NCT01218282

Brief Summary

Exercise training is the key component of respiratory rehabilitation.The success of long-term program resides in the integration between exercise prescription and patients'compliance with home training. This can be difficult for patients, especially in terms of understanding the exercise intensity. This study is designed to evaluate different methods of exercise training at home, to help understanding and maintaining the walking intensity in COPD patients. Outcome: exercise performance, daily physical activity and respiratory function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
Last Updated

October 27, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

October 7, 2010

Last Update Submit

October 26, 2010

Conditions

COPD

Keywords

COPDhome exercise training

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    1 year

Study Arms (3)

Home Exercise Training Group A1

EXPERIMENTAL

Patients assigned to this arm maintain the prescribed walking speed during the training with a metronome

Behavioral: Home exercise training

Home Exercise Training Group A2

EXPERIMENTAL

Patients assigned to this arm cover a fixed distance in a given period of time.

Behavioral: Home exercise training

Control

NO INTERVENTION
Behavioral: NO Exercise Training

Interventions

Home exercise trainingBEHAVIORAL

20-30 min/day for at least 4 days/week

Also known as: Pulmonary Rehabilitation
Home Exercise Training Group A1Home Exercise Training Group A2
NO Exercise TrainingBEHAVIORAL

No intervention

Also known as: No intervention
Control

Eligibility Criteria

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

You may qualify if:

  • COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

You may not qualify if:

  • COPD patients with a recent history of cardiovascular disease and other diseases that would interfere with exercise performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary respiratory unit- University Hospital

Ferrara, Ferrara, 44100, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Annalisa Cogo, MD

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 11, 2010

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2010

Last Updated

October 27, 2010

Record last verified: 2010-10

Locations

IT(1)