Affective and Cognitive Responses to Acute Bouts of Physical Activity and Mindfulness Training

Sedentary Behavior Clinical Trial

Official title:

Affective and Cognitive Responses to Acute Bouts of Aerobic Exercise, Mindfulness Meditation, and Combined Exercise and Meditation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078464
• Other study ID #: STU00210138
• Status: Completed
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: October 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

Other:
• Mindfulness Training Alone
Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.
• Acute Physical Activity Alone
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 Together
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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 minutes
Primary	Response of blood pressure (mm/Hg) to mindfulness training.	Blood pressure will be measured manually every 4 minutes during the intervention	36 minutes
Primary	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.	36 minutes
Primary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes
Secondary	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.	36 minutes