Obesity Clinical Trial
Official title:
The Effect of (i) Physical Activity and (ii) Continuous Versus Intermittent Exercise Training Upon Cardiovascular and Cognitive Function in Obese Women
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Written informed consent will be gained following greater than 48 hours for the purpose of reading the Participant Information sheets. The study will then involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers (i.e. participants who volunteer to exercise train). Participants for stage 1 will then visit the laboratory in the University on three occasions (over a three week period) to be assessed for body composition, exercise tolerance, current physical activity levels, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who have volunteered for the exercise training component (approx 60). These participants will then be randomly divided into two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner at a moderate intensity, whilst the second group will exercise at a heavy intensity but in short bursts. Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
The study will involve two stages (i) recruiting participants for a cross sectional analysis
of the relationship between physical activity levels and cardiovascular and cognitive
function, and (ii) a longer exercise training study in a subsample of these volunteers. 100
participants for stage 1 will visit the laboratory in the University on three occasions
(within a three week period) to be assessed for anthropometric outcomes, body composition,
exercise tolerance, cognitive function and arterial and cardiac health. Each visit will last
for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a
period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will
include only those participants who are happy to continue into the exercise training phase.
These participants will then be matched for age and BMI and then randomly (on matched pairs)
allocated to one of two groups. Both groups will exercise three times per week for 12 weeks
duration. Group 1 will exercise in a traditional manner undertaking continuous exercise,
whilst the Group 2 will exercise at a heavy intensity but in short bursts (interval
exercise). Both groups will complete the same amount of work but in two differing modes.
Both groups will attend the laboratory twice per week for supervised exercise sessions and
also perform one home based 30 minute brisk walk per week. All participants will be
re-examined at 12 weeks.
Recruitment of participants
One hundred participants from a combination of (a) local advertisements and/or (b) those
whose details are held on a research database (of previous volunteers indicating willingness
to be contacted about future studies) will be sought to volunteer for this study.
Participants will be contacted via email/telephone/letter to provide information regarding
this study. All volunteers interested in participating will be contacted to provide general
information during a preliminary telephone screening interview. This will be used to check
main inclusion and exclusion criteria. The women who fit these criteria will be sent the
participant information sheet to read carefully and if still interested invited to attend
the first laboratory visit for a screening session. Participants have greater than 48 hours
to assess the participant information sheet before they attend this first visit when, if
eligible, they will be asked to provide written informed consent.
Laboratory Visits
Visit 1
During this visit the study and all procedures will be explained in detail to all
participants, and written informed consent will be taken. A thorough medical history will be
obtained and participants will be asked to complete a Recruitment Information Questionnaire
(RIQ) to confirm all inclusion/ exclusion criteria. Participants will complete the National
Adult Reading Test (NART) which estimates premorbid intelligence levels.
Participants will also complete a Physical Activity Readiness Questionnaire (PAR-Q) which
will be reviewed to determine whether participants are fit to continue with the study.
Simple measures of body weight, height and waist circumference will be taken. Participants
will complete a practice version of the cognitive test battery to demonstrate the tests,
ensure participants understand how to perform the tests correctly and assess compliance
(effort).
Participants will complete a cycling test on a stationary bicycle under the supervision of
the investigator and a medic.
Visit 2
The second visit will involve several measures of arterial health which requires
participants to attend in a 12 hour fasted state. Blood vessel function will be assessed
using a blood pressure cuff around the lower arm for a period of 5 minutes. Cardiac
structure and function will be assessed using two-dimensional (2D) echocardiography.
Vascular function will be assessed using ultrasound and applanation tonometry. All
procedures are non-invasive. Percentages of body fat and muscle mass will be measured using
bioimpedance.
A 60ml blood sample will be taken which will be used to asses endothelial progenitor cell
number and function, insulin sensitivity, cholesterol levels and is part of the assessment
for health of the arteries and vascular system.
Visit 3
On the third visit a cognitive function test will be completed, which requires participants
to attend in a 12 hour fasted state.
Participants will perform a 45 minute battery of cognitive tests. Following the cognitive
tests, participants will be asked to complete a cognitive test evaluation questionnaire to
assess both subjective and objective cognition.
At the end of the third laboratory visit all participants will be provided with an ActiHeart
accelerometer (Actigraph, Pensacola, USA) to wear for a period of one week in order to
assess movement counts and sedentary behaviour. At the end of the seven days the
accelerometer is given back to or collected by the team and the data downloaded.
The three baseline laboratory visits plus the seven days using the ActiHeart accelerometer
all come under stage 1 of the study. Participants will be asked to continue into the
exercise training stage (stage 2), and willing volunteers will move through to the second
stage of the experiment. All measures will be repeated at 12 weeks (78 hours to 5 days
following cessation of the last exercise training session).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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