Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000861055
Ethics application status
Approved
Date submitted
13/10/2010
Date registered
14/10/2010
Date last updated
14/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nintendo Wii exercise training in adults with cystic fibrosis
Scientific title
Cardiovascular demand of Nintendo Wii exercise training in adults with cystic fibrosis.
Secondary ID [1] 252854 0
NA
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 258375 0
Condition category
Condition code
Respiratory 258548 258548 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 258569 258569 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single session lasting 15 mins of aerobic exercise training using games of the Nintendo Wii.

The washout period between the 2 exercise training sessions was 24 hours.
Intervention code [1] 257372 0
Rehabilitation
Comparator / control treatment
Single session lasting 15 mins of usual aerobic physiotherapy exercise program involving interval based treadmill or bicycle ergometer exercise
Control group
Active

Outcomes
Primary outcome [1] 259386 0
Cardiovascular demand will be measured using physiological parameters of heart rate and oxygen saturation recorded continuously via a forehead probe with a Nellcor N-20PA Handheld Pulse oximeter.
Timepoint [1] 259386 0
Physiological parameters (heart rate and oxygen saturation) will be measured continuously during 5 mins of rest and 15 min exercise session. Averages and maximum values at rest and for the exercise session will be recorded.
Secondary outcome [1] 265919 0
Energy expenditure (Metabolic equivalents) will be measured using a SenseWear Pro activity monitor (Body Media, Pittsburg, PA).
Timepoint [1] 265919 0
Data willbe recorded continuously during 5 mins of rest and 15 min exercise session. Averages and total energy expended at rest and for the exercise session will be recorded.
Secondary outcome [2] 265955 0
Perception of using both exercise modes will be measured using a visual analogue scale. Perception of enjoyment, levels of fatigue, workload and confidence that an appropriate level of exercise was undertaken will be measured.
Timepoint [2] 265955 0
Perception will be recorded at completion of each exercise session.

Eligibility
Key inclusion criteria
diagnosis of Cystic Fibrosis (CF);
current inpatients but are clinically stable (no temperature, excessive breathlessness, respiratory rate not greater than 25 breaths/minute);
able to communicate in English,
attending physiotherapy gym for exercise program daily as part of routine inpatient management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiovascular conditions prohibiting participation in an exercise program,
systemic disease affecting muscles or joints (e.g. acute arthritis),
recent surgery,
acute musculoskeletal pain requiring physiotherapy intervention, participating in other clinical trials, impaired mental health.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be approached by treating physiotherapist. The study will be explained to them, opportunity will be provided to have questions answered, information sheet will be provided. If screened as suitable to participate and willing to volunteer, participants will sign the consent form. After initial baseline measures participants will be randomly allocated to either experimental or control intervention first. Allocation sequence will be determined by investigator not involved in recruitment or delivery of interventions. Sequence will be put into concealed envelopes which will be opened following recruitement and base line measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer random numbers generator program will be used to determine the sequence that participants are allocated into experimental and control interventions first.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Intention to treat analysis
Concealed allocation
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257823 0
Self funded/Unfunded
Name [1] 257823 0
Country [1] 257823 0
Primary sponsor type
University
Name
Griffith University
Address
School of Physiotherapy and Exercise Science
Griffith University, Gold Coast Campus
Griffith Univeristy QLD 4222
Country
Australia
Secondary sponsor category [1] 257025 0
None
Name [1] 257025 0
Address [1] 257025 0
Country [1] 257025 0
Other collaborator category [1] 251555 0
Hospital
Name [1] 251555 0
The Prince Charles Hospital
Address [1] 251555 0
Rode Road
Chermside QLD 4032
Country [1] 251555 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259853 0
The Prince Charles Hospital Human Ethics Committee
Ethics committee address [1] 259853 0
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Ethics committee country [1] 259853 0
Australia
Date submitted for ethics approval [1] 259853 0
Approval date [1] 259853 0
23/06/2008
Ethics approval number [1] 259853 0

Summary
Brief summary
Cystic fibrosis (CF) is a chronic hereditary disease affecting respiratory and endocrine systems. There is no cure for this disease but treatment advances have seen increases in life
expectancy. Adults with CF have to adhere to a strict life-long regime of self care including chest physiotherapy, antibiotics, vitamins and exercise. Exercise is now a regular treatment tool with benefits including increased respiratory function, fitness and strength. This project seeks to investigate if participating in an exercise program using the recently developed Nintendo Wii is an alternative to a regular exercise program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31758 0
Address 31758 0
Country 31758 0
Phone 31758 0
Fax 31758 0
Email 31758 0
Contact person for public queries
Name 15005 0
Suzanne Kuys
Address 15005 0
Allied Health Research Collaborative
Metro North (Northern) Health Service District
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 15005 0
Australia
Phone 15005 0
61 7 31396319
Fax 15005 0
Email 15005 0
[email protected]
Contact person for scientific queries
Name 5933 0
Suzanne Kuys
Address 5933 0
Allied Health Research Collaborative
Metro North (Northern) HSD
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country 5933 0
Australia
Phone 5933 0
61 7 31396319
Fax 5933 0
Email 5933 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.