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Trial registered on ANZCTR


Registration number
ACTRN12611001164987
Ethics application status
Approved
Date submitted
5/11/2011
Date registered
8/11/2011
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ProBalance Project - Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults
PILOT STUDY
Scientific title
Prehabilitation and Rehabilitation Nursing: Balance/ fall risk in the community-dwelling older adults - Randomized Controlled Trial
PILOT STUDY
Secondary ID [1] 273125 0
Nil
Universal Trial Number (UTN)
U1111-1124-6982
Trial acronym
ProBalance
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall Prevention 270877 0
Balance 270878 0
Functional Mobility 270879 0
Gait 270880 0
Fear of Falling (Falls Efficacy) 270881 0
Health related Quality of Life 270883 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279056 279056 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the preliminary evaluation, 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 risk for falling) and an educational component addressing fall prevention and home hazards at the beginning of the intervention period.
Rehabilitation sessions will have 1 hour duration, 3 days per week, during 4 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.
Intervention code [1] 269467 0
Rehabilitation
Intervention code [2] 269516 0
Treatment: Other
Intervention code [3] 283627 0
Prevention
Comparator / control treatment
Waiting list control group.
The control group will receive no intervention, only and assessments and standard 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] 279765 0
Balance
Measured: FAB Scale score (Rose, 2010).
Timepoint [1] 279765 0
After 1 month of the intervention.
Secondary outcome [1] 294455 0
Strength (Upper and lower body)
Measured: 30 second chair stand, arm curl (Rikli & Jones, 2001).
Timepoint [1] 294455 0
After 1 month of the intervention.
Secondary outcome [2] 294456 0
Gait parameters
Measured: 30-foot walk - Gait stability ratio, gait velocity, cadence (Rose, 2010).
Timepoint [2] 294456 0
After 1 month of the intervention.
Secondary outcome [3] 294457 0
Functional mobility
Measured: 8 Foot Up and Go (Rikli & Jones, 2001).
Timepoint [3] 294457 0
After 1 month of the intervention.
Secondary outcome [4] 294458 0
Home environment modification
Measured: Questionnaire based on Lord, Sherrington, Menz & Close (2007).
Timepoint [4] 294458 0
After 1 month of intervention
Secondary outcome [5] 294459 0
Fear of falling
Measured: FES - Portuguese version (Melo, 2011).
Timepoint [5] 294459 0
After 1 month of the intervention.
Secondary outcome [6] 294597 0
Health related quality of life
Measured: SF-36 - Portuguese version (Ribeiro, 2005).
Timepoint [6] 294597 0
After 1 month of the intervention.
Secondary outcome [7] 294686 0
Number of fallers
(reported)
Timepoint [7] 294686 0
After 1 month of the intervention.

Eligibility
Key inclusion criteria
Community-dwelling older adults;
Report at least one fall in the last year, or no falls, if FAB score equal or lower than 30/40;
Able to walk independently.
Minimum age
65 Years
Maximum age
80 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 will be used to allocate the participants to one of the two similar groups (1. treatment and 2. control group).
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 coin toss.
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
This is a "mini-RCT" that consists on a pilot study for the development of a larger scale RCT.
This pilot study has specific objectives, mainly, testing procedures and estimate recruiment and sample size.
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] 3872 0
Portugal
State/province [1] 3872 0
Madeira Island

