NCT01577329

Brief Summary

The purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

April 11, 2012

Results QC Date

November 22, 2016

Last Update Submit

April 21, 2017

Conditions

Keywords

meditationChronic Obstructive Pulmonary DiseaseMindfulnessAnxietyBreathing Patterns

Outcome Measures

Primary Outcomes (1)

  • Changes in Respiratory Rate

    Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.

    baseline and at week eight

Study Arms (2)

mindfulness meditation class

EXPERIMENTAL

Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.

Behavioral: Mindfulness meditation

wait list

NO INTERVENTION

Subjects assigned to the control group will continue with medical treatment as usual and be allowed to attend the mindfulness meditation class after week eight.

Interventions

Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.

mindfulness meditation class

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any stage of Chronic Obstructive Pulmonary Disease
  • Able to read and write English

You may not qualify if:

  • Severe mental disability
  • Inability to attend

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Chan RR, Giardino N, Larson JL. A pilot study: mindfulness meditation intervention in COPD. Int J Chron Obstruct Pulmon Dis. 2015 Mar 2;10:445-54. doi: 10.2147/COPD.S73864. eCollection 2015.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAnxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Roxane Raffin Chan
Organization
University of Michigan

Study Officials

  • Roxane R Chan, RN, PhD (c)

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 13, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2013

Study Completion

July 1, 2015

Last Updated

August 2, 2017

Results First Posted

August 2, 2017

Record last verified: 2017-04

Locations