The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 12
- Primary Endpoint
- Energy expenditure during physical activity
Study Overview
Brief Summary
Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown.
This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Treatment seeking weight stable morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient Obesity Center, Vestfold Hospital Trust, will be informed about this RCT .
Exclusion Criteria
- •Uncompensated heart failure
- •Recent myocardial infarction or stroke (<½ years)
- •Severe arrhythmia or heart failure
- •Unstable angina pectoris
- •Renal failure
- •Pregnancy
- •Severe eating disorders
- •Active substance abuse
- •Being on a diet
- •Taking medication known to affect appetite or metabolism (including thyroxin).
Outcomes
Primary Outcomes
Energy expenditure during physical activity
Time Frame: 0, 8, 12 and 24 weeks
Energy expenditure (EE) during volitional activity will be measured with ergo-spirometry tests one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give the same proportional increase in energy expenditure at any given maximal intensity.
Secondary Outcomes
- Fat mass and fat free mass(0, 8, 12 and 24 weeks)
- Binge Eating Scale (BES)(0,12 and 24 weeks)
- Resting metabolic rate(0, 8, 12 and 24 weeks)
- Cardiorespiratory fitness(0, 8, 12 and 24 weeks)
- Body mass index(0, 8, 12 and 24 weeks)
- Waist circumference(0, 8, 12 and 24 weeks)
- Appetite control(0,12 and 24 weeks)
- Body weight change(0, 8, 12 and 24 weeks)
- Genetic susceptibility(0, 8, 12 and 24 weeks)
- Impact on Weight Questionnaire (IWQOL-Lite)(0,12 and 24 weeks)
- Short form health survey (RAND-36)(0,12 and 24 weeks)
- Weight-Related Symptom Measure (WRSM)(0,12 and 24 weeks)
- Power of Food scale (PFS)(0,12 and 24 weeks)
- Three Factor Eating Questionnaire (TFEQ -R21)(0,12 and 24 weeks)
Investigators
Jarle Berge
PhD-Fellow
Sykehuset i Vestfold HF