Funding & Sponsors
Funding source category [1] 270044 0
Self funded/Unfunded
Name [1] 270044 0
Bruna Raquel Gouveia
Address [1] 270044 0
Rampa de Quinta de Sant' Ana nº 22
9050-535 Funchal
Madeira
Country [1] 270044 0
Portugal
Funding source category [2] 270045 0
Charities/Societies/Foundations
Name [2] 270045 0
ARDITI - Agencia Regional para o Desenvolvimento da Investigacao, Tecnologia e Inovacao
Address [2] 270045 0
Edif. Madeira Tecnopolo, Piso 2
Caminho da Penteada
9020-105 Funchal
Country [2] 270045 0
Portugal
Funding source category [3] 270046 0
University
Name [3] 270046 0
University of Madeira
Address [3] 270046 0
Colegio dos Jesuitas - Rua dos Ferreiros
9000-082 Funchal
Madeira
Country [3] 270046 0
Portugal
Funding source category [4] 293149 0
Other
Name [4] 293149 0
European Science Foundation Research Networking Programme ‘REFLECTION’
Address [4] 293149 0
University of Exeter Medical School
South Cloisters
St Luke’s Campus
Exeter EX1 2LU
United Kingdom
Country [4] 293149 0
United Kingdom
Primary sponsor type
Individual
Name
Bruna Raquel Gouveia
Address
Escola Superior de Enfermagem Sao Jose de Cluny
Rampa de Quinta de Sant' Ana nº 22
9050-535 Funchal
Madeira
Country
Portugal
Secondary sponsor category [1] 269015 0
University
Name [1] 269015 0
University of Porto - ICBAS
Address [1] 269015 0
Largo Prof. Abel Salazar, 2
4099-033 Porto
Country [1] 269015 0
Portugal
Other collaborator category [1] 252299 0
Individual
Name [1] 252299 0
Maria Helena Jardim
Address [1] 252299 0
Universidade da Madeira
Centro de Competencia Tecnologias da Saude
Campus Universitario da Penteada
9020-105 Funchal
Madeira
Country [1] 252299 0
Portugal
Other collaborator category [2] 252300 0
Individual
Name [2] 252300 0
Maria Manuela Martins
Address [2] 252300 0
Escola Superior de Enfermagem do Porto
Rua Dr. Antonio Bernardino de Almeida
4200-072 Porto
Country [2] 252300 0
Portugal
Other collaborator category [3] 252301 0
Individual
Name [3] 252301 0
Debra Rose
Address [3] 252301 0
California State University,Fullerton
800 N. State College Blvd.
Fullerton, CA
92831-3599
Country [3] 252301 0
United States of America
Other collaborator category [4] 278898 0
Individual
Name [4] 278898 0
Elvio Rubio Gouveia
Address [4] 278898 0
Universidade da Madeira
Departamento de Educacao Fisica e Desporto
Campus Universitario da Penteada
9020-105 Funchal
Madeira
Country [4] 278898 0
Portugal
Other collaborator category [5] 278899 0
Individual
Name [5] 278899 0
Duarte Luis de Freitas
Address [5] 278899 0
Universidade da Madeira
Departamento de Educacao Fisica e Desporto
Campus Universitario da Penteada
9020-105 Funchal
Madeira
Country [5] 278899 0
Portugal
Other collaborator category [6] 278900 0
Individual
Name [6] 278900 0
Jose Antonio Maia
Address [6] 278900 0
Faculdade de Desporto da Universidade do Porto
Rua Dr. Placido Costa, 91
4200-450 Porto
Country [6] 278900 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272000 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] 272000 0
Hospital Dr. Nelio Mendonca
Avenida Luis de Camoes
9004-154
Funchal
Madeira
Ethics committee country [1] 272000 0
Portugal
Date submitted for ethics approval [1] 272000 0
07/01/2011
Approval date [1] 272000 0
17/01/2011
Ethics approval number [1] 272000 0
1/06/2011

Summary
Brief summary
This project incorporates a pilot study of a larger scale 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 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;
(2) 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; 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 6 month follow up.
The pilot study consists in a "mini-RCT", with one month duration and a sample of 20 participants, aimed at testing procedures, and estimating recruitment, retention and sample size for the larger RCT.
Trial website
Trial related presentations / publications
Presentations:

Gouveia, B.R., Jardim, H., Rose, D.J. (2011). - 11th Iberoamerican Conference on Nursing Education of the ALADEFE and to the 3rd Latin American-European Meeting - Oral Communication: “Prehabilitation and rehabilitation nursing: Balance/fall risk in community-dwelling older adults”.

Gouveia, B.R., Jardim, H., Martins, M.M. (2011). - 11th Iberoamerican Conference on Nursing Education of the ALADEFE and to the 3rd Latin American-European Meeting -Communication/Poster: “Foundation of gerontological rehabilitation nursing: applicability of the functional consequences theory”.

Publications:

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 33211 0
Prof Bruna Raquel Gouveia
Address 33211 0
Escola Superior de Enfermagem Sao Jose de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country 33211 0
Portugal
Phone 33211 0
+351291743444
Fax 33211 0
Email 33211 0
bgouveia@esesjcluny.pt
Contact person for public queries
Name 16458 0
Prof Bruna Raquel Gouveia
Address 16458 0
Escola Superior de Enfermagem Sao Jose de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country 16458 0
Portugal
Phone 16458 0
+351291743444
Fax 16458 0
Email 16458 0
bgouveia@esesjcluny.pt
Contact person for scientific queries
Name 7386 0
Prof Bruna Raquel Gouveia
Address 7386 0
Escola Superior de Enfermagem Sao Jose de Cluny
Rampa de Quinta de Sant' Ana, 22.
9050-535 Funchal - Portugal
Country 7386 0
Portugal
Phone 7386 0
+351 924065152
Fax 7386 0
Email 7386 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