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
Verified date | July 2016 |
Source | University of Leeds |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Sedentary women (exercise =2 day per week) - Pre-menopausal (age 35- 50 years) - BMI of =30 kg/m2 - Able to give informed consent . - Non-smokers - Vision sufficiently good to complete the cognitive testing (using glasses and/or lenses). Exclusion Criteria: - Male - BMI < 30 kg/m2 - Clinically diagnosed with type 1 or type 2 diabetes - Resting/exercise ECG indicating significant ischemia, recent myocardial infarction or other acute cardiac event or other exercise related ECG abnormalities. - Unstable angina. - Uncontrolled hypertension. - Uncontrolled cardiac dysrhythmias - The use of antidepressant, antianxiety, or thyroid medication. - Dementia - Neurological disorder - Previous stroke or Transient Ischaemic Attack (TIA) - Musculoskeletal impairment or injury - Medication that has a direct effect on the brain and is likely to influence cognitive function. - Current smokers or those who have given up in the previous 6 months |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Sports and Exercise Sciences, University of Leeds | Leeds | West Yorkshire |
United Kingdom | Human Appetite Research Unit | Leeds | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
University of Leeds |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal oxygen uptake (CPX) | Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test. | Change at 12 weeks | Yes |
Primary | Flow mediated dilatation | Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound. | Change at 12 weeks | No |
Secondary | Lactate threshold | Lactate threshold estimated from pulmonary gas exchange criteria | Baseline and 12 weeks | No |
Secondary | Blood borne (plasma) inflammatory marker | high sensitivity C reactive protein | Baseline and 12 weeks | No |
Secondary | Work rate peak | The peak work rate achieved during the maximal oxygen uptake assessment | Baseline and 12 weeks | No |
Secondary | Circulating angiogenic cell number | CD34+CD45dimKDR+ via Flow cytometry | Baseline and 12 weeks | No |
Secondary | Circulating cytokines | vascular endothelial growth factor | Baseline and 12 weeks | No |
Secondary | Circulating cytokines | stromal derived factor 1 | Baseline and 12 weeks | No |
Secondary | Arterial stiffness | Doppler assessed and Sphygmacor assessed changes in stiffness via pulse wave velocity | Baseline and 12 weeks | No |
Secondary | Cognitive function (Visual spatial learning scale) | Baseline and 12 weeks | No | |
Secondary | Cognitive function (Tower of Hanoi) | Baseline and 12 weeks | No | |
Secondary | Cognitive function (Grooved peg board) | Baseline and 12 weeks | No | |
Secondary | Cognitive function (Visual verbal learning scale) | Baseline and 12 weeks | No | |
Secondary | Cognitive function (Bakan test)) | Baseline and 12 weeks | No | |
Secondary | Cognitive function (Corsi block tapping) | Baseline and 12 weeks | No | |
Secondary | Physical activity level | Accelerometer assessed physical activity (Actiheart) worn on the hip | Baseline and 12 weeks | No |
Secondary | Blood pressure | Blood pressure | Baseline and 12 weeks | No |
Secondary | Body composition | Bioelectrical impedence analysis (BIOSTAT) assessment of fat mass | Baseline and 12 weeks | No |
Secondary | Cardiac function (echocardiography) | Baseline and 12 weeks | No | |
Secondary | Cardiac structure (echocardiography) | Baseline and 12 weeks | No | |
Secondary | Adhesion of cultured angiogenic cells to vascular smooth muscle cells | Number of cells adhering | Baseline and 12 weeks | No |
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