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Physical Activity and Intermittent Exercise Training for Cardiovascular and Cognitive Gain in Obese Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853279
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Karen Birch, University of Leeds

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Cognitive Ability, General Cardiovascular Disease Behavioral: Interval exercise training Behavioral: Continuous exercise training (CON) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of (i) Physical Activity and (ii) Continuous Versus Intermittent Exercise Training Upon Cardiovascular and Cognitive Function in Obese Women
Study Start Date : June 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interval exercise training
Supervised exercise training undertaking interval exercise twice per week for 30 min each visit over 12 weeks.
Behavioral: Interval exercise training

Interval exercise sessions (INT) involving work:recovery ratios of 40 s at 70% delta work-rate followed by 80 s active recovery at 20 W. 70% delta (∆) is 70% of the difference between work rate peak (WRpeak) and work rate at the lactate threshold (WRLT) calculated as:

70%∆ =0.7(〖WR〗_peak- 〖WR〗_LT )+ 〖WR〗_LT

Where WR is work rate, LT is lactate threshold)

Each session was for 30 min and this was undertaken twice per week for 12 weeks. One home based exercise session was incorporated per week.


Active Comparator: Continuous exercise training
Supervised exercise training undertaking continuous exercise twice per week for 30 min each visit over 12 weeks.
Behavioral: Continuous exercise training (CON)
Exercise sessions involved cycling at 20%∆ work-rate peak for the duration of the session. This work-rate was chosen so that all participants in the group would be exercising in the heavy-intensity domain. To enable participants in the CON exercise group to complete the same amount of work (kJ) as the participants in the INT exercise group, the amount of work that would be completed if the CON participants completed an INT exercise session was calculated. Participants exercised for 26 min (varying to match interval group) twice per week for 12 weeks.




Primary Outcome Measures :
  1. Maximal oxygen uptake (CPX) [ Time Frame: Change at 12 weeks ]
    Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test.

  2. Flow mediated dilatation [ Time Frame: Change at 12 weeks ]
    Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound.


Secondary Outcome Measures :
  1. Lactate threshold [ Time Frame: Baseline and 12 weeks ]
    Lactate threshold estimated from pulmonary gas exchange criteria

  2. Blood borne (plasma) inflammatory marker [ Time Frame: Baseline and 12 weeks ]
    high sensitivity C reactive protein

  3. Work rate peak [ Time Frame: Baseline and 12 weeks ]
    The peak work rate achieved during the maximal oxygen uptake assessment

  4. Circulating angiogenic cell number [ Time Frame: Baseline and 12 weeks ]
    CD34+CD45dimKDR+ via Flow cytometry

  5. Circulating cytokines [ Time Frame: Baseline and 12 weeks ]
    vascular endothelial growth factor

  6. Circulating cytokines [ Time Frame: Baseline and 12 weeks ]
    stromal derived factor 1

  7. Arterial stiffness [ Time Frame: Baseline and 12 weeks ]
    Doppler assessed and Sphygmacor assessed changes in stiffness via pulse wave velocity

  8. Cognitive function (Visual spatial learning scale) [ Time Frame: Baseline and 12 weeks ]
  9. Cognitive function (Tower of Hanoi) [ Time Frame: Baseline and 12 weeks ]
  10. Cognitive function (Grooved peg board) [ Time Frame: Baseline and 12 weeks ]
  11. Cognitive function (Visual verbal learning scale) [ Time Frame: Baseline and 12 weeks ]
  12. Cognitive function (Bakan test)) [ Time Frame: Baseline and 12 weeks ]
  13. Cognitive function (Corsi block tapping) [ Time Frame: Baseline and 12 weeks ]
  14. Physical activity level [ Time Frame: Baseline and 12 weeks ]
    Accelerometer assessed physical activity (Actiheart) worn on the hip

  15. Blood pressure [ Time Frame: Baseline and 12 weeks ]
    Blood pressure

  16. Body composition [ Time Frame: Baseline and 12 weeks ]
    Bioelectrical impedence analysis (BIOSTAT) assessment of fat mass

  17. Cardiac function (echocardiography) [ Time Frame: Baseline and 12 weeks ]
  18. Cardiac structure (echocardiography) [ Time Frame: Baseline and 12 weeks ]
  19. Adhesion of cultured angiogenic cells to vascular smooth muscle cells [ Time Frame: Baseline and 12 weeks ]
    Number of cells adhering



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853279


Locations
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United Kingdom
Centre for Sports and Exercise Sciences, University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Human Appetite Research Unit
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Karen M Birch, PhD University of Leeds
Additional Information:
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Responsible Party: Karen Birch, Chief Investigator, University of Leeds
ClinicalTrials.gov Identifier: NCT02853279    
Other Study ID Numbers: BIOSCI 10-021
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiovascular Diseases