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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Experimental: Mindfulness training
Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 20 minutes.
Other: Mindfulness Training Alone
Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.
Experimental: Acute Physical Activity
20 minutes of walking on a treadmill at a moderate pace.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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
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.
36 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
36 minutes
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.
36 minutes
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.
36 minutes
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.
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.
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.
36 minutes
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.
36 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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  • 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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