The Effects of Exercise Intensity on Mood and Wellbeing

Sponsor

University of Reading (Other)

Overall Status

Recruiting

CT.gov ID

NCT05721521

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Exercise Mood	Other: Spin Bike Exercise Other: Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

The Effects of Exercise Intensity on Mood and Wellbeing

Actual Study Start Date :

Nov 3, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High intensity	Other: Spin Bike Exercise 30 minute spin bike class led by a qualified instructor.
Experimental: Moderate intensity	Other: Spin Bike Exercise 30 minute spin bike class led by a qualified instructor.
Experimental: Low intensity	Other: Spin Bike Exercise 30 minute spin bike class led by a qualified instructor.
Placebo Comparator: No exercise (control)	Other: Control 30 minute completing seated activities (e.g., wordsearches)

Outcome Measures

Primary Outcome Measures

Change from baseline state anxiety [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.
Change from baseline current mood [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.

Secondary Outcome Measures

Change from baseline depressive aspects of mood [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.

Other Outcome Measures

Change from baseline blood pressure [In the immediate 10 minutes after the end of the intervention]
Change from baseline temperature [In the immediate 10 minutes after the end of the intervention]
Change from baseline heart rate [approx. 1 hour in total]
Measured by a chest strap heart rate monitor
Change from baseline stress appraisal of intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Reading	Reading	Berkshire	United Kingdom

Sponsors and Collaborators

University of Reading

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katie Barfoot, Principal Investigator, University of Reading

ClinicalTrials.gov Identifier:

NCT05721521

Other Study ID Numbers:

2022-133-KB

First Posted:

Feb 10, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2023