- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05260905
Predictors of Affective Responses to Sprint Interval Exercise
Study Overview
Detailed Description
The study will recruit between 100-150 apparently healthy participants from multiple sites. Participants will be asked to complete the following questionnaires: Anxiety Sensitivity Index 3 (ASI-3), Body Perception Questionnaire (BPQ), Sense of Agency Scale (SoAS), and Preferences and Tolerances for High Intensity Exercise (PRETIE-Q). This data will be used to determine if changes in affective valence during REHIT are associated with the responses to these questionnaires.
Participants' maximal aerobic capacity (VO2max) will be determined using an incremental cycling test to exhaustion. Participants will start cycling on a stationary bike at a low intensity (30 W). The intensity will increase by 1 W every 3 seconds until volitional exhaustion or an inability to maintain a pedalling frequency of >60 rpm. Expired O2 and CO2 will be continuously measured breath-by-breath using an online gas analyser. VO2max will be determined as the highest value for a 15-breath rolling average of VO2. VO2max will be accepted if at least 2 of the following criteria are met: volitional exhaustion, inability to maintain a pedal frequency of 60 rpm, RER>1.10, a plateau in VO2, and/or heart rate within 10 bpm of the age predicted maximum (220-age).
Participants will practice REHIT exercise on 2 occasions. Each session will be performed on a mechanically-braked cycle ergometer. REHIT consists of 10 minutes of unloaded cycling interjected with 2 maximal sprints against a resistance equivalent to 7.5% baseline body mass. In the first practice session the sprints will be 10 seconds long; in the second practice session they will be 15 seconds long. Sprints will finish at 2 minutes and 6 minutes into the session. The scales for rating of perceived exertion (RPE, Borg scale), affect (Feeling scale), and arousal (Felt Arousal) will be explained to the participants during the familiarisation sessions.
The final 2 sessions are the experimental sessions and will involve REHIT sessions with 20-second sprints. The Demand and Resource Questionnaire will be administered pre-exercise. Affect (Feeling scale) and arousal (Felt Arousal) will be measured at rest before exercise and at the end of every minute during exercise. Rating of perceived exertion (RPE, Borg scale) will be measured at the same time-points but during exercise only. Heart rate and power output will be measured throughout the 10-minute exercise session. The Physical Activity Enjoyment Scale (PACES) will be administered 10 minutes after exercise.
Within- and between-participant variability in the change in affect with exercise will be determined. Potential associations between psychology questionnaire scores and the change in affect with exercise will be explored.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Midlothian
-
Stirling, Midlothian, United Kingdom, FK9 4LA
- University of Stirling
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Apparently healthy
- Sedentary or recreationally active
Exclusion Criteria:
- Classified as highly physically active on the International Physical Activity Questionnaire (IPAQ)
- Answering 'Yes' to any of the questions of a standard Physical Activity Readiness Questionnaire (PAR-Q)
- Resting heart rate >100 bpm
- Resting blood pressure > 140/90 mm Hg
- BMI > 35 kg/m2
- Testing positive for Covid-19
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention
All participants will perform 2 experimental sessions, each involving a REHIT exercise session.
|
REHIt involves 10 minutes of unloaded cycling on a stationary bike, interspersed with two 20-s 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise-induced change in affective valence
Time Frame: Affective valence will be measured before exercise and at the end of every minute during the 10-minute exercise trials. The outcome measure will be determined as the differences between the pre-exercise measurement and the lowest value during exercise.
|
Affective valence is a measure of how pleasant / unpleasant the exercise is and will be measured using the 11-point Feeling Scale pre-exercise (ranging from 5 (very bad) to 5 (very good)), and at the end of every minute during exercise.
The change in affect will be calculated as the difference between the pre-exercise value and the lowest value during exercise.
This will be measured during both experimental sessions.
|
Affective valence will be measured before exercise and at the end of every minute during the 10-minute exercise trials. The outcome measure will be determined as the differences between the pre-exercise measurement and the lowest value during exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of perceived exertion (RPE)
Time Frame: RPE will be measured at the end of every minute during the 10-minute exercise trials.
|
RPE is a measure of how hard an exercise session is perceived to be and will be measured using the 15-point Borg scale (ranging from 6 (very very light) to 20 (very very hard) at the end of every minute during exercise.
RPE will be measured during both experimental sessions.
|
RPE will be measured at the end of every minute during the 10-minute exercise trials.
|
|
Felt arousal
Time Frame: Felt arousal will be measured at the end of every minute during the 10-minute exercise trials.
|
Felt arousal is a measure of perceived activation and will be measured using the Felt Arousal Scale (FAS) along a 6-point scale (ranging from low arousal (1) to high arousal (6)), at the end of every minute during exercise.
