- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05721521
The Effects of Exercise Intensity on Mood and Wellbeing
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom
- University of Reading
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-30 years old
Exclusion Criteria:
- If participants' General Practitioner (GP) has advised them against exercising at low, moderate or high intensities
- Recent injuries within the last 12 weeks
- Physical health conditions that may be affected by exercising (e.g., asthma)
- Taking blood pressure medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High intensity
|
30 minute spin bike class led by a qualified instructor.
|
|
Experimental: Moderate intensity
|
30 minute spin bike class led by a qualified instructor.
|
|
Experimental: Low intensity
|
30 minute spin bike class led by a qualified instructor.
|
|
Placebo Comparator: No exercise (control)
|
30 minute completing seated activities (e.g., wordsearches)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline state anxiety
Time Frame: In the immediate 10 minutes after the end of the intervention
|
State subscale of the State-Trait Anxiety Inventory (STAI-S).
The State-Trait Anxiety Inventory (STAI) measures both state and trait anxiety in adults; it can be used to distinguish whether individuals are experiencing anxiety.
Trait anxiety refers to the participant's disposition to anxiety, whereas state anxiety measures the current anxiousness of participants and is more labile.
STAI is a questionnaire consisting of forty self-report items.
Subjects are asked to rate the intensities of anxious feelings on a four-point scale: not at all, somewhat, moderately so or very much so.
Scores range from twenty to eighty, where higher scores correlate with higher state or trait anxiety.
|
In the immediate 10 minutes after the end of the intervention
|
|
Change from baseline current mood
Time Frame: In the immediate 10 minutes after the end of the intervention
|
Positive and Negative Mood Schedule (PANAS).
This questionnaire contains 20 items consisting of 10 positive and 10 negative emotions.
The participants indicate to what extent they feel each emotion right now on a 5-point Likert Scale of 'very slightly =1 or not at all' to 'Extremely= 5'.
Adding up the total positive and negative scores will produce overall positive and negative mood scores.
|
In the immediate 10 minutes after the end of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline depressive aspects of mood
Time Frame: In the immediate 10 minutes after the end of the intervention
|
Immediate Mood Scaler (IMS).
This questionnaire contains 22 items developed to assess dynamic components of mood.
Participants are asked to rate their current mood state on a continuum using 7-point Likert scales (e.g., happy-sad, distracted-focused, sleepy-alert).
For each item, an integer score between 1 and 7 is derived.
The total score for this scale is the sum of the scores on all 22 items, where a higher score is indicative of better mood.
|
In the immediate 10 minutes after the end of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline blood pressure
Time Frame: In the immediate 10 minutes after the end of the intervention
|
In the immediate 10 minutes after the end of the intervention
|
|
|
Change from baseline temperature
Time Frame: In the immediate 10 minutes after the end of the intervention
|
In the immediate 10 minutes after the end of the intervention
|
|
|
Change from baseline heart rate
Time Frame: approx. 1 hour in total
|
Measured by a chest strap heart rate monitor
|
approx. 1 hour in total
|
|
Change from baseline stress appraisal of intervention
Time Frame: In the immediate 10 minutes after the end of the intervention
|
The stress appraisal questionnaire captures 1) perceived situational and personal demands, and 2) personal resources. To the extent that perceived demands outweigh resources then individuals are anticipated to be in a "threat" state, whereas when resources outweigh demands individuals are expected to be in a "challenge" state. A questionnaire is given pre-task that captures stress appraisals after knowledge of the task is obtained but before the task itself. There is a post-task questionnaire that assesses individuals' perceptions of the demands and resources after the task. |
In the immediate 10 minutes after the end of the intervention
|
Collaborators and Investigators
Sponsor
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
- 2022-133-KB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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