COPD Clinical Trial
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.
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:
1. 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.
2. 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.
3. Dyspnea. This was measured using the 5-point Medical Research Council (MRC) rating.
4. 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.
5. 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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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