NCT01320930

Brief Summary

The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2007

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

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

January 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

March 23, 2011

Status Verified

January 1, 2011

Enrollment Period

4 years

First QC Date

March 22, 2011

Last Update Submit

March 22, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Effect of Pulmonary rehabilitation.Exercise capacityQuality of life

Study Arms (2)

Pulmonary rehabilitation

ACTIVE COMPARATOR

A standardized 7 week rehabilitation program, including physical training and education.

Behavioral: Pulmonary rehabilitation

Control

PLACEBO COMPARATOR

Conventional care

Behavioral: conventional care

Interventions

Pulmonary rehabilitationBEHAVIORAL
Pulmonary rehabilitation
conventional careBEHAVIORAL
Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A diagnosis of moderate COPD.
  • Motivation for Pulmonary rehabilitation.

You may not qualify if:

  • Comorbidity contraindicating rehabilitation.
  • Participation in pulmonary rehabilitation within the last year.
  • Cognitive disorders limiting the ability to participate in physical training and education sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

March 1, 2011

Last Updated

March 23, 2011

Record last verified: 2011-01