Felt arousal will be measured during both experimental sessions.
|
Felt arousal will be measured at the end of every minute during the 10-minute exercise trials.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body awareness and autonomic reactivity
Time Frame: Body awareness and autonomic reactivity will be measured at the start of the study before any exercise sessions are performed.
|
Body awareness and autonomic reactivity will be measured using the Body Perception Questionnaire (BPQ), with scores ranging from 26 (poor body awareness and autonomic reactivity) to 118 (excellent body awareness and autonomic reactivity).
|
Body awareness and autonomic reactivity will be measured at the start of the study before any exercise sessions are performed.
|
|
Anxiety sensitivity
Time Frame: Anxiety sensitivity will be measured at the start of the study before any exercise sessions are performed.
|
Anxiety sensitivity measures concern associated with possible negative consequences of anxiety-related symptoms and is assessed using the Anxiety Sensitivity Index-3 (ASI-3) on a scale from 0 (almost no anxiety sensitivity) to 72 (high anxiety sensitivity).
|
Anxiety sensitivity will be measured at the start of the study before any exercise sessions are performed.
|
|
Preference for and tolerance of the intensity of exercise
Time Frame: Preference for and tolerance of the intensity of exercise will be measured at the start of the study before any exercise sessions are performed.
|
Preference for and tolerance of the intensity of exercise will be assessed using the PRETIE-Q questionnaire.
Preference for the intensity of exercise is measured on a scale from 8 (low) to 40 (high) and tolerance of the intensity of exercise is measured on a scale from 8 (low) to 40 (high).
|
Preference for and tolerance of the intensity of exercise will be measured at the start of the study before any exercise sessions are performed.
|
|
Sense of agency
Time Frame: Sense of agency will be measured at the start of the study before any exercise sessions are performed.
|
Sense of agency is a measure of to what extent someone feels they are the initiator of their own actions, and will will be assessed using the Sense of Agency Scale (SoAS) on a scale of 13 (low sense of agency) to 91 (high sense of agency).
|
Sense of agency will be measured at the start of the study before any exercise sessions are performed.
|
|
Exercise enjoyment
Time Frame: Exercise enjoyment will be measured 10 minutes after the final experimental exercise session.
|
Exercise enjoyment will be measured using the Physical Activity Enjoyment Scale (PACES), on a scale from 0 (no enjoyment) to 48 (very high enjoyment).
|
Exercise enjoyment will be measured 10 minutes after the final experimental exercise session.
|
|
Exercise power output
Time Frame: Power output will be measured continuously during each of the 2 20-second cycle sprints in the exercise trials.
|
Power output during the 'all-out' cycle sprints will be measured, and quantified as the peak power output (in Watts), mean power output (in Watts), and fatigue index (drop in power from highest to lowest, expressed as a percentage of peak power output).
|
Power output will be measured continuously during each of the 2 20-second cycle sprints in the exercise trials.
|
|
Self efficacy to do exercise
Time Frame: Self efficacy will be measured directly before each of the two experimental trials.
|
Self efficacy will be assessed using the Demand and Resource Questionnaire, which assesses how demanding the participants consider the upcoming exercise to be (on a scale from 1 (not at all) to 6 (extremely)), and how well they think they will cope with these demands (on a scale from 1 (not at all) to 6 (extremely)).
|
Self efficacy will be measured directly before each of the two experimental trials.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Niels Vollaard, PhD, University of Stirling
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NICR4297
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Health
-
Apple Inc.Brigham and Women's Hospital; MCRARecruitingWellbeing | Sleep | Exercise | Aging | Mental Health | Women's Health | Functional Capacity | Hormones | Neurological Conditions | General Health | Lifestyle Factors | Metabolic Health | HearingUnited States
-
University of Wisconsin, MadisonNational Center for Complementary and Integrative Health (NCCIH)CompletedMental Health | HealthUnited States
-
BIO-CAT Microbials, LLCBiofortis Clinical Research, Inc.CompletedImmune Health | Cardiovascular Health | Gastrointestinal Health | Digestive HealthUnited States
-
University Hospital, ToursiBrain, Inserm U1253; Research Center for Respiratory Diseases, Inserm U1100CompletedPhysical Health | Psychological HealthFrance
-
Marmara UniversityCompleted
-
University of StirlingCompletedGeneral HealthUnited Kingdom
-
University of ArkansasArkansas Center for Health ImprovementCompletedHealth Policy | Health Care Reform
-
Universiti Teknologi MaraUniversiti Putra Malaysia; Ministry of Health, Malaysia; Institute for Health... and other collaboratorsRecruitingHealth Attitude | Health Behavior | Knowledge, Attitudes, Practice | Health Knowledge, Attitudes, Practice | Health-Related Behavior | Behavior, Health | Attitude to Health | Preparedness | OutbreaksMalaysia
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Attitude | Health Behavior | Health KnowledgeTurkey
Clinical Trials on REHIT
-
Istinye UniversityCompletedObesity | Exercise | Oxygen ConsumptionTurkey
-
University of BathWithdrawnProstate CancerUnited Kingdom
-
University of StirlingSwansea UniversityCompletedHealth BehaviorUnited Kingdom
-
Foundation University IslamabadActive, not recruiting
-
University of StirlingOxford Brookes University; University of BathWithdrawn
-
Loughborough UniversityKarolinska Institutet; University of Nottingham; University of Copenhagen; Duke... and other collaboratorsCompletedPhysical Activity | Insulin SensitivityUnited Kingdom
-
University of StirlingCompletedMental Health Wellness 1United Kingdom
-
University of StirlingCompletedGeneral HealthUnited Kingdom
-
University of StirlingCompletedHealth BehaviorUnited Kingdom