Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000457943
Ethics application status
Approved
Date submitted
5/04/2011
Date registered
4/05/2011
Date last updated
5/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of physical therapy in association with dance in healthy elderly
Scientific title
Effectiveness of physical therapy in association with dance in healthy elderly: a randomized clinical trial
Secondary ID [1] 259919 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To develop a functional exercise program associated with dance aimed at healthy seniors and verify its effectiveness in terms of the following outcomes: flexibility, agility, quality of life and (the reduction of) depression 265526 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265684 265684 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We conducted a random clinical trial study in which 23 individuals were recruited.
Patients were randomized in two groups: control (CG) and intervention (GI). Patients were assessed at pre and post intervention by the instruments: Berg Scale (BBS), Tinetti balance and mobility scale, Timed Up and Go, Flexibility Assessment, Geriatric Depression Scale (GDS -15) and Assessment of Quality of Life Questionnaire by WHOQOL - BREF.
After the assessment procedure and the forming of groups, began a program of physical therapy intervention associated with dance therapy, with 60 minutes of therapy, 2 times per week for a total of 16 therapies. The intervention consisted of exercises in a lying, sitting and standing positions (following a trend of activities more easy to difficult) and dance taught by a physiotherapist. The dance therapy was performed from a selection of songs that have been choreographed and rehearsed with the elderly by the physiotherapist responsible for the research.
Initially there were 23 individuals who were randomized into IG (n = 12) and CG (n = 11). Both groups were initially evaluated. In IG a patient was excluded for having severe comorbidities (n = 11). At the end of the intervention period, there was another assessment in the IG and CG. In IG, 3 patients were excluded because they were absent from 4 sessions, with the maximum being allowed in skippable sessions being 3, for this reason they were excluded (n = 8).
All individuals allocated to the CG came back for the assessment (n = 11).
After analyzing the results between IG and CG we found positive differences in the IG in main outcomes analyzed. For this reason and for ethical reasons, the CG has received the same treatment after the trial ended. All participants were recruited from the community, for convenience and spontaneously and were not necessarily on the waiting list.
After intervention, the CG finished with 5 seniors.
Statistical analysis was performed using SPSS 14.0 for Windows Evaluation Version.
Intervention code [1] 264342 0
Rehabilitation
Intervention code [2] 264484 0
Lifestyle
Intervention code [3] 264485 0
Treatment: Other
Comparator / control treatment
All individuals allocated to the CG was instructed not to vary from their normal daily activites in 8 weeks. After this period they came back for the reassessment (n = 11) and received the same proposed treatment for the IG.
Control group
Active

Outcomes
Primary outcome [1] 266641 0
BALANCE

Berg Scale (BBS): Used to assess balance in elderly individuals. It is composed for 14 items with a maximum score of 56, each item having a scale of 5 options ranging from 0 to 4 points, where zero means that the subject is unable to perform the desired task and four refers to the subject that performing well.

Tinetti balance and mobility scale: Classifies aspects of gait and balance. It consists of 16 items, in which 9 are to balance and 7 for gait. A lower score indicates a poorer physical ability. The maximum score is 12 points for the gait, 16 to balance and 28 for both.
Timepoint [1] 266641 0
1 - Initial Evaluation for every participants (IG and CG)
2 - Intervention for 8 weeks, twice a week lasting 60 minutes per therapy
3- Final Evaluation for every participants (IG and CG) the ninth week post-randomization
Primary outcome [2] 266642 0
FLEXIBILITY and AGILITY

Flexibility Assessment: Was used the Bank of Wells to measure the extent of the back muscles chain stretching and lower limbs12. 3 measurements were performed, and we used the higher value measured for analysis. The test was conducted at the Bank of Wells with open and closed window.

