Cystic FibrosisNCT02552043
Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
A study testing Nintendo Wii exercise program in people with Cystic Fibrosis, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nintendo Wii exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with diagnosis of CF, clinically stable without exacerbations of the disease in the previous 6 weeks to the inclusion date.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro Superior de estudios Universitarios La SALLE
Aravaca, Madrid, 28023
About this study
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.
Read the 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).
- Conditions
- Cystic Fibrosis
- Being tested
- Nintendo Wii exercise program
- Keywords
- Cystic fibrosis, Exercise capacity, Interactive gaming console, Pulmonary rehabilitation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii exercise programOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nintendo Wii exercise program |
| Control group | No intervention | The CG carried out their routine patient management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Change from Baseline in the horizontal jump distance at 6 weeks and at 12 months of follow up period
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.
Measured: Change from Baseline in the throw distance at 6 weeks and at 12 months of follow up period
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.
Measured: Change from Baseline in handgrip isometric strength at 6 weeks and at 12 months of follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara del Corral Núñez-Flores, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552043
- Sponsor's protocol ID
- UAMadrid
- Status last verified
- Aug 2016
- First submitted
- 15 Sep 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Game Exercise Effectiveness of a Domiciliary Pulmonary Rehabilitation Program in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02552043
- Acronym / sponsor ID
- UAMadrid
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Exercise capacity, Interactive gaming console, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii exercise program group | Experimental | Other: Nintendo Wii exercise programThe 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. |
| Control group | No intervention | –The CG carried out their routine patient management |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with diagnosis of CF, clinically stable without exacerbations of the disease in the previous 6 weeks to the inclusion date.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintendo Wii exercise programThe 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 | Other | Nintendo Wii exercise program group |
Primary outcome
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.
3 secondary outcomes
Horizontal jump test (HJT)
Time frame: Change from Baseline in the horizontal jump distance at 6 weeks and at 12 months of follow up period
Medicine ball throw (MBT)
Time frame: Change from Baseline in the throw distance at 6 weeks and at 12 months of follow up period
Handgrip strength (HG)
Time frame: Change from Baseline in handgrip isometric strength at 6 weeks and at 12 months of follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii exercise program in people with Cystic Fibrosis, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.