Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000834358
Ethics application status
Approved
Date submitted
2/02/2017
Date registered
6/06/2017
Date last updated
6/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Falls-risk determining factors encountered among the University of the Third Age students pursuing a specific physical rehabilitation programme.
Scientific title
Falls-risk determining factors encountered among the University of the Third Age students pursuing a specific physical rehabilitation programme.
Secondary ID [1] 290924 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls in elderly 301645 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301351 301351 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-60 women above 60 years old
-30 participants randomly enrolled into intervention group
-30 participants randomly enrolled into control group
-Small group sessions at the study site gym
-Excercise : Aerobic exercises will involve brisk walking, muscle strengthening, flexibility and balance
-the intensity of excersises: 50-70% maximum heart rate
-All sessions will be delivered by a physiotherapist
-45 min/ twice a week/ 6 months,
-All participants in this study are students of the University of third age
-Attendance list on each session
Intervention code [1] 296864 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 300751 0
Balance assesed by Timed up and go
Timepoint [1] 300751 0
6 months after program start
Primary outcome [2] 300752 0
Muscle strength assesed by Senior Fitness Test,
Timepoint [2] 300752 0
6 months after program start
Secondary outcome [1] 330782 0
Falls risk assesed by Timed up and go,
Timepoint [1] 330782 0
6 months after program start
Secondary outcome [2] 332422 0
Possibility of raising after the fall assesed by Simple Rise Test
Timepoint [2] 332422 0
6 months after program start

Eligibility
Key inclusion criteria
Any member of the Jagiellonian University of the third age
Minimum age
60 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injuries or bad health condition such as osteoporosis, heart disease, total hip arthroplasty, total knee artroplasty, rheumatic disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/09/2015
Date of last participant enrolment
Anticipated
Actual
31/05/2016
Date of last data collection
Anticipated
Actual
30/12/2016
Sample size
Target
90
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8573 0
Poland
State/province [1] 8573 0
Malopolska

Funding & Sponsors
Funding source category [1] 295342 0
University
Name [1] 295342 0
Academy of Physical Education
Country [1] 295342 0
Poland
Primary sponsor type
University
Name
Jagiellonian University of third age
Address
31-120 Cracow
Al. Mickiewicza 3
Country
Poland
Secondary sponsor category [1] 294167 0
None
Name [1] 294167 0
Address [1] 294167 0
Country [1] 294167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296799 0
Ethics committee by the district medical chamber
Ethics committee address [1] 296799 0
31-123 Cracow
Krupnicza 11a
Ethics committee country [1] 296799 0
Poland
Date submitted for ethics approval [1] 296799 0
10/02/2014
Approval date [1] 296799 0
08/04/2014
Ethics approval number [1] 296799 0
Nr 22/KBL/OIL/2014

Summary
Brief summary
Falls belong to large geriatric problems and it is estimated that every 3rd person over the age of 65 years, and every 2nd person over the age of 80 years is falling. The consequences of the fall are often very complex. Its effects can be seen in several aspects and in the medical one falls are direct causes of fractures, what leads also to more serious problems.

The purpose of this study is impact assessment of a 6-month rehabilitation program on possibility to stand up after falling, risk of falling and in addition functional health improvement of University of the Third Age students.

The study hypothesis are: the possibility to stand up after falling is more effective in a study group who took part in 6-month rehabilitation program and risk of falling is much lower.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71742 0
Prof Marek Zak
Address 71742 0
University of Physical Education in Cracow
Al. Jana Pawla II 78
31-571 Cracow
Country 71742 0
Poland
Phone 71742 0
+48 12 683 1134
Fax 71742 0
Email 71742 0
mzak1@onet.eu
Contact person for public queries
Name 71743 0
Mr Grzegorz Puzio
Address 71743 0
University of Physical Education in Cracow
Al. Jana Pawla II 78
31-571 Cracow
Country 71743 0
Poland
Phone 71743 0
+48 606 200 069
Fax 71743 0
Email 71743 0
grzegorz.puzio@gmail.com
Contact person for scientific queries
Name 71744 0
Mr Grzegorz Puzio
Address 71744 0
University of Physical Education in Cracow
Al. Jana Pawla II 78
31-571 Cracow
Country 71744 0
Poland
Phone 71744 0
+48 606 200 069
Fax 71744 0
Email 71744 0
grzegorz.puzio@gmail.com

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
No additional documents have been identified.