NCT01539421

Brief Summary

This study was designed to evaluate the effectiveness of 12 weeks' home exercise training using the Nintendo ® Wii Fit system in patients with COPD. Following an initial pilot study at one institution to determine the physiological responses to exercise training using the home based interactive computer system, a longitudinal study was performed to evaluate outcomes across several areas. Outcomes were measured at baseline, after 6 weeks of standard care, and after 6 and 12 weeks of home exercise training. Three hospital based pulmonary rehabilitation centers in Connecticut participated in the longitudinal study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

1.1 years

First QC Date

February 21, 2012

Last Update Submit

February 27, 2012

Conditions

Keywords

COPDexercise endurance

Outcome Measures

Primary Outcomes (1)

  • Oxygen Consumption (VO2) during Wii Exercise

    30 minutes per day

Secondary Outcomes (1)

  • Gender Differences in ESWT performance

    12 weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Use of Wii computer for enhanced exercise in COPD patients.

Behavioral: Use of Home exercise computer program

Interventions

After a 30-minute rest period the study patient performed a series of 4 representative exercises from the Wii under direct supervision by an investigator. Five minutes' rest was allotted between each exercise. The patient was instructed to exercise at his/her own pace, with a maximal duration of 5 minutes per exercise. The Oxycon Mobile was worn throughout this exercise, and the metabolic measurements listed above were recorded over the last 30 seconds of each exercise. The exercises included running in place, upper arm movements, stepping in place, and obstacle course.

Exercise Intervention

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent (Approval by the St. Francis Hospital IRB will be required before study initiation)
  • Adults, age \> 40 years
  • A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator FEV1/FVC \< 0.70
  • Moderate, severe and very severe airflow limitation by GOLD criteria.
  • Clinically stable respiratory disease
  • The perceived ability to participate in pulmonary testing and exercise testing
  • COPD, stable state

You may not qualify if:

  • Women of childbearing potential
  • Asthma
  • Supplemental oxygen use or anticipated oxygen desaturation \< 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
  • Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
  • An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
  • A history of a prolonged QT interval
  • Recent exacerbation of COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Francis Hospital and Medical center

Hartford, Connecticut, 06105, United States

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

  • Richard ZuWallack, MD

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations