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Affective Responses Following Aerobic Exercise With Different Intensities

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ClinicalTrials.gov Identifier: NCT03081520
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Telemark University College

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE March 16, 2017
Last Update Posted Date June 18, 2018
Actual Study Start Date  ICMJE September 5, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
Change in self rated well-being rated on a Visual Analogue Scale [ Time Frame: Two weeks ]
well-being rated on a Visual Analogue Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03081520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Self-reported change in affects using Positive and Negative Affect Scale [ Time Frame: Two weeks ]
    Positive and Negative Affect Scale
  • Self-reported change in physical activity motivation using Behavioural Regulation of Exercise Questionnaire - 2 [ Time Frame: Two weeks ]
    Behavioural Regulation of Exercise Questionnaire - 2
  • Self-reported change in affective responses using Self-Assessment Manikin Rating Scale [ Time Frame: Two weeks ]
    Self-Assessment Manikin Rating Scale
  • Self-reported change in mood using scale Profile of Mood States [ Time Frame: Two weeks ]
    Use of the standardized and validated scale Profile of Mood States
  • Perceived exercise intensity during each exercise session using Borgs Ratings of Perceived Exertion (RPE) scale (6-20) [ Time Frame: At minutes 0,10, 20, 40 and 50 in each exercise session ]
    Borgs RPE scale (6-20)
  • Lactate during each exercise session (mMol/l) [ Time Frame: At minutes 0,10, 20, 40 and 50 in each exercise session ]
    Blood lactate samples (mMol/l)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Self-reported change in affects using Positive and Negative Affect Scale [ Time Frame: Two weeks ]
    Positive and Negative Affect Scale
  • Self-reported change in physical activity motivation using Behavioural Regulation of Exercise Questionnaire - 2 [ Time Frame: Two weeks ]
    Behavioural Regulation of Exercise Questionnaire - 2
  • Self-reported change in affective responses using Self-Assessment Manikin Rating Scale [ Time Frame: Two weeks ]
    Self-Assessment Manikin Rating Scale
  • Self-reported change in mood using scale Profile of Mood States [ Time Frame: Two weeks ]
    Use of the standardized and validated scale Profile of Mood States
  • Perceived exercise intensity during each exercise session using Borgs RPE scale (6-20) [ Time Frame: At minutes 0,10, 20, 40 and 50 in each exercise session ]
    Borgs RPE scale (6-20)
  • Lactate during each exercise session (mMol/l) [ Time Frame: At minutes 0,10, 20, 40 and 50 in each exercise session ]
    Blood lactate samples (mMol/l)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Affective Responses Following Aerobic Exercise With Different Intensities
Official Title  ICMJE Affective Responses Following Aerobic Exercise With Different Intensities
Brief Summary The aim of this study is to examine acute affective responses during and after a series of exercise sessions with different intensities in young healthy adults. The study is a randomized controlled trial with three different groups (A: moderate continuous training (MIT), B: high-intensity aerobe interval training (HAIT), C: high-intensity sprint interval training (HIIT)). Healthy adults aged 18-40 years (n=30) will be invited to participate. Each participant will perform a VO2max test followed by five session of the randomized type of training. The sessions will be completed within two weeks. The participants will complete questionnaires regarding exercise motivation (Behavioral Regulation of Exercise Questionnaire), mood (Positive and Negative Affect Scale, Profile of Mood States, Visual Analogue scale, Self-assessment Manikin Rating Scale) and perceived exhaustion (Borg Ratings of Perceived Exertion scale). In addition, blood lactate and heart rate will be obtained during and after each session.
Detailed Description

Physical activity has is considered as one of the most important health related aspects of the 21st century. In Norway, large epidemiological studies show that only about 30% of the adult population meet the physical activity recommendations of 150 minutes per week with moderate-to-vigorous intensity physical activity. Also, studies show that there are large dropout rates from lifestyle interventions, and that approximately 50% drop out from physical activity interventions within 6 months after start. One explanation for the dropout is performance of exercise with too vigorous intensities.

Very vigorous intensity physical activity can be experienced as unpleasant. According to the dual-mode theory there are positive affective responses after low-to-moderate intensity physical activity, whereas vigorous intensity physical activity trigger negative affective responses which again can lead to reduced motivation for the exercise. Unfortunately, many of the studies performed on affective responses to exercise have used one session only. The studies who have examined changes in affective responses after series of exercise have used vigorous intensities above the anaerobic threshold, and it is therefore unknown whether similar affective responses occur in vigorous intensity aerobe exercise.

The aim of this study is to examine acute affective responses during and after a series of exercise sessions with different intensities in young healthy adults.

To examine this, a randomized controlled clinical trial with three different groups (moderate intensity training (MIT), high-intensity aerobic interval training (HAIT) and high-intensity sprint interval training (HIIT)) will be conducted. A power calculation showed need for recruitment of 30 participants. The sample will consist of healthy young adults. All participants will perform one VO2max test, and five sessions with the intensity they are randomized to. All six sessions (test + exercise sessions) will be conducted within two weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Health Behavior
Intervention  ICMJE
  • Behavioral: Affective response MIT
    Examine acute affective responses during and after five sessions of endurance training with moderate intensity continuous training
  • Behavioral: Affective response HAIT
    Examine acute affective responses during and after five sessions of endurance training with high-intensity aerobic interval training
  • Behavioral: Affective response HIIT
    Examine acute affective responses during and after five sessions of endurance training with high-intensity sprint interval training
Study Arms  ICMJE
  • Experimental: Affective response MIT
    Moderate intensity continuous training 50 min with walking or running on approximately 75% of HRmax
    Intervention: Behavioral: Affective response MIT
  • Experimental: Affective response HAIT
    High-Intensity Aerobic Interval Training 4x4 min with walking or running on 85-95% of HRmax 3 min active recovery between sets, intensity of approximately 70% of HRmax
    Intervention: Behavioral: Affective response HAIT
  • Experimental: Affective response HIIT
    High-Intensity Interval Training 4-6 x 30-sec sprints on tread mill, >95% HRmax during sprints 4 min recovery between sprints, intensity of approximately 70% of HRmax
    Intervention: Behavioral: Affective response HIIT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2017)
30
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • No high intensity interval training during the past three months prior to participation
  • Regular exercise up to two sessions per week
  • 18-40 years of age
  • BMI <30 kg/m2

Exclusion Criteria:

  • Competing athlete
  • Smoker
  • Injury not compatible with performing the exercises
  • BMI <16 kg/m2
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03081520
Other Study ID Numbers  ICMJE Affective responses exercise
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Telemark University College
Study Sponsor  ICMJE Telemark University College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Solfrid Bratland-Sanda, PhD University College of Southeast Norway
PRS Account Telemark University College
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP