Sedentary BehaviorNCT04078464
Affective and Cognitive Responses to Acute Bouts of Physical Activity and Mindfulness Training
A study testing Mindfulness Training Alone, Acute Physical Activity Alone and Acute Physical Activity and Mindfulness Training Together in people with Sedentary Behavior, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the present study is to investigate the benefits of mindfulness training during an acute bout of physical activity. We will compare the combination of mindfulness training and physical activity to mindfulness training alone and physical activity alone in three 20 minute sessions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Mindfulness Training Alone, Acute Physical Activity Alone and Acute Physical Activity and Mindfulness Training Together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 15 Nov 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in spoken and written English
- Have access to internet to complete baseline and post-study assessments
Who cannot join
- Respiratory, joint, or cardiovascular problems precluding physical activity participation
- Fail the Physical Activity Readiness Questionnaire (PAR-Q) and are unable to obtain physician consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affective and Cognitive Responses to Acute Bouts of Aerobic Exercise, Mindfulness Meditation, and Combined Exercise and Meditation
The purpose of the present study is to investigate the benefits of mindfulness training during an acute bout of physical activity. We will compare the combination of mindfulness training and physical activity to mindfulness training alone and physical activity alone in three 20 minute sessions.
Read the detailed description
We will investigate whether mindfulness training during a single bout (20 minutes) of physical activity influences ratings of perceived exertion, feeling states and physiological response (blood pressure and heart rate) during physical activity. Changes in affect and cognitive function pre- and post- physical activity bout will also be assessed. The effects of mindfulness training during an acute bout of physical activity will be compared to mindfulness training alone and acute physical activity alone. This research will contribute to larger questions of how to increase rates of physical activity in the general population and make physical activity more enjoyable.
- Conditions
- Sedentary Behavior
- Being tested
- Mindfulness Training Alone, Acute Physical Activity Alone, Acute Physical Activity and Mindfulness Training Together
- Keywords
- Mindfulness, Physical Activity
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training AloneOther
Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.
Acute Physical Activity AloneOther
Physical activity will include a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.
Acute Physical Activity and Mindfulness Training TogetherOther
Participants will listen to a pre-recorded mindfulness meditation which will guide them through a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.
| Study group | Role | What they receive |
|---|---|---|
| Acute Physical Activity + Mindfulness training | Experimental | 20 minutes of walking on a treadmill at a moderate pace while listening to a pre-recorded guided mindfulness meditation. Receives: Other: Acute Physical Activity and Mindfulness Training Together |
| Mindfulness training | Experimental | Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 20 minutes. Receives: Other: Mindfulness Training Alone |
| Acute Physical Activity | Experimental | 20 minutes of walking on a treadmill at a moderate pace. Receives: Other: Acute Physical Activity Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of heart rate (beats per minute) to mindfulness training.
Heart rate will be measured using a polar heart rate monitor.and will be recorded every minute during the intervention.
Measured: 36 minutes
Response of blood pressure (mm/Hg) to mindfulness training.
Blood pressure will be measured manually every 4 minutes during the intervention
Measured: 36 minutes
Influence of mindfulness training on perceived exertion as measured by the Borg's Rating of Perceived Exertion scale (RPE).
Perceived exertion will be measured using Borg's Rating of Perceived Exertion scale. Participants will be asked how hard they perceive they are working every minute during the intervention on a scale from 6 to 20, with 6 being no work and 20 being working very, very hard.
Measured: 36 minutes
Influence of mindfulness training feeling state as measured by the Feeling Scale (FS).
Participants will be asked to rate how they feel, using the Feeling Scale (FS), every minute during the intervention. The scale ranges from -5 to +5 with -5 being very bad and +5 being very good.
Measured: 36 minutes
Secondary outcomes (8)
Intervention effect on mindfulness as measured by the State Mindfulness Scale
Mindfulness will be assessed using the State Mindfulness Scale, after the intervention, at each study visit. Participants will rate their awareness of physical sensations and mental events (emotions, thoughts) on a scale of 1-5. 1=not at all, 2= a little, 3=somewhat, 4=well, 5=very well. There are 21 items on the scale. A higher score is indicative of greater mindfulness.
Measured: 36 minutes
Intervention effect on affect as measured by the Positive and Negative Affect Schedule (PANAS).
Affect will be measured using the Positive and Negative Affect Schedule (PANAS) before and after the intervention. Participants rate how they have felt this week, in response to words describing feelings, on a scale from 1-5; 1=Very Slightly or Not at all, 2= A Little, 3= Moderately, 4= Quite a bit, 5= Extremely. PANAS is divided into two sub-scales for positive and negative affect. Positive affect scores range from 10-50 with a higher score representing higher levels of positive affect. Negative affect scores also range from 10-50 with lower scores representing lower levels of negative affect.
Measured: 36 minutes
Intervention effect on anxiety will be assessed using the State Trait Anxiety Inventory (STAI)
Anxiety will be measured using the State Trait Anxiety Inventory (STAI) before and after the intervention. Participants will rate how they feel right now, in response to 20 statements about how people may feel, on a scale of 1-4; 1=Not at all, 2= Somewhat, 3=Moderately So, 4= Very much so. Total score ranges between 20 and 80 with 20-37 being no or low anxiety, moderate anxiety=38-44, and high anxiety=45-80.
Measured: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker)
Participants will complete the NIH toolbox Flanker Inhibitory Control and Attention Test on an iPad before and after the intervention. The Flanker test is scored as a combination of the accuracy score and reaction time score. Score range is 0-10 with a higher score indicating a better performance.
Measured: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox List Sorting Working Memory Test.
Participants will complete the NIH Toolbox List Sorting Working Memory Test on an iPad before and after the intervention. The test is scored as the total number of items correctly recalled and sequenced. Score range is 0-26, with a higher score indicating a better performance.
Measured: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Dimensional Change Card Sort Test.
Participants will complete the NIH Toolbox Dimensional Change Card Sort Test on an iPad before and after the intervention. The test is a measure of cognitive flexibility. The test is scored as a combination of the accuracy score and reaction time score. Score range is 0-10 with a higher score indicating a better performance.
Measured: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Pattern Comparison Processing Speed Test
Participants will complete the NIH Toolbox Pattern Comparison Processing Speed Test on an iPad before and after the intervention. The test is scored as the sum of the number of items answered correctly in 90 seconds. Score range is 0-130. Higher scores indicate faster speed of processing.
Measured: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Picture Sequence Memory Test.
Participants will complete the NIH Toolbox Picture Sequence Memory Test before and after the intervention. The Picture Sequence Memory Test measures episodic memory; cognitive processes involved in the acquisition, storage, and retrieval of new information. Participants are given credit for each adjacent pair of pictures they correctly place, up to 17 points. A higher score indicates a better performance.
Measured: 36 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start26 Aug 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The order the participants participate in the 3 experimental conditions will be randomly assigned.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siobhan M Phillips, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078464
- Sponsor's protocol ID
- STU00210138
- Status last verified
- Oct 2019
- First submitted
- 20 Aug 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective and Cognitive Responses to Acute Bouts of Aerobic Exercise, Mindfulness Meditation, and Combined Exercise and Meditation
- ClinicalTrials.gov ID
- NCT04078464
- Acronym / sponsor ID
- STU00210138
- Conditions
- Sedentary Behavior
- Keywords
- Mindfulness, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 6 Sep 2019 (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 purpose of the present study is to investigate the benefits of mindfulness training during an acute bout of physical activity. We will compare the combination of mindfulness training and physical activity to mindfulness training alone and physical activity alone in three 20 minute sessions.
Detailed description
We will investigate whether mindfulness training during a single bout (20 minutes) of physical activity influences ratings of perceived exertion, feeling states and physiological response (blood pressure and heart rate) during physical activity. Changes in affect and cognitive function pre- and post- physical activity bout will also be assessed. The effects of mindfulness training during an acute bout of physical activity will be compared to mindfulness training alone and acute physical activity alone. This research will contribute to larger questions of how to increase rates of physical activity in the general population and make physical activity more enjoyable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The order the participants participate in the 3 experimental conditions will be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Acute Physical Activity + Mindfulness training | Experimental | Other: Acute Physical Activity and Mindfulness Training Together20 minutes of walking on a treadmill at a moderate pace while listening to a pre-recorded guided mindfulness meditation. |
| Mindfulness training | Experimental | Other: Mindfulness Training AloneParticipants will lie down and listen to a pre-recorded guided mindfulness meditation for 20 minutes. |
| Acute Physical Activity | Experimental | Other: Acute Physical Activity Alone20 minutes of walking on a treadmill at a moderate pace. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fluent in spoken and written English
- Have access to internet to complete baseline and post-study assessments
Key exclusion criteria (2 listed)
- Respiratory, joint, or cardiovascular problems precluding physical activity participation
- Fail the Physical Activity Readiness Questionnaire (PAR-Q) and are unable to obtain physician consent to participate
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 |
|---|---|---|
| Mindfulness Training AloneParticipants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes. | Other | Mindfulness training |
| Acute Physical Activity AlonePhysical activity will include a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching. | Other | Acute Physical Activity |
| Acute Physical Activity and Mindfulness Training TogetherParticipants will listen to a pre-recorded mindfulness meditation which will guide them through a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching. | Other | Acute Physical Activity + Mindfulness training |
Primary outcome
Response of heart rate (beats per minute) to mindfulness training.
Time frame: 36 minutes
Heart rate will be measured using a polar heart rate monitor.and will be recorded every minute during the intervention.
Response of blood pressure (mm/Hg) to mindfulness training.
Time frame: 36 minutes
Blood pressure will be measured manually every 4 minutes during the intervention
Influence of mindfulness training on perceived exertion as measured by the Borg's Rating of Perceived Exertion scale (RPE).
Time frame: 36 minutes
Perceived exertion will be measured using Borg's Rating of Perceived Exertion scale. Participants will be asked how hard they perceive they are working every minute during the intervention on a scale from 6 to 20, with 6 being no work and 20 being working very, very hard.
Influence of mindfulness training feeling state as measured by the Feeling Scale (FS).
Time frame: 36 minutes
Participants will be asked to rate how they feel, using the Feeling Scale (FS), every minute during the intervention. The scale ranges from -5 to +5 with -5 being very bad and +5 being very good.
8 secondary outcomes
Intervention effect on mindfulness as measured by the State Mindfulness Scale
Time frame: 36 minutes
Intervention effect on affect as measured by the Positive and Negative Affect Schedule (PANAS).
Time frame: 36 minutes
Intervention effect on anxiety will be assessed using the State Trait Anxiety Inventory (STAI)
Time frame: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker)
Time frame: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox List Sorting Working Memory Test.
Time frame: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Dimensional Change Card Sort Test.
Time frame: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Pattern Comparison Processing Speed Test
Time frame: 36 minutes
Intervention effect on cognition as measured by NIH Toolbox Picture Sequence Memory Test.
Time frame: 36 minutes
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 9 Dec 2019.
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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 Mindfulness Training Alone, Acute Physical Activity Alone and Acute Physical Activity and Mindfulness Training Together in people with Sedentary Behavior, run by Northwestern University at 1 site in United States.
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 2 inclusion and 2 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 9 Dec 2019. 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 States. 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. 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?
Response of heart rate (beats per minute) to mindfulness training. (time frame: 36 minutes). The study lists 4 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 9 Dec 2019.