- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078464
Affective and Cognitive Responses to Acute Bouts of Physical Activity and Mindfulness Training
December 6, 2019 updated by: Siobhan M Phillips, Northwestern University
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Fluent in spoken and written English
- Have access to internet to complete baseline and post-study assessments
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute Physical Activity + Mindfulness training
20 minutes of walking on a treadmill at a moderate pace while listening to a pre-recorded guided mindfulness meditation.
|
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.
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Experimental: Mindfulness training
Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 20 minutes.
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Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.
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Experimental: Acute Physical Activity
20 minutes of walking on a treadmill at a moderate pace.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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36 minutes
|
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
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36 minutes
|
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.
|
36 minutes
|
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.
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36 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention effect on mindfulness as measured by the State Mindfulness Scale
Time Frame: 36 minutes
|
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.
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36 minutes
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Intervention effect on affect as measured by the Positive and Negative Affect Schedule (PANAS).
Time Frame: 36 minutes
|
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.
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36 minutes
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Intervention effect on anxiety will be assessed using the State Trait Anxiety Inventory (STAI)
Time Frame: 36 minutes
|
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.
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36 minutes
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Intervention effect on cognition as measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker)
Time Frame: 36 minutes
|
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.
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36 minutes
|
Intervention effect on cognition as measured by NIH Toolbox List Sorting Working Memory Test.
Time Frame: 36 minutes
|
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.
|
36 minutes
|
Intervention effect on cognition as measured by NIH Toolbox Dimensional Change Card Sort Test.
Time Frame: 36 minutes
|
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.
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36 minutes
|
Intervention effect on cognition as measured by NIH Toolbox Pattern Comparison Processing Speed Test
Time Frame: 36 minutes
|
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.
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36 minutes
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Intervention effect on cognition as measured by NIH Toolbox Picture Sequence Memory Test.
Time Frame: 36 minutes
|
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.
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36 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2019
Primary Completion (Actual)
November 15, 2019
Study Completion (Actual)
November 15, 2019
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 30, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Actual)
December 9, 2019
Last Update Submitted That Met QC Criteria
December 6, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU00210138
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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