CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 325 enrolled
Drug / intervention
Physical activity self-management +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01108991
NCT01108991N/ACompleted

Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

The University of Texas Health Science Center at Tyler·interventional·Posted Apr 22, 2010·Updated Dec 29, 2015

In Brief

A clinical study evaluating Physical activity self-management and COPD education + Usual care for Chronic Obstructive Pulmonary Disease. Completed, enrolled 325 participants across 1 site.

Detailed Summary

Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire \[CRQ\] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2010
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.2 years ago

Interventions

Physical activity self-managementbehavioral

This intervention includes a manual, telephone health coach calls, and automated telephone calls. The manual has 20 chapters for the active phase and 5 maintenance phase chapters. During the first 20 weeks the health coach will call patients every other week and the automated telephone calls will occur on the alternate weeks.

COPD education + Usual careother

Six weeks of COPD self-management education plus usual care