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NCT01654289 · ClinicalTrials.gov registry record · Phase 2

University of Wisconsin Meditation & Exercise Cold Study

A Phase 2 study of Acute Respiratory Infection, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 2
Development phase
413
Enrollment target
1
Study location

NCT01654289: Completed Phase 2 study of Acute Respiratory Infection, sponsored by University of Wisconsin, Madison.

NCT01654289 is a Phase 2 study of Acute Respiratory Infection that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 413 participants, above the 272-participant average among 7 other Acute Respiratory Infection trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01654289, a Phase 2 study of Acute Respiratory Infection, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
413 participants
Enrollment target
1
Study location

Study Summary

The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise will lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza like illness. Specifically, this project aims to: 1. Determine whether an 8-week training program in mindfulness meditation, as compared to the control group, will lead to significant reductions in incidence, duration, and severity of ARI illness. 2. Determine whether an 8-week training program in moderate intensity sustained exercise, as compared to the control group, will lead to reductions in incidence, duration, and severity of ARI illness. 3. Assess whether any observed reductions in ARI illness are accompanied by fewer ARI-related health care visits and less time lost to productive work (reduced absenteeism). 4. Compare the potential benefits of mindfulness meditation to those from moderate intensity sustained exercise. 5. Discern potential mediating factors and causal pathways that might help explain how these interventions lead to improved ARI illness-related outcomes. The investigators' preliminary findings suggest substantial benefit of these interventions in terms of reduced incidence, duration and severity of ARI illness, with corresponding reductions in days of work lost to illness. If the proposed research confirms these findings, there will be major implications for public and private health-related policy and practice, as well as for scientific knowledge regarding health maintenance and disease prevention.

Primary Outcome

The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.

Interventions

  • OTHER Exercise
  • OTHER Mindfulness Meditation

Study Locations (1)

Wisconsin

  • University of Wisconsin Department of Family Medicine - Madison

Trial Details

FieldValue
Enrollment Target 413 participants
Start Date 2012-07
Est. Completion 2016-06
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT01654289 record still lists

NCT01654289 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, above the 272-participant average among 7 other Acute Respiratory Infection trials with a reported enrollment target (52% higher).

The record links to 1 condition, with Acute Respiratory Infection appearing as the primary indexed condition, and to 2 interventions - of which Exercise is the first listed.

NCT01654289 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01654289 about?

NCT01654289 is a clinical study titled "University of Wisconsin Meditation & Exercise Cold Study". The primary goal of this project is to determine whether behavioral training in mindfulness meditation or moderate intensity sustained exercise will lead to reductions in acute respiratory infection (ARI) illness, such as common cold and influenza like illness. Specifically, this project aims to: 1...

What is the current status of trial NCT01654289?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 413 participants. The study started on 2012-07. Estimated completion is 2016-06.

What conditions does trial NCT01654289 study?

This clinical trial studies the following conditions: Acute Respiratory Infection.

What interventions are being tested in trial NCT01654289?

The interventions under investigation include: Exercise (OTHER), Mindfulness Meditation (OTHER).

Who is sponsoring clinical trial NCT01654289?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01654289 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01654289, the US trial registry maintained by the National Library of Medicine. NCT01654289 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.