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Trial registered on ANZCTR


Registration number
ACTRN12612000301864
Ethics application status
Approved
Date submitted
13/03/2012
Date registered
16/03/2012
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults - Randomized Controlled Trial
Scientific title
Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults - Randomized Controlled Trial
Secondary ID [1] 280030 0
Nil known
Secondary ID [2] 288784 0
Nil known
Secondary ID [3] 288785 0
Nil known
Universal Trial Number (UTN)
U1111-1127-9522
Trial acronym
ProBalance
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance 285939 0
Functional mobility 285940 0
Gait 285941 0
Fear of falling 285942 0
Health related quality of life 285944 0
Fall prevention 285945 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286131 286131 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the baseline assessment (of all studied variables/outcomes), the experimental group will receive a multidimensional rehabilitation nursing intervention.
Intervention includes a multiple risk approach, namely, an exercice program (tailored for older adults with moderate to high risk for falling) and an educational component addressing fall prevention and home hazards at the beginning of the intervention period. Rehabilitation sessions will have 90minutes duration, 2 days per week, during 12 weeks. It will include: (1) multisensory training (approaching visual, somatosensory and vestibular systems); (2) center of gravity control Training; (3) proactive and reactive postural strategy training; (4) gait pattern enhancement and variation training; and (5) strengthing and flexibility training.
The intervention will be administered on a group basis by one trained rehabilitation specialist nurse.
Note that the participants of the initial pilot study (http://www.anzctr.org.au/ACTRN12611001164987.aspx) will not be included in this randomised controlled trial.
Intervention code [1] 284351 0
Rehabilitation
Intervention code [2] 284352 0
Treatment: Other
Intervention code [3] 284353 0
Prevention
Comparator / control treatment
Waiting list control group. The control group will receive no intervention, only assessments and standard/usual care. After the end of the trial, the intervention will also be available for the control group, because of ethical issues.
Control group
Active

Outcomes
Primary outcome [1] 286606 0
Balance Measured: FAB Scale score (Rose, 2010).
Timepoint [1] 286606 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [1] 296249 0
Strength (Upper and lower body) Measured: 30 second chair stand, arm curl (Rikli & Jones, 2001).
Timepoint [1] 296249 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [2] 296250 0
Gait parameters Measured: 30-foot walk - Gait stability ratio, gait velocity, cadence (Rose, 2010).
Timepoint [2] 296250 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [3] 296251 0
Functional mobility Measured: 8 Foot Up and Go (Rikli & Jones, 2001).
Timepoint [3] 296251 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [4] 296252 0
Home environment modification Measured: Questionnaire based on Lord, Sherrington, Menz & Close (2007).
Timepoint [4] 296252 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [5] 296253 0
Fear of falling Measured: Falls Efficacy Scale [FES] - Portuguese version, questionnaire (Melo, 2011).
Timepoint [5] 296253 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [6] 296254 0
Health related quality of life Measured: SF-36 - Portuguese version (Ribeiro, 2005).
Timepoint [6] 296254 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [7] 296255 0
Number of fallers (self-reported by the participant, through diary and telefone contact established by the research team)
Timepoint [7] 296255 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.
Secondary outcome [8] 296256 0
Total number of falls (number of events, self-reported by the participant, through diary and telefone contact established by the research team)
Timepoint [8] 296256 0
After the 12 week intervention.
After follow-up - 12 weeks after the intervention finish.

Eligibility
Key inclusion criteria
Community-dwelling older adults;
FAB score higher than 25/40 and equal or lower than 30/40;
FAB score betwen 20 and 25/40, if not reporting falls in the last year;
Able to walk independently.
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment (assessed by the MMST).
Significant co-morbidities that would preclude participation (acute illness, progressive neurological disease, stroke, unstable chronic conditions, etc.)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertisement will be done in the community, using posters, and the media, and dessiminating writting information in social institutions and social networks. The volunteers will be received in the project's laboratory and the assessments on inclusion and exclusion criteria will be done, after informed consent.
After the first selection of those with inclusion criteria, participants will be randomized and allocated to the groups, and the baseline assessments will be done. A simple randomization process, using computer random number generator, will be used to allocate the participants to one of the two similar groups (1. treatment and 2. control group). Clusters will be considered in the randomization for couples and relatives.
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.
This procedure will be done and recorded by an independent person, who is not part of the project's research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Numbers will be randomly selected to form group 1 and group 2, using a random number generator software.
This procedure will be done and recorded by an independent person, who is not part of the project's research team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/03/2012
Actual
29/03/2012
Date of last participant enrolment
Anticipated
Actual
29/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
52
Recruitment outside Australia
Country [1] 4172 0
Portugal
State/province [1] 4172 0
Madeira Island

