Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients

NCT ID: NCT02552043

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

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).

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nintendo Wii exercise program

Intervention Type: OTHER

The aerobic training protocol was designed to improve muscular strength, body endurance and flexibility (involved activities as: running, up the knees, butt kickers, etc.). The game used has a strap pouch to hold the Nunchuk© controller placed on the thigh that detects the lower body movements, and also features a number of exercise options supervised by a virtual personal trainer

Control group

The CG carried out their routine patient management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nintendo Wii exercise program

The aerobic training protocol was designed to improve muscular strength, body endurance and flexibility (involved activities as: running, up the knees, butt kickers, etc.). The game used has a strap pouch to hold the Nunchuk© controller placed on the thigh that detects the lower body movements, and also features a number of exercise options supervised by a virtual personal trainer

Intervention Type: OTHER

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Tamara del Corral Núñez-Flores

Msc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Superior de estudios Universitarios La SALLE

Aravaca, Madrid, Spain

Countries

Spain

Other Identifiers

UAMadrid

Identifier Type: -

Identifier Source: org_study_id