Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000329965
Ethics application status
Approved
Date submitted
27/03/2011
Date registered
29/03/2011
Date last updated
29/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the effects of aquatic and non-aquatic physiotherapy treatment on postural control among women suffering from osteoporosis: a randomized controlled study
Scientific title
Aquatic or non-aquatic physiotherapy treatment are effective among women suffering from osteoporosis on postural control?
Secondary ID [1] 259865 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 265447 0
Postural control 265448 0
Functional balance 265449 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265608 265608 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will carry out aquatic or non-aquatic physiotherapy treatment. They will perform physiotherapy treatment two days per week for 12 weeks, 60 minutes each session supervised by a physiotherapist. They will be divided into three small groups according to their own schedule preferences. Aquatic physiotherapy training consist about stretching exercise, aerobic exercise as anterior, posterior and lateral walking. After that, participants will perform different ludic exercises to muscle strength and balance with balls, pool bars, aqua noodles, kick boards and floats. Patient lying supine on a pool bar or aqua noodles, legs alternate into flexion and extension, adduction and abduction. Session will finish with a cool-down period.
Intervention code [1] 264286 0
Prevention
Intervention code [2] 264287 0
Rehabilitation
Comparator / control treatment
Non-aquatic physiotherapy treatment will be control arm in this field. The participants will also perform non-aquatic physiotherapy treatment two days per week for 12 weeks, 60 minutes each session supervised by a physiotherapist. They will be divided into three small groups according to their own schedule preferences. Each non-aquatic physiotherapy session will consist of stretching exercises, 4 ankle and knee muscle strengthening exercises at an intensity of 60-70% of 1 repetition maximum (2 sets of 10 repetitions ) and balance training. Static balance training will be performed through simple and double-tasks at stand on one leg, their heels and their tiptoes and tandem position. Dynamic balance training will be performed through lower support base walking. It will be included ludic activities looking for great adherence. Each session will be accompanied by music.
Control group
Active

Outcomes
Primary outcome [1] 262393 0
Posturographic analyzes will be assessed using a stable force platform BERTEC CORPORATION. The variables related to COP (center of pressure) will be area oscillation, antero-posterior (AP) and medio-lateral (ML) displacement amplitude, AP and ML displacement velocity, AP and ML oscillation frequency in bipodal stance, unipodal stance an tandem position.
Timepoint [1] 262393 0
at baseline,12 weeks after randomization and 12 weeks after the end of intervention
Secondary outcome [1] 273692 0
Functional balance will be assessed through Timed Up e Go Test and Berg Balance Scale.
Timepoint [1] 273692 0
at baseline,12 weeks after randomization and 12 weeks after the end of intervention

Eligibility
Key inclusion criteria
community-dwelling women suffering from osteoporosis, 65 years old or older,
Minimum age
65 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants that use some walking aid; present low scores at Mini-Mental State Examination (Bertolucci et al, 1994); or present a doctor report with orthopedics, cardiologic and neurologic impairments or other medical diseases with possible contra-indication of exercise and/or pool therapy.

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)
Randomization was carried out through sealed envelope. Each woman chose between two sealed envelopes that designated her for the groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3316 0
Brazil
State/province [1] 3316 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 264742 0
Charities/Societies/Foundations
Name [1] 264742 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 264742 0
Brazil
Primary sponsor type
Individual
Name
Guilherme de Paula Marinho Nonato
Address
Physical Therapy department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country
Brazil
Secondary sponsor category [1] 263866 0
Individual
Name [1] 263866 0
Mariana Chaves Aveiro
Address [1] 263866 0
Health Science Department
Federal University of Sao Paulo
Avenida Ana Costa, 95
Santos/SP - Brazil
CEP:11060-001
Country [1] 263866 0
Brazil
Secondary sponsor category [2] 263867 0
Individual
Name [2] 263867 0
Patricia Driusso
Address [2] 263867 0
Physical Therapy department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country [2] 263867 0
Brazil
Other collaborator category [1] 251897 0
Individual
Name [1] 251897 0
Andrea Santa Barbara Ceccatto
Address [1] 251897 0
Physical Therapy department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country [1] 251897 0
Brazil
Other collaborator category [2] 251898 0
Individual
Name [2] 251898 0
Jorge Oishi
Address [2] 251898 0
Statistics department
Federal University of Sao Carlos
Via Washington Luis, km 235
Sao Carlos/SP - Brazil
CEP: 13565-905
Country [2] 251898 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266728 0
Comite de Etica em Pesquisa em Seres Humanos
Ethics committee address [1] 266728 0
Universidade Federal de Sao Carlos
Pro-Reitoria de Pos-graduacao e Pesquisa
Via Washington Luis, Km 235
Sao Carlos/SP
CEP: 13560-970
Ethics committee country [1] 266728 0
Brazil
Date submitted for ethics approval [1] 266728 0
Approval date [1] 266728 0
23/04/2008
Ethics approval number [1] 266728 0
0023.0.135.000-08

Summary
Brief summary
The primary purpose of this study is compare the efficacy of aquatic exercise and non-aquatic physiotherapy treatment among elderly women suffering osteoporosis. The study hypothesis consists that women that take part in the aquatic physiotherapy treatment may improve postural control as non-aquatic physiotherapy treatment;however, aquatic treatment has significantly less adverse effects compared to non-aquatic treatment, as risk of falls.
with a land-based programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32394 0
Address 32394 0
Country 32394 0
Phone 32394 0
Fax 32394 0
Email 32394 0
Contact person for public queries
Name 15641 0
Mariana Chaves Aveiro
Address 15641 0
Health Science Department
Federal University of Sao Paulo
Avenue Ana Costa, 95
Santos/SP
CEP: 11060-001
Country 15641 0
Brazil
Phone 15641 0
+55 13 81177212
Fax 15641 0
Email 15641 0
[email protected]
Contact person for scientific queries
Name 6569 0
Mariana Chaves Aveiro
Address 6569 0
Health Science Department
Federal University of Sao Paulo
Avenue Ana Costa, 95
Santos/SP
CEP: 11060-001
Country 6569 0
Brazil
Phone 6569 0
+55 13 81177212
Fax 6569 0
Email 6569 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
EmbaseWater- versus land-based treatment for postural control in postmenopausal osteoporotic women: a randomized, controlled trial.2017https://dx.doi.org/10.1080/13697137.2017.1325460
N.B. These documents automatically identified may not have been verified by the study sponsor.