Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001105033
Ethics application status
Approved
Date submitted
23/05/2010
Date registered
17/12/2010
Date last updated
17/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of stretching on muscle performance and functionality of institutionalized elderly women
Scientific title
Effects of stretching on muscle performance and functionality of institutionalized elderly women
Secondary ID [1] 253267 0
none
Universal Trial Number (UTN)
U1111-1115-1115
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of stretching on muscle performance and functionality of institutionalized elderly women 257440 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257589 257589 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Initially, 142 women were contacted via the administration of a long term care facility. Sixty-one women were excluded from the study as they presented limited mobility condition (use of wheel chair, cane or other walking devices), 10 were found to experience health problems and 52 subjects presented restrictions to the practice of physical activities. Thus, nineteen elderly women were divided into 2 groups at random: Control Group (CG, n=09) participated in enjoyable-cultural activities as playing with balloons or balls, the chair dance and movements of the upper and lower limbs; The Stretching Group (SG, n=07) performed active stretching of hamstrings, 4 bouts of 1 min each. Both groups were supervised 3 times per week over a period of 8 weeks.
Intervention code [1] 256537 0
Other interventions
Comparator / control treatment
After recruited, subjects were randomly assigned in the control group (CG; n=9), which received educative talks about health habits and cultural activities or in the second group- The Stretching Group (SG, n=07) performed active stretching of hamstrings, 4 bouts of 1 min each. Both groups were supervised 3 times per week over a period of 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 258506 0
Peak torque was assessed by an isokinetic. Both groups were evaluated by The Photogrammetric Method to assess muscle-tendon length of uni- and biarticular hip flexors and hamstring flexibility.
Timepoint [1] 258506 0
Both groups (control-GC and Stretching-SG) were evaluated before and 8 weeks later.
Secondary outcome [1] 264307 0
Nil
Timepoint [1] 264307 0
Nil

Eligibility
Key inclusion criteria
Eligible criteria were present non-limited physical and cognitive conditions evaluated by the following: Mini Mental State Exam-MMSE, Barthel Index and Lysholm Scoring Scale. The MMSE questionnaire was conducted to determine the cognitive ability of the subjects according to education level and it had to be more than 13, while the Barthel Index to establish the activities of daily living (ADL) had also to be more than 13 and the Lysholm Scoring Scale was applied to assess knee functional status which had to set up at 84.
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
The procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) was done using a central randomisation by computer. Nineteen institutionalized female elderly nursing home residents were randomized to the Stretching Group (SG, n=10) or to the Control Group (CG, n=09). The total number of participants that completed the study is shown (n=17). To be included the participants were submitted to The MMSE questionnaire to determine their cognitive ability according to education level and it had to be more than 13, also the Barthel Index to establish the activities of daily living (ADL) which should reach more than 13 and the Lysholm Scoring Scale was applied to assess knee functional status which had to set up at 84.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For randomization was used random number table
2. Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment outside Australia
Country [1] 2651 0
Brazil
State/province [1] 2651 0
Parana

Funding & Sponsors
Funding source category [1] 257027 0
University
Name [1] 257027 0
Department of Physical Education, Federal University of Parana, Curitiba, Parana, Brazil
Country [1] 257027 0
Brazil
Primary sponsor type
Other
Name
Sao Vicente de Paulo long-stay Institution, Curitiba, Parana, Brazil.
Address
Barao dos Campos Gerais, 970
Curitiba - PR
CEP: 80.030-400
Country
Brazil
Secondary sponsor category [1] 256283 0
Other
Name [1] 256283 0
Knee Clinic, Curitiba, Parana, Brazil.
Address [1] 256283 0
Getulio Vargas, 3066
Agua Verde - Curitiba - PR
CEP 80610-010
Country [1] 256283 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259042 0
Ethics Committee of the Parana Federal University
Ethics committee address [1] 259042 0
Ethics committee country [1] 259042 0
Brazil
Date submitted for ethics approval [1] 259042 0
01/02/2009
Approval date [1] 259042 0
01/04/2009
Ethics approval number [1] 259042 0
CAAE-0003.0.91.000-09

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

Contacts
Principal investigator
Name 31210 0
Address 31210 0
Country 31210 0
Phone 31210 0
Fax 31210 0
Email 31210 0
Contact person for public queries
Name 14457 0
Daniela Gallon
Address 14457 0
Av Presidente Kennedy, 1823 apto 13, Bairro: Agua Verde, CEP: 80610-010, Parana, Curitiba (PR), Brazil.
Country 14457 0
Brazil
Phone 14457 0
+55 (41) 99469611
Fax 14457 0
+55 (41) 35118300
Email 14457 0
[email protected]
Contact person for scientific queries
Name 5385 0
Anna Raquel Silveira Gomes
Address 5385 0
R. Jaguariaiva, 512
Caioba
Matinhos-Parana
Brasil
CEP: 83260-000
Country 5385 0
Brazil
Phone 5385 0
+55 (41) 8406-1100
Fax 5385 0
+ 55 (41) 35118300
Email 5385 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
No additional documents have been identified.