Health BehaviorNCT03081520
Affective Responses Following Aerobic Exercise With Different Intensities
A study testing Affective response MIT, Affective response HAIT and Affective response HIIT in people with Health Behavior, run by University of South-Eastern Norway at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Affective response MIT, Affective response HAIT and Affective response HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 5 Sep 2017to 15 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Competing athlete
- Smoker
- Injury not compatible with performing the exercises
- BMI <16 kg/m2
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Affective response MIT, Affective response HAIT, Affective response HIIT
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective response MITBehavioural
Examine acute affective responses during and after five sessions of endurance training with moderate intensity continuous training
Affective response HAITBehavioural
Examine acute affective responses during and after five sessions of endurance training with high-intensity aerobic interval training
Affective response HIITBehavioural
Examine acute affective responses during and after five sessions of endurance training with high-intensity sprint interval training
| Study group | Role | What they receive |
|---|---|---|
| Affective response MIT | Experimental | Moderate intensity continuous training 50 min with walking or running on approximately 75% of HRmax Receives: Behavioral: Affective response MIT |
| Affective response HAIT | Experimental | 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 Receives: Behavioral: Affective response HAIT |
| Affective response HIIT | Experimental | 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 Receives: Behavioral: Affective response HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self rated well-being rated on a Visual Analogue Scale
well-being rated on a Visual Analogue Scale
Measured: Two weeks
Secondary outcomes (6)
Self-reported change in affects using Positive and Negative Affect Scale
Positive and Negative Affect Scale
Measured: Two weeks
Self-reported change in physical activity motivation using Behavioural Regulation of Exercise Questionnaire - 2
Behavioural Regulation of Exercise Questionnaire - 2
Measured: Two weeks
Self-reported change in affective responses using Self-Assessment Manikin Rating Scale
Self-Assessment Manikin Rating Scale
Measured: Two weeks
Self-reported change in mood using scale Profile of Mood States
Use of the standardized and validated scale Profile of Mood States
Measured: Two weeks
Perceived exercise intensity during each exercise session using Borgs Ratings of Perceived Exertion (RPE) scale (6-20)
Borgs RPE scale (6-20)
Measured: At minutes 0,10, 20, 40 and 50 in each exercise session
Lactate during each exercise session (mMol/l)
Blood lactate samples (mMol/l)
Measured: At minutes 0,10, 20, 40 and 50 in each exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start5 Sep 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South-Eastern Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solfrid Bratland-Sanda, PhD, Principal investigator, University College of Southeast Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081520
- Sponsor's protocol ID
- Affective responses exercise
- Status last verified
- Jul 2017
- First submitted
- 7 Mar 2017
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saanijoki T, Nummenmaa L, Eskelinen JJ, Savolainen AM, Vahlberg T, Kalliokoski KK, Hannukainen JC. Affective Responses to Repeated Sessions of High-Intensity Interval Training. Med Sci Sports Exerc. 2015 Dec;47(12):2604-11. doi: 10.1249/MSS.0000000000000721.
PubMed 26110694Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
PubMed 21780850Williams DM. Exercise, affect, and adherence: an integrated model and a case for self-paced exercise. J Sport Exerc Psychol. 2008 Oct;30(5):471-96. doi: 10.1123/jsep.30.5.471.
PubMed 18971508
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Responses Following Aerobic Exercise With Different Intensities
- ClinicalTrials.gov ID
- NCT03081520
- Acronym / sponsor ID
- Affective responses exercise
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of South-Eastern NorwayUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Affective response MIT | Experimental | Behavioral: Affective response MITModerate intensity continuous training 50 min with walking or running on approximately 75% of HRmax |
| Affective response HAIT | Experimental | Behavioral: Affective response HAITHigh-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 |
| Affective response HIIT | Experimental | Behavioral: Affective response HIITHigh-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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Competing athlete
- Smoker
- Injury not compatible with performing the exercises
- BMI <16 kg/m2
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective response MITExamine acute affective responses during and after five sessions of endurance training with moderate intensity continuous training | Behavioural | Affective response MIT |
| Affective response HAITExamine acute affective responses during and after five sessions of endurance training with high-intensity aerobic interval training | Behavioural | Affective response HAIT |
| Affective response HIITExamine acute affective responses during and after five sessions of endurance training with high-intensity sprint interval training | Behavioural | Affective response HIIT |
Primary outcome
Change in self rated well-being rated on a Visual Analogue Scale
Time frame: Two weeks
well-being rated on a Visual Analogue Scale
6 secondary outcomes
Self-reported change in affects using Positive and Negative Affect Scale
Time frame: Two weeks
Self-reported change in physical activity motivation using Behavioural Regulation of Exercise Questionnaire - 2
Time frame: Two weeks
Self-reported change in affective responses using Self-Assessment Manikin Rating Scale
Time frame: Two weeks
Self-reported change in mood using scale Profile of Mood States
Time frame: Two weeks
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
Lactate during each exercise session (mMol/l)
Time frame: At minutes 0,10, 20, 40 and 50 in each exercise session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Background: PubMed 26110694Saanijoki T, Nummenmaa L, Eskelinen JJ, Savolainen AM, Vahlberg T, Kalliokoski KK, Hannukainen JC. Affective Responses to Repeated Sessions of High-Intensity Interval Training. Med Sci Sports Exerc. 2015 Dec;47(12):2604-11. doi: 10.1249/MSS.0000000000000721.
- Background: PubMed 21780850Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
- Background: PubMed 18971508Williams DM. Exercise, affect, and adherence: an integrated model and a case for self-paced exercise. J Sport Exerc Psychol. 2008 Oct;30(5):471-96. doi: 10.1123/jsep.30.5.471.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solfrid Bratland-Sanda, PhD principal investigator
University College of Southeast Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective response MIT, Affective response HAIT and Affective response HIIT in people with Health Behavior, run by University of South-Eastern Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self rated well-being rated on a Visual Analogue Scale (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081520, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.