SUBJECT INFORMATION SHEET

 Go back to Marathon Study page


Thank you for the interest that you have shown in our research study. Before you decide whether or not to volunteer to take part, it is important that you understand why the research is being carried out and what it will involve for you as a possible participant. Please take time to read the following information carefully and feel free to discuss it with others if you wish and contact us if there is anything that is not clear, or follow the links indicated for further details.

The British College of Osteopathic Medicine (BCOM) provides a 4 year Bachelor's degree and a 5 year programme leading to a Master's degree in osteopathic medicine in which students are taught the holistic approach to health, including diet and exercise, alongside osteopathic techniques. BCOM's commitment to cutting edge research into the benefits of this holistic approach is evident in its major investment in a state-of-the-art Research and Exercise Physiology lab, which is unique to osteopathic institutions in Europe.

What is the purpose of this study?

Physical activity is known to be beneficial to health and well-being, especially for the bones, heart and circulation. Although it is believed that exercise may be protective against osteoporosis (brittle bone disease), which is responsible for increased fracture rates in susceptible people as they get older, less is understood about the effects of prolonged intense exercise on bone structure and function. It is our intention to try to find out more about the processes involved in order to help to prevent fractures due to osteoporosis in later life. This is our second major study in marathon runners, conducted as part of our ongoing programme investigating ways of improving health and well-being through physical activity. The results of the first study from the 2004 marathon provided encouraging results regarding bone health and we are extending the time frame and the range of measurements over the training period through to after the race to encompass other inter-related elements of the body make up, including muscle strength and fitness, water balance and distribution, and body fat levels.

Why have I been asked to take part?

As an entrant in the London Marathon, your commitment to a sustained training schedule and the anticipated improvement in your fitness are essential elements of our study. We ask that you have not trained for or run a marathon before and that you are not currently undertaking any long distance running. We hope to carry out other studies in the future and if you are not eligible for this study due to previous running, we would still like to hear from you as we would take your contact details for the future. As there are a number of factors which affect bone health, we require that all subjects must not have taken thyroxine or corticosteroids during the past 6 months. There should also have been no previous foot or ankle fracture. For females only; no breast feeding in the last year; must not have experienced the menopause before 45 years of age; have not had ovaries removed and not received hormone replacement therapy.

Do I have to take part?

It is up to you to decide whether or not you wish to volunteer. If you do decide to take part we will make sure that you do fall within our criteria. You will then be given this information sheet to keep and will be asked to sign two consent forms; one for you and the other for our records. If you decide to participate but change your mind, you are still free to withdraw at any time and without giving any reason.

What will happen if I do take part?

If you agree to participate in this study we will post a screening questionnaire to find out your past and present general health and fitness to ensure your suitability to take part. If suitable you will be invited to attend a study day at BCOM on four different occasions (we will pay for your public transport to and from BCOM) each for approximately one hour; one before your training commences seriously (September/October '07), two during your training schedule (December '07 and March '08) and one after the London marathon (May '08). We ask that you keep a training log throughout September '07 to April '08 for which we will provide a booklet. We will attend on the race day itself to obtain some simple measurements upon its completion. In gratitude for your efforts we offer you three free massage sessions at BCOM with supervised senior osteopathic students, at a time of your choice during the study period and for up to one month after the marathon.

On the day of the appointment we ask that you do not have anything to eat or drink (except water) for a period of four hours before your appointment. BCOM will provide a snack meal in our canteen afterwards. When you arrive at BCOM, you will be able to ask us any questions and on your first visit will be asked to sign the consent forms.

After this, you will be asked to undertake a series of simple harmless measurements of your bone and body composition (essentially water, fat and protein):

1.     You will be asked to place the heel of each of your feet in an instrument called a 'Cubaclinical', which is used to assess your risk of bone fracture due to Osteoporosis and is done by passing ultrasound through the heel bone. The technique, which is similar to that used for scanning pregnant women, is safe and non-invasive and takes approximately 10 minutes to scan both feet. For this scan you will be required to remove tights / socks and to place one foot at a time into the machine. Gel is placed on the sides of the heel and transducer pads are brought in contact with the heel. Nothing is felt other than a slight pressure on the heel from the pads. If your result is significantly below that which we might expect from someone of your age and sex, we would, if you wish, send the information to your GP to follow up.

2.    You will be asked to lie on a couch while attached by electrodes to an instrument for bioelectrical impedance analysis (BIA), which will examine whether the distribution of extra-cellular and intra-cellular fluid in the limbs changes during training, the race and the recovery period. This quick and easy technique is used regularly at many gyms and by people in their own homes for measuring their body composition; the current used is so low that it cannot be felt and, as it is an alternating current, it is perfectly safe.

