HealthyNCT05721521
The Effects of Exercise Intensity on Mood and Wellbeing
A study testing Spin Bike Exercise in people with Healthy and Exercise, run by University of Reading at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Spin Bike Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Spin Bike Exercise, Control
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spin Bike ExerciseOther
30 minute spin bike class led by a qualified instructor.
ControlOther
30 minute completing seated activities (e.g., wordsearches)
| Study group | Role | What they receive |
|---|---|---|
| High intensity | Experimental | Not described Receives: Other: Spin Bike Exercise |
| Moderate intensity | Experimental | Not described Receives: Other: Spin Bike Exercise |
| Low intensity | Experimental | Not described Receives: Other: Spin Bike Exercise |
| No exercise (control) | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the immediate 10 minutes after the end of the intervention
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.
Measured: In the immediate 10 minutes after the end of the intervention
Secondary outcomes (1)
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.
Measured: In the immediate 10 minutes after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start3 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Barfoot, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721521
- Sponsor's protocol ID
- 2022-133-KB
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Intensity on Mood and Wellbeing
- ClinicalTrials.gov ID
- NCT05721521
- Acronym / sponsor ID
- 2022-133-KB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity | Experimental | Other: Spin Bike Exercise |
| Moderate intensity | Experimental | Other: Spin Bike Exercise |
| Low intensity | Experimental | Other: Spin Bike Exercise |
| No exercise (control) | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-30 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spin Bike Exercise30 minute spin bike class led by a qualified instructor. | Other | High intensity, Low intensity, Moderate intensity |
| Control30 minute completing seated activities (e.g., wordsearches) | Other | No exercise (control) |
Primary outcome
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.
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.
1 secondary outcome
Change from baseline depressive aspects of mood
Time frame: In the immediate 10 minutes after the end of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spin Bike Exercise in people with Healthy and Exercise, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline state anxiety (time frame: In the immediate 10 minutes after the end of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.