Clinical trial NCT02552043: Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
Official title: Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Exercise capacity
Interactive gaming console
Pulmonary rehabilitation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 41
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. exercise tolerance using the six minutes walk test (6MWT) and the modified shuttle walk test (MSWT);
2. muscular strength using horizontal jump test (HJT), medicine ball throw (MBT) and handgrip strength (right hand (HGR); left hand (HGL)); and
3. HRQoL using the 3 versions of the Cystic Fibrosis Questionnaire-Revised (CFQ-R 6-11, CFQ-R 14+, CFQ-R Parents).

Eligibility criteria: 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.

Primary outcomes:
measure: The six-minute walk test (6MWT)
timeFrame: Change from Baseline in the 6-min walk distance at 6 weeks and at 12 months of follow up period
measure: The modified shuttle walk test (MSWT)
timeFrame: Change from Baseline in the modified shuttle walk distance at 6 weeks and at 12 months of follow up period
Secondary outcomes:
measure: Horizontal jump test (HJT)
timeFrame: Change from Baseline in the horizontal jump distance at 6 weeks and at 12 months of follow up period
measure: Medicine ball throw (MBT)
timeFrame: Change from Baseline in the throw distance at 6 weeks and at 12 months of follow up period
measure: Handgrip strength (HG)
timeFrame: Change from Baseline in handgrip isometric strength at 6 weeks and at 12 months of follow up period
Other outcomes:
Locations:
city: Aravaca
country: Spain
facility: Centro Superior de estudios Universitarios La SALLE
state: Madrid
Study officials:
References: