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Trial registered on ANZCTR


Registration number
ACTRN12617001170314
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
9/08/2017
Date last updated
9/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a physiotherapy intervention on functional health of elderly people with reduced physical mobility
Scientific title
Effects of a physiotherapy intervention on functional health of elderly people with reduced physical mobility
Secondary ID [1] 291536 0
None
Universal Trial Number (UTN)
U1111-1194-6849
Trial acronym
EofPIonFHofEPwithRPM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
elderly effects 302858 0
Poor physical mobility 303663 0
balance disorders 303664 0
Condition category
Condition code
Musculoskeletal 302338 302338 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 302339 302339 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study will be in function of "Education for functional health in the elderly with reduced mobility".
To that end, we propose data collection at the level of aerobic capacity, cognitive function, strength, balance and flexibility, and the implementation of an exercise program with the objective of training of anticipatory reaction mechanisms, dual-task and multi-task training "- importance of associated motor and cognitive training to improve functional capacity and decrease the risk of falls.
The independent variable of this study will be the introduction of specific exercises of functional training in the gymnastics class of physical activity program in the elderly, in the one that will be the experimental group.
The program of this study will run for 12 consecutive weeks with sessions 3 times a week and 30 minutes each session. These sessions are performed with the elderly group (small group) of a day care center of the three study locations (Moselos, Lustosa and Tondelinha) included in the physical activity period of the Viseu Active program.
The dependent variables will be the risk of falling, balance, functional and cognitive capacity of the elderly.
The program includes:
• Clarification session where all the information related to the study will be provided, and all doubts will be clarified.
• In the group that will be chosen as experimental (That is, from a single day center - Moselos), education for functional health will be introduced where a new series of functional exercises will be started every 15 days in the five areas of practice (aerobic training, balance, strength, flexibility and cognitive). At the beginning of each new series of exercises (Every 15 days are included a new series of 2 physical exercises and 2 cognitive exercises, this new series will add to the exercises previously applied in the previous series, the five areas of practice listed run simultaneously), the physiotherapist will introduce them and the remaining times will be the responsibility of the local physical activity technician apply the exercises .
Intervention code [1] 297775 0
Lifestyle
Intervention code [2] 298347 0
Treatment: Other
Comparator / control treatment
The group that will remain as a control group, will maintain the physical activity program class in the elderly. This program consists of aerobic exercises of mobility of the upper limbs and lower limbs seated in the chair
Control group
Active

Outcomes
Primary outcome [1] 302249 0
Analysis a musculoskeletal pain assessment in the elderly with reduced physical mobility using questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976) in order to verify and categorize the pain felt (where 0 corresponded to no pain and 5 to the full amount of pain felt by the subject), and its duration (acute pain, subacute or chronic pain).
Timepoint [1] 302249 0
At baseline, after 1 month, after 2 month and after 3 month
Primary outcome [2] 302745 0
Analysis of the intervention of a functional health education program in the elderly with reduced physical mobility according a questionnaire on functional mobility with a composite outcome, assessed by Time Up and Go (person's mobility and requires both static and dynamic balance), Berg balance scale (static and dynamic balance abilities) and FES (Fall Efficacy Scale - fall risk assessment).
Timepoint [2] 302745 0
At baseline, after 1 month, after 2 month and after 3 month
Primary outcome [3] 302746 0
Analysis of the intervention of a functional health education program in the elderly with reduced physical mobility with questionnaire about cognitive performance, assessed by Mini-mental (Cognitive Performance Scale) ,
Timepoint [3] 302746 0
At baseline, after 1 month, after 2 month and after 3 month
Secondary outcome [1] 336016 0
Observation analysis if the recommended functional exercises program was implemented using video analysis
Timepoint [1] 336016 0
three times a weeks during twelve weeks
Secondary outcome [2] 336892 0
Correlation between musculoskeletal pain and functional mobility in the elderly with reduced physical mobility when functional health education program was implemented using questionnaire according to Body Discomfort Scale, Time Up and Go, Berg balance scale and FES (Fall Efficacy Scale).
Timepoint [2] 336892 0
After 1 month, after 2 month and after 3 month of the introduction of the series of functional exercises

Eligibility
Key inclusion criteria
Age plus 65 years old
Physical mobility reduction
Elderly who can not comply with the Initial Assessment of Physical-Functional Fitness according to the Otago Exercise Programme
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample used in the current study was of a non-probabilistic type and chosen by convenience with a small number of participants to better control the variables applied.
The population that will be studied includes individuals of both gender and are enrolled in the physical activity program "Viseu Ativo".
The elderly group analyzed is composed of the participants in the physical activity "Active Viseu" program of these three localities, who attend the day centers of Lustosa, Moselos and Tondelinha, Viseu – Portugal. Of the 44 elderly participants in this program, only 24 completed the questionnaire proposed.
The sample size was defined through the participants enrolled in the program and who agreed to participate in the present study after signed the informed consent term and the study was approved by the Ethical Committee of Piaget Institute. This study follows the recommendations of the Oviedo treaty and the Helsinki Declaration concerning human studies.
The individuals were divided into 2 groups, randomly, the Experimental Group and the Control Group composed of 12 individuals each, integrating them according to the localities.
Data were analysed using a statistical analysis program - Statistical Package for the Social Sciences (SPSS), version 21.0. Wilcoxon test for Non-parametric statistics were used (comparing the same group at different times), setting the level of significance at p = .05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/03/2017
Date of last participant enrolment
Anticipated
Actual
21/04/2017
Date of last data collection
Anticipated
Actual
21/07/2017
Sample size
Target
44
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 8797 0
Portugal
State/province [1] 8797 0
Viseu

Funding & Sponsors
Funding source category [1] 296028 0
University
Name [1] 296028 0
Piaget Institute of Viseu
Country [1] 296028 0
Portugal
Primary sponsor type
University
Name
Piaget Institute of Viseu
Address
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country
Portugal
Secondary sponsor category [1] 294916 0
None
Name [1] 294916 0
None
Address [1] 294916 0
None
Country [1] 294916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297287 0
Ethics Committee of Piaget Institute
Ethics committee address [1] 297287 0
Ethics committee country [1] 297287 0
Portugal
Date submitted for ethics approval [1] 297287 0
01/03/2017
Approval date [1] 297287 0
29/03/2017
Ethics approval number [1] 297287 0

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

Contacts
Principal investigator
Name 73586 0
Prof Gustavo Desouzart
Address 73586 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 73586 0
Portugal
Phone 73586 0
+351911973370
Fax 73586 0
+351 232 910 189
Email 73586 0
[email protected]
Contact person for public queries
Name 73587 0
Gustavo Desouzart
Address 73587 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 73587 0
Portugal
Phone 73587 0
+351911973370
Fax 73587 0
+351 232 910 189
Email 73587 0
[email protected]
Contact person for scientific queries
Name 73588 0
Gustavo Desouzart
Address 73588 0
Campus Universitário de Viseu
Estrada do Alto do Gaio
3515-776 Galifonge, Lordosa – Viseu
Country 73588 0
Portugal
Phone 73588 0
+351911973370
Fax 73588 0
+351 232 910 189
Email 73588 0
[email protected]

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