Faculty of Health and Wellbeing Research Ethics Committee
Sport and Exercise Research Ethics Review Group

Participant Information Sheet

Effects of 2 weeks of “practical” low-volume high-intensity interval training on cardiopulmonary fitness and vascular function in sedentary post-menopausal women

Supervisor/Director of Studies

n/a

Principal Investigator

Dr Markos Klonizakis, Dr Garry Tew

Principal Investigator
telephone/mobile number

01142255590

Purpose of Study and Brief Description of Procedures
(Not a legal explanation but a simple statement)

Regular exercise is important to keep fit and healthy, particularly in post-menopausal women who have an increased risk of cardiovascular disorders. Unfortunately, a large proportion of the population does not perform enough exercise to achieve fitness and health benefits. Lack of time is often cited as a barrier to regular exercise. It is therefore important to identify time-efficient methods of exercising.

Recent studies have shown that “high-intensity interval training”, which involves short periods of hard exercise (for example, hard cycling) interspersed with short periods of recovery, is a time-efficient method of exercising. Indeed, despite a lower volume of exercise, this method of training can produce similar improvements in fitness and health as more traditional continuous exercise performed at a light-to-moderate intensity. However, the safety, acceptability and effectiveness of high-intensity interval training in older people is unclear.

This study will compare the safety, acceptability and effectiveness of high-intensity interval training with that of moderate-intensity continuous training in previously inactive post-menopausal women.

This study requires you to attend the research centre at Sheffield Hallam University on nine occasions.

Visit 1: 30-60 minutes duration
During your first visit, you will be asked questions about your health and will be fully familiarised with the testing procedures.

Visits 2 and 9: 90-120 minutes duration (testing session)
It is essential that no food or caffeine is consumed for two hours before these sessions and that you refrain from exercise and alcohol for 24 hours before. In these sessions, we will assess the health of your large and small blood vessels (vascular function), as well as your fitness on a cycling machine.

During the first vascular function test, you will be required to lie as still as possible whilst the ability of the artery in your upper arm to relax is examined. A blood vessel in your upper arm will be imaged using ultrasound whilst a blood pressure cuff is inflated around your forearm for 5 minutes. Inflation of the cuff may result in a "pins and needles" sensation in the fingers, but this will go away when the cuff is released. Once the cuff is deflated arterial scanning will be maintained for a further 5 minutes. After a 15 minute rest period a second scan will be performed where you will take 400 µl of glyceryl trinitrate (GTN), followed by a further 6 minutes of arterial scanning. GTN is taken by a spray under the tongue and may cause slight feelings of nausea or light headedness, but these feelings should go away within 10 minutes. Throughout the vascular function tests blood pressure will be taken from an additional cuff around the opposite arm.

The functioning of the small vessels of the skin will then be assessed my measuring the increase in skin blood flow that occurs in response to a brief interruption of blood flow and to the local application of non-painful heat. Blood flow to the arm will be briefly interrupted by inflating a blood pressure cuff on the upper arm for 5 minutes. This may cause a "pins and needles" sensation in the forearm and hand. Changes in skin blood flow will be measured using non-invasive probes placed on the forearm. Blood pressure will be taken throughout this test, which will take around 40-50 minutes to complete.

You will then complete a progressive cycling test to assess your fitness. During this test, you will be asked to cycle at a set speed. The cycle resistance will be light to begin with and it will get progressively harder. The aim for you is to keep exercising as long as possible. You will likely get hotter and out of breath towards the end of this test. You will be closely monitored during this test and no adverse side effects are expected. The cycling test will last around 15 minutes.

After the first assessment session (visit 2), you will be randomly allocated to a high-intensity interval training group or a moderate-intensity continuous exercise group. Both of these groups require you to undertake 6 sessions of supervised exercise (visits 3-8) over a 2-week period (3 sessions per week) at Sheffield Hallam University. Each session of high-intensity interval exercise will involve 60 seconds of hard cycling followed by 60 seconds of easy cycling, repeated ten times. Each session of moderate-intensity continuous exercise will involve 40 minutes of continuous cycling at a moderate intensity. You will be closely monitored during each of these sessions. After completing the six exercise sessions, you will be assessed again (visit 9, as described above).

Q:   Are side-effects associated with any of the procedures?
A:     The procedures we will be using are all well-established techniques which have been used with many volunteers in previous research studies without any side-effects being reported. Hence, no side-effects from any of the procedures are expected.

Q:  What if I do not wish to take part?
A:   This is OK.

Q:  What if I change my mind during the study?   
A:   You are free to withdraw from the study at any time without having to give a reason. However, your involvement to completion of all studies will greatly assist this research.

Q:  What will happen to the information from the study?     
A:  The overall conclusions of the study will be available to you. However, it will not be possible to produce an individualised report of your performance.

Q:  Is there anything else that I need to know?     
A:     If you agree to participate in this research study, it is essential that you abstain from food and caffeine within 2 h of testing. Restraint from exercise and alcohol for the 24 hours prior to any assessment sessions is also mandatory.

Q:   What if I have further questions?      
A:    If you have any further questions with regards to this study you may phone:-
Name: Dr Markos Klonizakis…………       Tel: 0114 225 5590………………………………
Name: Dr Garry Tew…………                   Tel: 0114 225 2358………………………………

It has been made clear to me that, should I feel that these Regulations are being infringed or that my interests are otherwise being ignored, neglected or denied, I should inform Professor Edward Winter, Chair of the Faculty of Health and Wellbeing Research Ethics Committee (Tel: 0114 225 4333) who will undertake to investigate my complaint.