NCT02311738

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable obesity

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

8.6 years

First QC Date

June 26, 2014

Last Update Submit

September 22, 2021

Conditions

Obesity

Keywords

Exercise and Genes in Obese (EGO)

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure during physical activity

    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.

    0, 8, 12 and 24 weeks

Secondary Outcomes (14)

  • 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

  • Fat mass and fat free mass

    0, 8, 12 and 24 weeks

  • +9 more secondary outcomes

Other Outcomes (4)

  • Substrate oxidation

    0, 8, 12 and 24 weeks

  • Hip circumference

    0, 8, 12 and 24 weeks

  • Daily activity

    0, 17 and 24 weeks

  • +1 more other outcomes

Study Arms (2)

High intensity training group

EXPERIMENTAL

HIE will consist of the following: 1. 10 minute warm up at 70% of maximal heart rate. 2. 4 minute exercise intervals at 90-95% of maximal heart rate. 3. 4 minute interval bouts repeated 4 times. 4. Between each bouts there will be a 3 minute active recovery at 70% of maximal heart rate 5. After all four bouts are completed; 5 minute cool-down at 70% of maximal heart rate.

Other: Training intensity intervention

Moderate intensity training group

EXPERIMENTAL

MIE will consist of the following: 1. 10 minute warm up at 50% of maximal heart rate. 2. 35 minutes exercise at 70% of maximal heart rate. 3. 4 minute cool-down at 50% of maximal heart rate.

Other: Training intensity intervention

Interventions

Training intensity interventionOTHER

High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention

Also known as: EGO-HIT
High intensity training groupModerate intensity training group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Duke University School of Medicine

Durham, North Carolina, 27708, United States

Location

Vestfold University College

Horten, Raveien, 3184, Norway

Location

Telemark University College

Bø, 3800, Norway

Location

University in Agder

Kristiansand, 4630, Norway

Location

Norges Teknisk-naturvitenskapelig Universitet

Trondheim, 7491, Norway

Location

Vestfold Hospital Trust

Tønsberg, 3103, Norway

Location

Related Publications (2)

  • Berge J, Hjelmesaeth J, Kolotkin RL, Storen O, Bratland-Sanda S, Hertel JK, Gjevestad E, Smastuen MC, Helgerud J, Bernklev T. Effect of aerobic exercise intensity on health-related quality of life in severe obesity: a randomized controlled trial. Health Qual Life Outcomes. 2022 Feb 24;20(1):34. doi: 10.1186/s12955-022-01940-y.

    PMID: 35209911DERIVED

  • Berge J, Hjelmesaeth J, Hertel JK, Gjevestad E, Smastuen MC, Johnson LK, Martins C, Andersen E, Helgerud J, Storen O. Effect of Aerobic Exercise Intensity on Energy Expenditure and Weight Loss in Severe Obesity-A Randomized Controlled Trial. Obesity (Silver Spring). 2021 Feb;29(2):359-369. doi: 10.1002/oby.23078.

    PMID: 33491314DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jøran Hjelmesæth, professor

    The Hospital of Vestfold

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD-Fellow

Study Record Dates

First Submitted

June 26, 2014

First Posted

December 8, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

NO(5)US(1)