MD for the study evaluations.
Moseremous
hey chris if you will pay airfare from australia i would love to. haha
chrisgrun
No, you will not have to give up any other activities,, as long as you don't start a new exercise program that involves at least two weekly sessions of 20 minutes of exercise in each session. You should be able to do the yard work with no problem.
Moseremous
no excuse to leave the trees hehe
chrisgrun
Well, Maybe I can convince Kurt Fischbeck to fly me to Australia and then we can bring the exercise study to you..
MikeG
:)
Moseremous
yeah, i will meet you on the great barrier reef
MikeG
I'll help you Chris...
Stan
Ok. I ask because the yard work is exercise and taxes the muscles. It can be quite strenuous.
chrisgrun
Sure, I'm up for that.
MikeG
we're going in December - will that work for you?
Moseremous
stan, get someone into do it and you supervise
chrisgrun
The yard work should be OK.  I think that the supervision also sounds like a good idea.
chrisgrun
Yes, we will be having new subjects come in during december. If you haven't heard from Angela recently, you will soon and she'll let you know about a date. We will accomodate you.
Stan
Nobody around to help usually. Couldn't do it if the wife was around to supervise. : )
Moseremous
haha
chrisgrun
good to be safe with this, especially if you're on a ladder..
MikeG
hi Terry
TerryW
Hello
chrisgrun
Good morning
Stan
Ladders and table saws are on my list of no-no's.
MikeG
I don't do ladders...
stewart
Great, I'm ready. I'll contact Angela next week. How long would I need to stay in Bethesda if selected. Thanks
Moseremous
i don't do stairs
chrisgrun
THat's good, your stability is something that can be affected in KD, we will be measuring stability also during the study.
TerryW
I have a question for you all,  Does anyone here suffer from "Severe morning depression"
MikeG
me either... I'm lucky to be walking at 63!
chrisgrun
You would stay at the NIH overnight the first night, then for two days (total of three days here)>
MikeG
no Terry - not me.
Stan
Not here, Terry.
Bruce
Nope, Terry
Moseremous
no terry, if i wake up, its a good day. Maybe your mediation
Moseremous
medicqation
Moseremous
medication
Gary_KC
not for me, terry
Moseremous
i'll get it right
MikeG
three days at the end of the trial too?
TerryW
"severe moening depression happens when you first wake up you have feelings that you wish you have died in your sleep, feelings of suicide,  overwhelming emotions.
chrisgrun
Depression is something that Angela is interested in looking at with this study-- potentially if there is an interaction with exercise. And also how many individuals with KD have this problem..
TerryW
I have had this for the past few months where I wake up in tears and uncontrolled emotions
TerryW
as the day goes on it goes away
billeric
No Terry
chrisgrun
THis is somthing that you should speak to your internist about. they should be able to help you.
TerryW
I read about it and they say it is emotions that you build up overnight in your consious and when you wake they release.
Stan
Sorry, Terry. Haven't experienced that. I hope it's not something to look forward to.
MikeG
yep - sounds like you need to look into what meds you're taking... or should take.
TerryW
sub consious
TerryW
I take no meds
chrisgrun
it is a serious problem.. but one that can be helped for sure.
Moseremous
hey terry when you wake up, think of me, a guy you have never met but someone who you have helped more than you can ever imagine
TerryW
:)
Moseremous
you and angela have kept me going for years
chrisgrun
Sometimes that quality of your sleep can also effect your mood the next day.. You might not be sleeping effectively, and might need a sleep study to better evaluate this.
chrisgrun
Good thing to discuss with your neurologist
TerryW
I need to go I think,
chrisgrun
Yes, Mike-- same three days at the end of the study also.
Tomk
will the a Partial report on the study be discussed at the November KDA meeting??
MikeG
good.  And our nights are free except for the first?
chrisgrun
Depression is a serious problem for which there can be many causes-- it's important to get a full medical evaluation to see what could be causing it, then to come up with an appropriate way in which it can be managed..
Moseremous
something to take seriously terry..talk with your doctoer
chrisgrun
Yes, we'll discuss it at the November meeting..
chrisgrun
The entire stay at the NIH will be payed for. We'll pay for sunday night when you get here.. then for the duration of your stay in Bethesda for the study.
TerryW
I will probably have to talk with him about this.  I have been holding off because I have always been able to handle it, but I can't anymore
chrisgrun
Excited to present more details at the november meeting- we should have some data by then.
MikeG
do it Terry!
chrisgrun
Yes, definitely.. They will be able to have a plan. It is a common problem that can happen to anyone, and it is important that it is handled the right way.
MikeG
Great - we're looking forward to it!
billeric
You have helped too many people not to help yourself Terry.
TerryW
SOrry that I have not been as active in the past few months chats,
TerryW
Thanks bill
Bruce
Chris, this is exciting stuff.  I have been an advocate of smart-exercises for many years.  It will be great to see the results.
Stan
Hey Terry, we all have lives. We can't make all the chats.
MikeG
Chris thank you so much for sharing this information with us.  I'm sure there will be a good number of participants to choose from.  We all look forward to it!
TerryW

chrisgrun
The NIH is excited to have the KDA involved in this study, and also in future studies.. There will likely be some drug studies coming up in the next few years.. We are waiting for some additional data with animal studies, but have some promising leads.
Bruce
Does IGF-1 still show some promise?
chrisgrun
We are also making stem cells from the KDA subjects that we saw at the NIH- and are currently making motor neurons and other cells from them to better understand the disease.
MikeG
wow!
Bruce
Thanks, Chris, for joining us today.  We appreciate all that your team is doing.
chrisgrun
The IGF-1 has shown good promise with the animal studies.. Carlo Rinaldi has done the animal work here in our lab to inject a form of IGF-1 into mice with KD-- the mice have a trend towards increase survival-- and there are dramatic improvements in the muscle-- decreased atrophy and degeneration.
TerryW
Sorry, my PC shut down right in the middle of chat
Bruce
That and ASC-J9 are too of my hopes.
Bruce
two
MikeG
me too!
chrisgrun
We are also measuring the IGF-1 levels again in the KD subjects for the study.. Based on stored serum from KD subjects from the previous studies, the IGF-1 levels were found to be low. We would like to repeat that measurement now to see if it holds up..
chrisgrun
We hope to use the animal models and cell culture systems to help us screen through these drugs to find the ones which have the best potential to work.
TerryW

Bruce
We probably need an update on the IGF-1 research since it has been about a year or more since Maria was on the chat to explain it.  It still sounds likeit has promise.
Bruce
Thanks again Chris.  We appreciate you taking the time to be on our chat this morning.
chrisgrun
Yes, it has promise.. Now that we know that an injectable form of the drug also works in animals.
Gary_KC
Chris, thank you very much for your time sharing the information with us.
MikeG
Thanks again for joining us today Chris.  We all look forward to a successful trial!
Moseremous
thank you very much chris
TedA
Thanks Chris!
stewart
Thankyou, You guys help me so much, I find having the disease to be such an emotional roller coaster before KDA I was alone with it. Thanks
billeric
Thanks Chris
chrisgrun
Thanks everyone. I will get going now. Have a great day, and look forward to seeing everyone in November.
Stan
Thanks. Looking forward to any updates.
chrisgrun
thanks again. Hope to see you in Bethesda for the trial.