NCT00373932

Brief Summary

The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

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

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

2.6 years

First QC Date

September 6, 2006

Last Update Submit

December 3, 2009

Conditions

Pulmonary Disease, Chronic ObstructiveCOPDEmphysemaChronic Bronchitis

Keywords

ExercisePhysical ActivityAdherence

Outcome Measures

Primary Outcomes (1)

  • Exercise behavior

    3 & 6 Months

Secondary Outcomes (5)

  • Self-efficacy for exercise

    3 & 6 Months

  • Perception of support

    3 & 6 Months

  • COPD exacerbation

    3 & 6 Months

  • Exercise Performance

    3 & 6 months

  • Health related quality of life

    3 & 6 months

Study Arms (2)

MOBILE-A

EXPERIMENTAL

Coached exercise persistence intervention

Behavioral: Coached exercise persistence intervention

MOBILE-B

ACTIVE COMPARATOR

Self-monitored exercise persistence intervention

Behavioral: Self-Monitored exercise persistence intervention

Interventions

Coached exercise persistence interventionBEHAVIORAL

Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.

MOBILE-A
Self-Monitored exercise persistence interventionBEHAVIORAL

Self-monitoring of symptoms and exercise using a mobile device

MOBILE-B

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe COPD (FEV1/FVC \<70% and FEV1%\<80%)
  • Ability to speak, read and write English
  • Age 40 or older
  • Willingness to complete a 6 month program

You may not qualify if:

  • Illnesses such as bronchiectasis, active malignancies or other end stage diseases
  • Plans to continue in a maintenance program after rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.

    PMID: 22772084DERIVED

  • Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.

    PMID: 19750190DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis, ChronicMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesBehavior

Study Officials

  • Huong Q. Nguyen, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

US(1)