NCT04078464

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

December 9, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

August 20, 2019

Last Update Submit

December 6, 2019

Conditions

Keywords

MindfulnessPhysical Activity

Outcome Measures

Primary Outcomes (4)

  • 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

  • Response of blood pressure (mm/Hg) to mindfulness training.

    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).

    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).

    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 Outcomes (8)

  • Intervention effect on mindfulness as measured by the State Mindfulness Scale

    36 minutes

  • Intervention effect on affect as measured by the Positive and Negative Affect Schedule (PANAS).

    36 minutes

  • Intervention effect on anxiety will be assessed using the State Trait Anxiety Inventory (STAI)

    36 minutes

  • Intervention effect on cognition as measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker)

    36 minutes

  • Intervention effect on cognition as measured by NIH Toolbox List Sorting Working Memory Test.

    36 minutes

  • +3 more secondary outcomes

Study Arms (3)

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.

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.

Other: Mindfulness Training Alone

Acute Physical Activity

EXPERIMENTAL

20 minutes of walking on a treadmill at a moderate pace.

Other: Acute Physical Activity Alone

Interventions

Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.

Mindfulness training

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

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.

Acute Physical Activity + Mindfulness training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in spoken and written English
  • Have access to internet to complete baseline and post-study assessments

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The order the participants participate in the 3 experimental conditions will be randomly assigned.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2019

First Posted

September 6, 2019

Study Start

August 26, 2019

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

December 9, 2019

Record last verified: 2019-10

Locations