3.    You will be asked to sit in a chamber called the 'BodPod' for four separate measurements, of less than one minute each, whilst your body volume is measured using a technique known as air displacement plethysmography. This measure enables us to determine your body composition. You will need to wear a close fitting swimsuit, eg the lycra 'speedo' style not the baggier style (please bring one with you if possible), and a swim cap which we will supply. Inside the chamber you do not have to do anything apart from sit still and breathe normally. A large window enables you to see out clearly and you will also be in constant contact with the operator through a two-way microphone system.

4.    You will be asked to drink a small amount of water containing deuterium, which will increase only slightly the amount of deuterium than is naturally present in all the water that is in all of our bodies, so that we can assess your total body water. Deuterium is a safe non-radioactive isotope of hydrogen that occurs naturally in all our drinking water. We raise the baseline level by a minute amount, but to a level which we can measure. This procedure has been used in all age groups including newborn babies, children and pregnant women. You will provide an initial saliva sample before drinking this water and another sample four hours later. This second sample can be posted back to BCOM if necessary. We will pay the postage.

Importantly, we will use measurements of your total body water, body volume and body weight in combination in order to obtain more accurate assessments of body composition than are obtainable using most other methods.

5.    Various of your body dimensions will be measured. These so called anthropometric measures include: weight, height, arm and leg lengths and circumferences and skinfold thicknesses (we use skinfold callipers that compress the skin slightly but should not cause discomfort).

6.    You will be asked to complete a brief follow-up questionnaire.

7.    You will be asked to lie on a couch stabilised by belts around your pelvis and thigh and your foot will be strapped on to a footplate, which is part of the equipment called the Cybex. You will need to wear a cross trainer / mid-high or high top type shoe with a flat heel. Angled heels (common on running shoes) will not allow proper stabilisation. You will be asked to complete five repetitions of ankle flexion and extension, using your maximum strength. The Cybex will be used to measure the muscle strength and range of movement of your ankle joint.

During the race itself, we would like you to keep a note of your fluid intake.

What are the possible disadvantages and risks of taking part?

There are none known.

What are the benefits of taking part?

There is no intended health benefit for you in taking part, although the information we gather will be useful in the future helping us to decide what to recommend for health and well-being. However, you will find out information about your bones and whether you may be at risk of osteoporotic fracture, also the results will give you an indication of the proportion of your body fat in relation to your fat-free mass, which is made up of mostly muscle. Of general interest will be your muscle strength and joint range of movement, for which you can receive feedback on the results we obtain. Changes in all of these measurements due to training over the study period will be observed and communicated to you once we have completed the appropriate analytical procedures.

What if something goes wrong?

The following information is provided to support any individual who considers that they may have suffered damage through participating in the study. We believe that the likelihood of personal injury due to your taking part in the study is minimal. However, the protocol has also been reviewed by the research ethics committee of BCOM, consisting of a balance of external members, which has approved the study in the belief that it carries minimal risk to you as a volunteer and that it will provide beneficial information. However, research can carry unforeseen risks and we believe that is important that you are fully informed of your rights in the unlikely event of any harm occurring to you as a result of taking part in this study. All appropriate insurances are in place in the event of injury caused by a product defect from each manufacturer. In the unlikely event of injury due to negligence, claims may be pursued through legal action. General information on patient's rights, particularly as regards participation in research studies, may also be obtained from your local Community Health Council.

Will my data be kept confidential?

Your confidentiality will be protected, both in terms of your personal involvement and your particular data from the study. Any forms that we have regarding your name and address will be kept in a separate place from your research details and will be locked away. Your name will not be associated with any of your data that will be used for subsequent analysis.

Will expenses be covered?

We will cover the cost of public transport to and from BCOM on each of the 4 occasions for taking measurements. If you wish we can provide a small sandwich snack from our canteen.

What will happen to the results of this research study?

It will take a while before the overall results of this study are analysed. Although your personal results will be available shortly after the individual tests and will be posted to you, some results may take a little longer to process due to the nature of the analyses. Specifically, where results of the Cubaclinical scan are low, i.e. there may be an increased risk of bone fracture, with your consent, results can be forwarded to your GP. Once we have collected and analysed all our data, we intend to write up and publish our findings in an appropriate scientific journal. You will also be able to receive these overall study findings if you wish.

Who is organizing and funding this study?

BCOM is funding the study. The researchers are mainly from BCOM but with other experts in the field from the Institute of Child Health. The researchers do not gain any special payments or reward for conducting the study or for including you in it.

Who has reviewed the study?

BCOMs research ethics committee, which has external members from the medical and legal professions and lay members, has reviewed all aspects of this study and granted approval for it to go ahead within the terms specified.

If you would like further information, please contact:

Dr Heather J Hinkley at BCOM:Tel, 020 7435 6464 ext 342; E-mail,

hh@BCOM.ac.uk, or Mrs Daphne Bird ex 341

Thank you for reading this information sheet. We look forward to meeting you and wish you all the best for your training and for the race itself