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

NCT02552043 | Completed DMC

• 1 other identifier: UAMadrid
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Exercise capacity; Interactive gaming console; Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

• The six-minute walk test (6MWT)

  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.

  Change from Baseline in the 6-min walk distance at 6 weeks and at 12 months of follow up period

• The modified shuttle walk test (MSWT)

  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.

  Change from Baseline in the modified shuttle walk distance at 6 weeks and at 12 months of follow up period

Secondary Outcomes (3)

• 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

Study Arms (2)

Nintendo Wii exercise program group

EXPERIMENTAL

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.

Other: Nintendo Wii exercise program

Control group

NO INTERVENTION

The CG carried out their routine patient management

Interventions

Nintendo Wii exercise program 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

Nintendo Wii exercise program group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

Centro Superior de estudios Universitarios La SALLE

Aravaca, Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 16, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

ES (1)