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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721521
Other study ID # 2022-133-KB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2022
Est. completion date June 1, 2023

Study information

Verified date December 2023
Source University of Reading
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will adopt a between-within group design where participants will exercise at 1 of 4 intensities for 30 minutes at SportsPark Reading. Mood, mental health (e.g., state anxiety and immediate depressive feelings) and physiological parameters (heart rate, blood pressure and body temperature) will be assessed before and after exercise intervention to compare the acute change across time for each intensity condition (no exercise (control), low, moderate, high).


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Spin Bike Exercise
30 minute spin bike class led by a qualified instructor.
Control
30 minute completing seated activities (e.g., wordsearches)

Locations

Country Name City State
United Kingdom University of Reading Reading Berkshire

Sponsors (1)

Lead Sponsor Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline blood pressure In the immediate 10 minutes after the end of the intervention
Other Change from baseline temperature In the immediate 10 minutes after the end of the intervention
Other Change from baseline heart rate Measured by a chest strap heart rate monitor approx. 1 hour in total
Other Change from baseline stress appraisal of 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
Primary Change from baseline state anxiety 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
Primary Change from baseline current mood 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 Change from baseline depressive aspects of mood 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
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