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

NCT02853279 | Completed

• 1 other identifier: BIOSCI 10-021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Cognitive Ability, General; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Maximal oxygen uptake (CPX)

  Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test.

  Change at 12 weeks

• Flow mediated dilatation

  Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound.

  Change at 12 weeks

Secondary Outcomes (19)

• Lactate threshold

  Baseline and 12 weeks

• Blood borne (plasma) inflammatory marker

  Baseline and 12 weeks

• Work rate peak

  Baseline and 12 weeks

• Circulating angiogenic cell number

  Baseline and 12 weeks

• Circulating cytokines

  Baseline and 12 weeks

Study Arms (2)

Interval exercise training

EXPERIMENTAL

Supervised exercise training undertaking interval exercise twice per week for 30 min each visit over 12 weeks.

Behavioral: Interval exercise training

Continuous exercise training

ACTIVE COMPARATOR

Supervised exercise training undertaking continuous exercise twice per week for 30 min each visit over 12 weeks.

Behavioral: Continuous exercise training (CON)

Interventions

Interval exercise training BEHAVIORAL

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.

Interval exercise training

Continuous exercise training (CON) BEHAVIORAL

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.

Continuous exercise training

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (2)

Centre for Sports and Exercise Sciences, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Human Appetite Research Unit

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Links

• 3 abstracts presented to the annual congress of the European College of Sports and Exercise Sciences, Barcelona, Spain, 2013

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen M Birch, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 2, 2016
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)