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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nintendo Wii exercise program
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Exercise capacity, Interactive gaming console, Pulmonary rehabilitation

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Superior de estudios Universitarios La SALLE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nintendo Wii exercise program group

Control group

Arm Description

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.

The CG carried out their routine patient management

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Horizontal jump test (HJT)
Horizontal jump test (HJT): was made with feet placed at shoulder height. Jump would be invalid if they give an extra step and if they are unbalanced and touch the floor with their hands. Three jumps were made and the highest distance in centimetres was recorded. Horizontal jump assessment is has shown reliable to evaluate the power of the legs.
Medicine ball throw (MBT)
Medicine ball throw (MBT): was performed sitting on their knees before throwing the medicine ball (<12 years 2kg; >13 years 3kg) forward like a chest pass with both hands. The furthest distance of the three throws was recorded, with a 1-2 minutes rest between each throw. This instrument is valid and reliable for kindergarten children.
Handgrip strength (HG)
Handgrip strength will be calculate using a Hand Dynamometer (Jamar® hydraulic USA) of 90Kg. Three trails will given for each hand separately with 30s rest between them and the highest value was recorded in kg (right hand (HGR); left hand (HGL)). The subject is placed sitting with the dynamometer in an angle of 90°. This device is valid and reliable to measure isometric strength and anaerobic endurance.

Full Information

First Posted
September 15, 2015
Last Updated
August 20, 2016
Sponsor
Universidad Autonoma de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02552043
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis, Exercise capacity, Interactive gaming console, Pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nintendo Wii exercise program group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The CG carried out their routine patient management
Intervention Type
Other
Intervention Name(s)
Nintendo Wii exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
The six-minute walk test (6MWT)
Description
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.
Time Frame
Change from Baseline in the 6-min walk distance at 6 weeks and at 12 months of follow up period
Title
The modified shuttle walk test (MSWT)
Description
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.
Time Frame
Change from Baseline in the modified shuttle walk distance at 6 weeks and at 12 months of follow up period
Secondary Outcome Measure Information:
Title
Horizontal jump test (HJT)
Description
Horizontal jump test (HJT): was made with feet placed at shoulder height. Jump would be invalid if they give an extra step and if they are unbalanced and touch the floor with their hands. Three jumps were made and the highest distance in centimetres was recorded. Horizontal jump assessment is has shown reliable to evaluate the power of the legs.
Time Frame
Change from Baseline in the horizontal jump distance at 6 weeks and at 12 months of follow up period
Title
Medicine ball throw (MBT)
Description
Medicine ball throw (MBT): was performed sitting on their knees before throwing the medicine ball (<12 years 2kg; >13 years 3kg) forward like a chest pass with both hands. The furthest distance of the three throws was recorded, with a 1-2 minutes rest between each throw. This instrument is valid and reliable for kindergarten children.
Time Frame
Change from Baseline in the throw distance at 6 weeks and at 12 months of follow up period
Title
Handgrip strength (HG)
Description
Handgrip strength will be calculate using a Hand Dynamometer (Jamar® hydraulic USA) of 90Kg. Three trails will given for each hand separately with 30s rest between them and the highest value was recorded in kg (right hand (HGR); left hand (HGL)). The subject is placed sitting with the dynamometer in an angle of 90°. This device is valid and reliable to measure isometric strength and anaerobic endurance.
Time Frame
Change from Baseline in handgrip isometric strength at 6 weeks and at 12 months of follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centro Superior de estudios Universitarios La SALLE
City
Aravaca
State/Province
Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

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

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