Funding & Sponsors
Funding source category [1] 284824 0
Self funded/Unfunded
Name [1] 284824 0
Bruna Raquel Gouveia
Country [1] 284824 0
Portugal
Funding source category [2] 284825 0
Charities/Societies/Foundations
Name [2] 284825 0
ARDITI - Agência Regional para o Desenvolvimento da Investigação, Tecnologia e Inovação
Country [2] 284825 0
Portugal
Funding source category [3] 284826 0
University
Name [3] 284826 0
Universidade da Madeira
Country [3] 284826 0
Portugal
Funding source category [4] 293148 0
Other Collaborative groups
Name [4] 293148 0
European Science Foundation Research Networking Programme ‘REFLECTION’
Country [4] 293148 0
United Kingdom
Primary sponsor type
Individual
Name
Bruna Raquel Gouveia
Address
Escola Superior de Enfermagem São José de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country
Portugal
Secondary sponsor category [1] 283705 0
University
Name [1] 283705 0
University of Porto - ICBAS
Address [1] 283705 0
Largo Prof. Abel Salazar, 2
4099-033 Porto
Country [1] 283705 0
Portugal
Other collaborator category [1] 260599 0
Individual
Name [1] 260599 0
Maria Helena Jardim
Address [1] 260599 0
Universidade da Madeira
Centro de Competencia Tecnologias da Saude
Campus Universitario da Penteada
9020-105 Funchal
Madeira
Country [1] 260599 0
Portugal
Other collaborator category [2] 260600 0
Individual
Name [2] 260600 0
Maria Manuela Martins
Address [2] 260600 0
Escola Superior de Enfermagem do Porto
Rua Dr. Antonio Bernardino de Almeida
4200-072 Porto
Country [2] 260600 0
Portugal
Other collaborator category [3] 260601 0
Individual
Name [3] 260601 0
Debra Rose
Address [3] 260601 0
California State University,Fullerton
800 N. State College Blvd.
Fullerton, CA
92831-3599
Country [3] 260601 0
United States of America
Other collaborator category [4] 278895 0
Individual
Name [4] 278895 0
Élvio Rúbio Gouveia
Address [4] 278895 0
University of Madeira
Country [4] 278895 0
Portugal
Other collaborator category [5] 278896 0
Individual
Name [5] 278896 0
Duarte Luís de Freitas
Address [5] 278896 0
University of Madeira
Country [5] 278896 0
Portugal
Other collaborator category [6] 278897 0
Individual
Name [6] 278897 0
José António Maia
Address [6] 278897 0
University of Porto
Country [6] 278897 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286816 0
Comissao de etica para a Saude do Servico de Saude da Regiao Autonoma da Madeira (Ethics commitee of the Health System of the Autonumous Region of Madeira)
Ethics committee address [1] 286816 0
Ethics committee country [1] 286816 0
Portugal
Date submitted for ethics approval [1] 286816 0
Approval date [1] 286816 0
17/01/2011
Ethics approval number [1] 286816 0
1/06/2011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33834 0
Prof Bruna Raquel Gouveia
Address 33834 0
Universidade da Madeira Centro de Competencia Tecnologias da Saude Campus Universitario da Penteada 9020-105 Funchal Madeira
Country 33834 0
Portugal
Phone 33834 0
+351291743444
Fax 33834 0
Email 33834 0
[email protected]
Contact person for public queries
Name 17081 0
Bruna Raquel Gouveia
Address 17081 0
Escola Superior de Enfermagem São José de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country 17081 0
Portugal
Phone 17081 0
+351291743444
Fax 17081 0
Email 17081 0
[email protected]
Contact person for scientific queries
Name 8009 0
Bruna Raquel Gouveia
Address 8009 0
Escola Superior de Enfermagem São José de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country 8009 0
Portugal
Phone 8009 0
+351291743444
Fax 8009 0
Email 8009 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
SourceTitleYear of PublicationDOI
EmbaseAn evaluation of a nurse-led rehabilitation programme (the ProBalance Programme) to improve balance and reduce fall risk of community-dwelling older people: A randomised controlled trial.2016https://dx.doi.org/10.1016/j.ijnurstu.2015.12.004
EmbaseThe effect of the ProBalance Programme on health-related quality of life of community-dwelling older adults: A randomised controlled trial.2018https://dx.doi.org/10.1016/j.archger.2017.08.012
N.B. These documents automatically identified may not have been verified by the study sponsor.