NCT03453671

Brief Summary

This study aims to test the effect of three cognitive strategies to affect individuals' subjective experience of cardiovascular exercise. Participants will be randomly assigned to one of three strategies to use while exercising, both during an in-person session and self-directed two week exercise period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 6, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

December 6, 2017

Last Update Submit

October 10, 2018

Conditions

Outcome Measures

Primary Outcomes (5)

  • Affective valence

    Affective valence during a 30-minute exercise bout

    30 minutes

  • Felt arousal

    Felt arousal during a 30-minute exercise bout

    30 minutes

  • Perceived Exertion (RPE)

    Rating of Perceived Exertion during a 30-minute exercise bout

    30 minutes

  • Minutes of exercise

    Minutes exercised during 2-week at-home intervention

    2-weeks following initial visit

  • Affect and perceived exertion: longitudinal

    Rated affect and perceived exertion during 2-week at-home intervention

    2-weeks following initial visit

Secondary Outcomes (6)

  • Theory of Planned Behavior: attitudes

    Baseline to 2-week follow-up

  • Theory of Planned Behavior: norms

    Baseline to 2-week follow-up

  • Theory of Planned Behavior: self-efficacy

    Baseline to 2-week follow-up

  • Theory of Planned Behavior Constructs

    Baseline to 2-week follow-up

  • Distress tolerance

    Baseline to 2-week follow-up

  • +1 more secondary outcomes

Study Arms (3)

Mindfulness

EXPERIMENTAL

Participants will use the strategy of mindfulness, i.e., present moment awareness with nonjudgment and acceptance, while exercising.

Behavioral: Mindfulness

Distraction

EXPERIMENTAL

Participants will use the strategy of distraction, i.e., directing their attention to something other than exercise (specifically a podcast) while exercising.

Behavioral: Distraction

Self-Monitoring

ACTIVE COMPARATOR

Participants will monitor their internal experience while exercising, without distraction and without being taught mindfulness skills of nonjudgment and acceptance.

Behavioral: Self-monitoring

Interventions

MindfulnessBEHAVIORAL

Participants will use mindfulness techniques while exercising

Mindfulness
DistractionBEHAVIORAL

Participants will distract themselves while exercising

Distraction
Self-monitoringBEHAVIORAL

Participants will use associative attentional focus while exercising

Self-Monitoring

Eligibility Criteria

Age18 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIndividuals of all gender identities may participate in this study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 40.
  • Physically capable of safely engaging in moderate-intensity physical activity (PA)
  • Able and willing to access the Internet daily for two weeks
  • Willing to accept random assignment.
  • Have a smartphone or other mobile device (e.g., iPod Touch) that can play media (important if participants are assigned to the distraction condition)
  • Willing to engage in an exercise intervention specifically involving walking, jogging, running, or hiking (not other types of exercise)

You may not qualify if:

  • Are diabetic or receiving treatment for a metabolic disorder
  • Are currently pregnant
  • Are currently on antipsychotic medications
  • Have a history of cardiac or respiratory disease
  • Are receiving treatment for a heart condition or high blood pressure
  • Experience chest pains during and/or not during physical activity
  • Have a muscle, bone, or joint problem or injury that limit movement, make exercise painful, or could be made worse by exercising
  • Have a close family history of an adverse cardiac event before the age of 50.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Innovation and Creativity (CINC)

Boulder, Colorado, 80301, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

MindfulnessOsteogenesis, DistractionBlood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesBone LengtheningOrthopedic ProceduresSurgical Procedures, OperativeBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will know their own condition (strategy) but not what the other conditions are. The primary investigator will be blind to participants' assignment to condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2017

First Posted

March 5, 2018

Study Start

December 15, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations