Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- The six-minute walk test (6MWT)
Study Overview
Brief Summary
The aim of this study is to evaluate the efficacy of a long-term domiciliary exercise program using the Wii video game platform as a training modality in Cystic Fibrosis (CF) patients. Investigators hypothesize that an exercise program performed by active videogames (AVG) will produce an improvement in exercise tolerance and muscular strength to be maintained over time in young CF patients.
Detailed Description
This is a randomized and longitudinal trial. Participants will be randomize in 2 groups: control group (CG) and experimental group (EG), by the ©GrapfPad Software, Inc. The CG will carry out their routine patient management, and the EG will perform also a domiciliary Pulmonary Rehabilitation program of 30-60 min exercise, 5 days/week during 6 weeks using a Nintendo WiiTM platform with the game EA SPORTS ACTIVE 2.
Before and after we will measure:
- exercise tolerance using the six minutes walk test (6MWT) and the modified shuttle walk test (MSWT);
- muscular strength using horizontal jump test (HJT), medicine ball throw (MBT) and handgrip strength (right hand (HGR); left hand (HGL)); and
- HRQoL using the 3 versions of the Cystic Fibrosis Questionnaire-Revised (CFQ-R 6-11, CFQ-R 14+, CFQ-R Parents).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with diagnosis of CF, clinically stable without exacerbations of the disease in the previous 6 weeks to the inclusion date.
Exclusion Criteria
- •To present clinical evidence of cardiovascular, neuromuscular or osteo-articular comorbidities that limit the participation in exercise programs.
- •Lung transplant candidates and those patients that followed any kind of rehabilitation program 12 months before the study.
Arms & Interventions
Nintendo Wii exercise program group
The EG will perform a domiciliary Pulmonary Rehabilitation program of 30-60 min exercise, 5 days/week during 6 weeks using a Nintendo Wii platform with the game EA SPORTS ACTIVE 2. The exercise activities were loaded into each participant´s console during the clinical interview and adjusting the exercises according to their age in 2 groups (>12 years and <13 years). The program consisted of 6 different workouts (1st and 2nd weeks: legs exercises; 3rd week: upper limb exercises; 4th week: thorax exercises; 5th and 6th weeks: cardio exercises), so the patients had a gradual increase reaching the maximum load at the end of training.
Intervention: Nintendo Wii exercise program (Other)
Control group
The CG carried out their routine patient management
Outcomes
Primary Outcomes
The six-minute walk test (6MWT)
Time Frame: Change from Baseline in the 6-min walk distance at 6 weeks and at 12 months of follow up period
The six-minute walk test (6MWT) will perform following the American Thoracic Society recommendations. It is a valid and reliable test in CF children. After recorded basal measurements, patients will be asked to walk as much as possible and standardized encouragement will be given after each minute. Two tests will be performed and the highest walking distance will be recorded.
The modified shuttle walk test (MSWT)
Time Frame: Change from Baseline in the modified shuttle walk distance at 6 weeks and at 12 months of follow up period
The modified shuttle walk test (MSWT): consisted of 15 levels in which patients should walk quickly, gradually increasing speed on a 10 meters space. An external audio signal indicates a level shift. Two tests were performed with 30 minutes of rest and the highest walking distance was recorded (MSWD). Valid and reliable test to measure exercise tolerance in CF.
Secondary Outcomes
- Horizontal jump test (HJT)(Change from Baseline in the horizontal jump distance at 6 weeks and at 12 months of follow up period)
- Medicine ball throw (MBT)(Change from Baseline in the throw distance at 6 weeks and at 12 months of follow up period)
- Handgrip strength (HG)(Change from Baseline in handgrip isometric strength at 6 weeks and at 12 months of follow up period)
Investigators
Tamara del Corral Núñez-Flores
Msc
Universidad Autonoma de Madrid