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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 284824 0
Escola Superior de Enfermagem São José de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
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
Address [2] 284825 0
Edif. Madeira Tecnopolo, Piso 2
Caminho da Penteada
9020-105 Funchal
Portugal
Country [2] 284825 0
Portugal
Funding source category [3] 284826 0
University
Name [3] 284826 0
Universidade da Madeira
Address [3] 284826 0
Colégio dos Jesuítas - Rua dos Ferreiros
9000-082 Funchal - Portugal
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’
Address [4] 293148 0
Europe
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
Hospital Dr. Nelio Mendonca
Avenida Luis de Camoes
9004-154
Funchal
Madeira
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
This project incorporates a randomized controlled trial aimed to:
(1) Investigate of the effect of a gerontological rehabilitation nursing program in a group of community-dwelling elderly, living in Madeira, Portugal, on balance (FAB Scale scores), muscular strength (30 second chair stand, arm curl), functional mobility (8 Foot Up and Go), gait parameters (30-foot walk), health related quality of life (SF-36 - Portuguese version, Ribeiro (2005)), fear of falling (FES – Portuguese version, Melo (2011)), home environment (based on Lord, Sherrington, Menz & Close; 2007), and number of falls (number of fallers and falls rate), when compared to a control group.
(2) Describe the relationship between potential confounders and balance/incidence of falls in older adults involved in the rehabilitation program, when compared to a control group.
This research is based on three hypotheses: (1) A rehabilitation nursing program designed to approach balance and mobility, as well as multiple risk factors, can improve balance in a group of older-adults, when compared to the control group, after a 3 month duration intervention and during follow up;
(2) A rehabilitation nursing program designed to approach balance and mobility, as well as multiple risk factors, can reduce the risk of falling in a group of older-adults, when compared to the control group, after a 3 month duration intervention and during follow up; and
(3) The group of older-adults involved in a specific rehabilitation program present higher levels of balance/lower risk for falling, higher levels of strength and functional mobility, better results in gait parameters, higher levels of health related quality of life (SF-36 - Portuguese version, Ribeiro (2005)), reduced fear of falling (FES – Portuguese version, Melo (2011)), and less risk factors in home environment, when compared with the older-adults included in the control group, after a 3 month intervention and 3 month follow up.
An initial pilot study was developed before this trial. Further information on the pilot study is available in the ANZCTR link: http://www.anzctr.org.au/ACTRN12611001164987.aspx.
Trial website
Trial related presentations / publications
Presentations:

Gouveia, BR; Jardim, H; Martins, MM; Gouveia, ER., Freitas, DL., Maia, JA., Rose, DJ. (2014). Impact Of The ProBalance Program On Balance In Community-dwelling Older Adults From Madeira Island, Portugal. 61th Annual Meeting and 5th World Congress on Exercise is Medicine of the ACSM. Florida, USA.


Gouveia, BR; Jardim, H.; Martins, M; & Rose, DJ. (2014). ProBalance – Uma intervenção multidimensional centrada na promoção da funcionalidade do idoso - Seminário Dimensões físicas do Envelhecimento e Exercício – 1º ciclo de EDFD, 28 de Fevereiro de 2014, Funchal, Madeira.

Gouveia, BR; Jardim, H.; Martins, M; Gouveia ER; Freitas DL; Maia JÁ; Rose D (2013). Equilíbrio e risco de cair em adultos idosos residentes na comunidade, na Região Autónoma da Madeira. II Colóquio Olhares sobre o Envelhecimento, 14 e 15 de Novembro 2013, Universidade da Madeira, Funchal, Madeira.

Gouveia, BR; Jardim, H.; Martins, M; & Rose, DJ. (2013). Apresentação do Projeto de Investigação Probalance - Seminário de Envelhecimento e Saúde – 1º ciclo de EDFD, 17 de Abril de 2013, Funchal, Madeira.

Gouveia, BR; Jardim, H; Martins, M; Gouveia, ER. (2013). O perfil do adulto-idoso aderente a um programa de intervenção para melhorar o equilíbrio e prevenir quedas - Congresso Internacional Género(s) e Saúde: (In)Determinações e Aproximações, Coimbra, Portugal.