Timed Up and Go: Assesses the agility. The patient have to rise from a chair, walk a distance of three meters, turn around and return. 3 tests were performed and the value adopted for analysis was the best
Timepoint [2] 266642 0
1 - Initial Evaluation for every participants (IG and CG)
2 - Intervention for 8 weeks, twice a week lasting 60 minutes per therapy
3- Final Evaluation for every participants (IG and CG) the ninth week post-randomization
Primary outcome [3] 266669 0
DEPRESSION and QUALITY of LIFE

Geriatric Depression Scale (GDS -15): It is one of the most frequently used for the detection of depression in the elderly. It consists of 15 negative questions where major results indicate a higher level of depression.

Assessment of Quality of Life Questionnaire by WHOQOL - BREF: It is an instrument of 26 questions about quality of life, developed by WHO. It is divided into four domains: physical, psychological, social relationships and environment.
Timepoint [3] 266669 0
1 - Initial Evaluation for every participants (IG and CG)
2 - Intervention for 8 weeks, twice a week lasting 60 minutes per therapy
3- Final Evaluation for every participants (IG and CG) the ninth week post-randomization
Secondary outcome [1] 276137 0
nil
Timepoint [1] 276137 0
nil

Eligibility
Key inclusion criteria
- Elderly over 60 years
- Healthy elderly without history of falls
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
individuals with associated diseases, such as neurological disorders, severe heart disease, sensory disorders, cognitive deficits or understanding, as well as those who had more than three absences during the 16 sessions (2 sessions per week - total: 8 weeks) totaling the intervention protocol

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)
Patients were randomized covertly, using identical envelopes, opaque sealed that contained the words intervention and control, and the procedure was performed by an individual who had no knowledge of the study. The envelopes were opened in the presence of participants and was initiated the formation of groups and the evaluation process, conducted by the same evaluator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomized with simple randomisation using a randomisation table created by computer software (ie computerised sequence generation, using identical envelopes, opaque sealed that contained the words intervention and control, and the procedure was performed by an individual who had no knowledge of the study. The envelopes were opened in the presence of participants and was initiated the formation of groups and the evaluation process, conducted by the same evaluator
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
10/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3339 0
Brazil
State/province [1] 3339 0
Parana

Funding & Sponsors
Funding source category [1] 264804 0
Self funded/Unfunded
Name [1] 264804 0
Suhaila Mahmoud Smaili Santos
Country [1] 264804 0
Brazil
Funding source category [2] 264805 0
University
Name [2] 264805 0
Londrina State University
Country [2] 264805 0
Brazil
Primary sponsor type
University
Name
Londrina State University
Address
Departament of Physical Therapy, University Hospital of Londrina.
Robert Koch Avenue, 60
CEP: 86038-440 - Londrina - Parana
Country
Brazil
Secondary sponsor category [1] 263916 0
Individual
Name [1] 263916 0
Suhaila Mahmoud Smaili Santos
Address [1] 263916 0
Rua Luiz Natal Bonin, 580, casa 26
CEP: 86047-240
Londrina - Parana
Country [1] 263916 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266781 0
Ethics Comittee of the Londrina State University
Ethics committee address [1] 266781 0
Ethics committee country [1] 266781 0
Brazil
Date submitted for ethics approval [1] 266781 0
15/12/2009
Approval date [1] 266781 0
10/03/2010
Ethics approval number [1] 266781 0
1/09/0269

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

Contacts
Principal investigator
Name 32440 0
Address 32440 0
Country 32440 0
Phone 32440 0
Fax 32440 0
Email 32440 0
Contact person for public queries
Name 15687 0
Suhaila Mahmoud Smaili Santos
Address 15687 0
Luiz Natal Bonin st, 580, house 26
CEP: 86047-240
Londrina - Parana
Country 15687 0
Brazil
Phone 15687 0
55 (43) 3371-2288
Fax 15687 0
55 (43) 3371-2288
Email 15687 0
[email protected]
Contact person for scientific queries
Name 6615 0
Suhaila Mahmoud Smaili Santos
Address 6615 0
Luiz Natal Bonin st, 580, house 26
CEP: 86047-240
Londrina - Parana
Country 6615 0
Brazil
Phone 6615 0
55 (43) 3371-2288
Fax 6615 0
55 (43) 3371-2288
Email 6615 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

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