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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05260905
Other study ID # NICR4297
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date August 2025

Study information

Verified date May 2024
Source University of Stirling
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Regular exercise is needed to ensure good general health and wellbeing. How exercise makes you feel (pleasant / unpleasant) is thought to be important for whether people will stick with a given exercise routine. Sprint interval training (SIT) has been shown be a time-efficient exercise strategy for improving health, but some researchers suggest that SIT may be experienced as unpleasant and therefore unsuitable as an exercise routine for improving general health and wellbeing. However, SIT protocols are diverse, and it has previously been shown that very short SIT protocols such as 'reduced-exertion high-intensity interval training' (REHIT) are not perceived as unpleasant, at least on average. Interestingly, how REHIT is perceived appears to be highly variable between individuals. This individual variability may have important implications for whether people stick with REHIT and/or SIT in real-world settings, and therefore it is important to characterise it and better understand why some people find this exercise unpleasant while others do not. This study aims to characterise the within-participant and between-participant variability in how people perceive REHIT. Furthermore, potential relationships between psychological characteristics and how people perceive REHIT will be explored.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
REHIT
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.

Locations

Country Name City State
United Kingdom University of Stirling Stirling Midlothian

Sponsors (5)

Lead Sponsor Collaborator
University of Stirling California State University, San Marcos, Swansea University, University of Edinburgh, University of Worcester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Body awareness and autonomic reactivity 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.
Other Anxiety sensitivity 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.
Other Preference for and tolerance of the intensity of exercise 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.
Other Sense of agency 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.
Other Exercise enjoyment 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.
Other Exercise power output 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.
Other Self efficacy to do exercise 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.
Primary Exercise-induced change in affective valence 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 Rating of perceived exertion (RPE) 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.
Secondary Felt arousal 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.
See also
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