Gouveia, BR; Jardim, H; Martins, M; Gouveia, ER; Rose, DJ. (2013). ProBalance - Preabilitação e Enfermagem de Reabilitação: Equilíbro/risco de queda em adultos-idosos residentes na comunidade - Ensaio Clínico Controlado Randomizado - V Congresso Envelhecimento(s): a Arte de Viver, 3 e 4 de Outubro, Ponta Delgada Açores.

Gouveia BR; Jardim H; Martins M; Gouveia ER; Freitas DL; Maia JÁ; Rose D. (2012). Balance and fall risk in community-dwelling older adults from Madeira, Portugal. The 8th World Congress on Active Ageing. 14 a 17 de Agosto, Glasgow, Scotland.

Gouveia, BR; Jardim, H.; Martins, M; & Rose, DJ. (2012). Apresentação do Projeto de Investigação Probalance, Workshop Envelhecer na actualidade… Que desafios?, 1 de Outubro de 2012, Ordem dos Enfermeiros – Secção Regional da Madeira, Funchal, Madeira.

Gouveia, BR; Jardim, H.; Martins, M; Gouveia ER; Rose D (2012). ProBalance - Preabilitação e Enfermagem de Reabilitação: Equilíbro/risco de queda em adultos-idosos residentes na comunidade – Ensaio Clínico Controlado Randomizado. Colóquio Olhares sobre o Envelhecimento, 11 e 12 de Outubro 2012, Universidade da Madeira, Funchal, Madeira.

Publications:

Gouveia, BR; Jardim, H; Martins, MM; Gouveia, ER., Freitas, DL., Maia, JA., Rose, DJ. (2015). An 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. Int. J. Nurs. Stud. http://dx.doi.org/10.1016/j.ijnurstu.2015.12.004

Gouveia, BR; Jardim, H; Martins, MM; Gouveia, ER., Freitas, DL., Maia, JA., Rose, DJ. (2014). Impact Of The ProBalance Program On Balance In Community-dwelling Older Adults From Madeira Island, Portugal. Medicine & Science in Sports & Exercise, 46 (5), S105.

Gouveia, BR; Jardim, H; Martins, M. (2013). Cinesioterapia em Reabilitação Gerontológica: uma análise da literatura. Referência, 11, 133-142.

Gouveia, BR; Jardim, H; Martins, M; Gouveia, ER. (2013). O perfil do adulto-idoso aderente a um programa de intervenção para melhorar o equilíbrio e prevenir quedas, Referência. [Suppl],10 (3). p.130.

Gouveia BR; Jardim H; Martins M; Gouveia ER; Freitas DL; Maia JÁ; Rose D. (2012). Balance and fall risk in community-dwelling older adults from Madeira, Portugal. Journal of Aging and Physical Activity. 20. S1 – S369.

Gouveia B, Jardim H, Martins M, Fernandes D, Silva B, Vieira L, Bettencourt R, Quintal C, Pinto A, Rodrigues R, Gouveia ER. (2012). O perfil do idoso que cai: Um estudo de caracterização em idosos residentes na comunidade. Livro de Atas do Seminário Internacional de Desporto e Ciência, Universidade da Madeira, 2 a 3 de Março (in press).

Gouveia, B.R., Jardim, H., & Rose, D.J. (2011). Prehabilitation and rehabilitation nursing: Balance/fall risk in community-dwelling older adults. Referencia [Suppl], 2(4). p.432.

Gouveia, B.R., Jardim, H., Martins, M.M. (2011). Foundation of gerontological rehabilitation nursing: applicability of the functional consequences theory . Referencia [Suppl], 1(4). p.475.
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
bgouveia@esesjcluny.pt
Contact person for public queries
Name 17081 0
Prof 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
bgouveia@esesjcluny.pt
Contact person for scientific queries
Name 8009 0
Prof 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
bgouveia@esesjcluny.pt

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary