COPDNCT01539421
Use of Wii Home Computer in Patients With Chronic Obstructive Pulmonary Disease: Effects on Quality of Life
A study testing Use of Home exercise computer program in people with COPD, run by Trinity Health Of New England at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Use of Home exercise computer program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St Francis Hospital and Medical center
Hartford, Connecticut, 06105
About this study
Official title: The Use of Home Exercise Program Based on Interactive Entertainment Computer System in Patients With Moderate to Severe COPD: Its Feasibility and Effects on Exercise Performance, Physical Activity, Dyspnea, and Quality of Life
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.
Read the detailed description
After an initial clinical assessment, which included spirometry or review of recent spirometric data, patients performed an ISWT, as described above. Those who required using supplemental oxygen carried their own tanks. For those who had participated in the pilot study, another ISWT was performed at this time.
Following a 1-hour rest period, baseline outcome assessments were obtained. These included:
- The Endurance Shuttle Walk Test (ESWT) 9 After an initial warm-up at a slow walk speed, patients walked at an external pace set by an audio source at approximately 85% of their maximal determined by the ISWT. Time at this speed was recorded.
- Health status. This was measured using the self-reported Chronic Respiratory Questionnaire (CRQ-SR) which has domains of dyspnea, fatigue, emotion and mastery as well as a total score.
- Dyspnea. This was measured using the 5-point Medical Research Council (MRC) rating.
- The number of sit-to-stand repetitions in 30 seconds. The patient was seated on a chair without arms and instructed to stand up (without using his/her arms) and then return to the seated position as many times as possible in a 30-second period. This test was first demonstrated by an investigator and then performed by the patient.
- The number of arm lift repetitions in 60 seconds.11 The subject was instructed to stand and repetitively raise a wooden dowel, from a position resting against the thighs, up to eye level with the arms straight at the elbows, and the return to original position. The maximum number of completed repetitions in 60 s was recorded.
Patients returned after a 6 week non-intervention period when the above-listed outcomes were repeated. They were then given instructions on how to use the Wii Fit unit to perform exercise at home and instructed to perform at least 30 minutes of specified exercises on most days of the week. The required exercises, in sequence, were 1) "Basic Run" (warm up exercise); 2) "Bird's Eye, Bull's-Eye" (mostly upper arm exercise); 3) "Free Step" (mostly lower extremity exercise); 4) "Obstacle Course" (upper and lower extremity exercise); and 5) "Basic Run" (cool down exercise). Additional, ad-lib exercises using this device were allowed. They were instructed to maintain a diary, recording the dates of each session and the total number of minutes devoted to this exercise. Other exercises not based on this system were allowed but not recorded.
- Conditions
- COPD
- Being tested
- Use of Home exercise computer program
- Keywords
- COPD, exercise endurance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Home exercise computer programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Use of Wii computer for enhanced exercise in COPD patients. Receives: Behavioral: Use of Home exercise computer program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption (VO2) during Wii Exercise
Measured: 30 minutes per day
Secondary outcomes (1)
Gender Differences in ESWT performance
Measurement comparisons between males and females at baseline, 6 weeks non-intervention, 6 weeks intervention, 12 weeks intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Richard ZuWallack, MD, Principal investigator, WVU Medicine Thomas Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539421
- Sponsor's protocol ID
- 10-06-007
- Status last verified
- Feb 2012
- First submitted
- 21 Feb 2012
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Home Exercise Program Based on Interactive Entertainment Computer System in Patients With Moderate to Severe COPD: Its Feasibility and Effects on Exercise Performance, Physical Activity, Dyspnea, and Quality of Life
- ClinicalTrials.gov ID
- NCT01539421
- Acronym / sponsor ID
- 10-06-007
- Conditions
- COPD
- Keywords
- COPD, exercise endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After an initial clinical assessment, which included spirometry or review of recent spirometric data, patients performed an ISWT, as described above. Those who required using supplemental oxygen carried their own tanks. For those who had participated in the pilot study, another ISWT was performed at this time.
Following a 1-hour rest period, baseline outcome assessments were obtained. These included:
- The Endurance Shuttle Walk Test (ESWT) 9 After an initial warm-up at a slow walk speed, patients walked at an external pace set by an audio source at approximately 85% of their maximal determined by the ISWT. Time at this speed was recorded.
- Health status. This was measured using the self-reported Chronic Respiratory Questionnaire (CRQ-SR) which has domains of dyspnea, fatigue, emotion and mastery as well as a total score.
- Dyspnea. This was measured using the 5-point Medical Research Council (MRC) rating.
- The number of sit-to-stand repetitions in 30 seconds. The patient was seated on a chair without arms and instructed to stand up (without using his/her arms) and then return to the seated position as many times as possible in a 30-second period. This test was first demonstrated by an investigator and then performed by the patient.
- The number of arm lift repetitions in 60 seconds.11 The subject was instructed to stand and repetitively raise a wooden dowel, from a position resting against the thighs, up to eye level with the arms straight at the elbows, and the return to original position. The maximum number of completed repetitions in 60 s was recorded.
Patients returned after a 6 week non-intervention period when the above-listed outcomes were repeated. They were then given instructions on how to use the Wii Fit unit to perform exercise at home and instructed to perform at least 30 minutes of specified exercises on most days of the week. The required exercises, in sequence, were 1) "Basic Run" (warm up exercise); 2) "Bird's Eye, Bull's-Eye" (mostly upper arm exercise); 3) "Free Step" (mostly lower extremity exercise); 4) "Obstacle Course" (upper and lower extremity exercise); and 5) "Basic Run" (cool down exercise). Additional, ad-lib exercises using this device were allowed. They were instructed to maintain a diary, recording the dates of each session and the total number of minutes devoted to this exercise. Other exercises not based on this system were allowed but not recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Use of Home exercise computer programUse of Wii computer for enhanced exercise in COPD patients. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Home exercise computer programAfter 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. | Behavioural | Exercise Intervention |
Primary outcome
Oxygen Consumption (VO2) during Wii Exercise
Time frame: 30 minutes per day
1 secondary outcome
Gender Differences in ESWT performance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard ZuWallack, MD principal investigator
WVU Medicine Thomas Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Home exercise computer program in people with COPD, run by Trinity Health Of New England at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Consumption (VO2) during Wii Exercise (time frame: 30 minutes per day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.