Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000903088
Ethics application status
Approved
Date submitted
16/10/2010
Date registered
25/10/2010
Date last updated
27/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Static Stretching techniques and Hold- Relax on flexibility, mobility, balance and cadence healthy elderly.
Scientific title
To evaluate the effect of a stretching program for four weeks, with the techniques of Static Stretching and Hold- Relax on the range of motion, mobility, balance and cadence of healthy elderly.
Secondary ID [1] 252926 0
none
Universal Trial Number (UTN)
U1111-1117-4301
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retraction of the hamstrings 258427 0
Balance 258428 0
Mobility 258429 0
Cadence 258430 0
Condition category
Condition code
Musculoskeletal 258593 258593 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty-nine healthy sedentary elderly completed the study protocol: Control Group (GC) (64 + / - 5 years, n = 8) performed the tests and participated in lectures and cultural and recreational activities, (n 66 + / - 8 years, n = 10), Static Stretching Group (SSG) and Hold- Relax Group (HRG) (69 + / - 5 years, n = 11) were tested and stretching exercises and performed by a physical educator. The elderly woman was positioned lying supine with the spine aligned horizontally and one set of legs lying on the extension of the body, with 0o of hip flexion by a band of tissue, 2) to the Static Stretching (SS) the other leg held a flexion hip and knee extension, the ceiling for each participant until a restriction point but not in pain, then, the physical educator passively maintain the position from the point mentioned, during 60 seconds.
In the Proprioceptive Neuromuscular Facilitation (PNF) technique was used to hold-relax (HR). This technique is similar to the Contract-Relax technique (CR), except that the antagonistic muscle pattern resists enough to cause an isotonic contraction and not, as in Contract- Relax (CR). In HRG, the participant was supine and the therapist positioned the leg to be stretched in flexion, adduction and external rotation of the hip, extended knee, dorsiflexion with inversion of the foot to reach the restriction point. Once reached the restriction point, the senior was asked to perform an isometric contraction matching in the sense of extension, abduction and internal rotation of the thigh, knee extended, plantar flexion with eversion for 10 s.
Immediately after, we asked the research subjects, the relaxation of the limb, followed by 20 s of passive stretching in the direction of flexion, adduction and external rotation of thigh, knee extended, dorsiflexion with foot inversion. And from this new range of motion possible, repeat the procedure a total of 60 S. The interventions were performed for 60 seconds in both lower limbs, once a day, twice a week for four consecutive weeks.
Both HRG and SSG performed ten minutes of warm-up before stretching exercises.The following tests were performed before and after the program of stretching exercises: photogrammetry to assess range of motion of the hamstring muscles, Berg Balance Scale (BBS) to assess balance, Timed up and go for mobility and step counts per minute to assess the cadence.
Intervention code [1] 257424 0
Other interventions
Intervention code [2] 257448 0
Lifestyle
Comparator / control treatment
Twenty-nine elderly healthy sedentary completed the study protocol: GC (64 +/-5 years, n = 8) performed the tests and participated in lectures and recreational and cultural activity, SSG (66 +/-8 years, n = 10) underwent testing and static stretching exercises and HRG (69 +/- 5 years, n = 11) performed the tests and hold-relax stretching exercises, both SSG and HRG performed warm-up ten minutes prior to stretching exercises.
Control group
Active

Outcomes
Primary outcome [1] 259440 0
Flexibility was measured using photogrammetry, which assessed the range of motion of the hamstrings.
Timepoint [1] 259440 0
The variable flexibility was measured before and after four weeks of training with static stretching exercises and hold-relax.
Primary outcome [2] 259441 0
Mobility was assessed using the Timed up and go.
Timepoint [2] 259441 0
The mobility was assessed before and after four weeks of training with static stretching exercises and hold-relax.
Primary outcome [3] 259442 0
Balance was assessed by the Berg Balance Scale (BBS)
Timepoint [3] 259442 0
The balance was evaluated before and after four weeks of training with static stretching exercises and hold-relax.
Secondary outcome [1] 265992 0
Cadence was assessed by count the number of steps per minute.
Timepoint [1] 265992 0
Cadence was evaluated before and after four weeks of training with static stretching exercises and hold-relax.

Eligibility
Key inclusion criteria
Included were women aged 57 to 80 years and in stable health conditions, with the physical ability to perform the exercises and had not performed regular exercise in the last eight weeks.
Minimum age
57 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria were: secondary joint damage, heart disease, cancer, neurological disorders, prosthetic use, systolic blood pressure above 200mmHg and diastolic blood pressure above 110 mmHg, regular exercise participation over the last eight weeks, anti-indication for exercise, severe functional limitations or cognitive dysfunction.

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)
This study is experimental, with random assignment and control groups. The subjects were selected by random assignment. He was given a number to each individual sample. The numbers were placed in numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The subjects were selected by random assignment. He was given a number to each individual sample. The numbers were placed in numbered containers. Three groups were formed, the control group (CG), static stretching (SSG) and hold-relax stretching (HRG). From the table of random numbers, the first number found from 00 to 37 (effectively started the study 38 women), went to SSG, the second for the HRG and the third for the GC and so on, until you find all numbers from 00 to 37. Where n = 13 for the SSG, n = 13 for HRG and n = 12 for the GC. Even with these exclusions, 29 elderly completed the study. Groups were divided as follows: SSG, n = 10, HRG, n = 11 and CG, n = 8.
Masking / blinding
Open (masking not 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
26/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2978 0
Brazil
State/province [1] 2978 0

Funding & Sponsors
Funding source category [1] 257859 0
University
Name [1] 257859 0
Universidade Federal do Parana (UFPR)
Country [1] 257859 0
Brazil
Funding source category [2] 257860 0
University
Name [2] 257860 0
Universidade Paranaense UNIPAR
Country [2] 257860 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Parana- UFPR
Address
R, Jaguariaiva, 512 Matinhos, Parana Brasil 83260-000
Country
Brazil
Secondary sponsor category [1] 257064 0
University
Name [1] 257064 0
Universidade Paranaense UNIPAR
Address [1] 257064 0
Mascarenhas de Moraes, 4282 Zona III Umuarama -Parana Brasil 87502-210
Country [1] 257064 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259894 0
Human Research Ethics Committee of the University of Parana-UNIPAR
Ethics committee address [1] 259894 0
Universidade Paranaense UNIPAR

Mascarenhas de Moraes, 4282 Zona III
Umuarama -Parana Brasil 87502-210
Ethics committee country [1] 259894 0
Brazil
Date submitted for ethics approval [1] 259894 0
Approval date [1] 259894 0
16/04/2010
Ethics approval number [1] 259894 0
CAAE: 0008.0.375.000-10

Summary
Brief summary
To evaluate the effect of static stretching techniques (SS) and hold-relax (HR) on the range of motion (ROM), balance, mobility, and cadence of healthy elderly. Methods: We selected 29 women aged 68 +/- 11 years. The participants were divided randomly into three groups: control group (CG) (n = 8), group SS (SSG) (n = 10) and group HR (HRG) (n = 11). CG performed the tests and attended lectures. The SSG conducted a session of 60 seconds of SS passive and HRG, a 60-second session of stretching HR. Stretching exercises were performed in the hamstring muscles of both legs, after 10 min of warm-up, twice a week for four consecutive weeks. Evaluations were performed before and after intervention of ROM through photogrammetry, balance, through the Berg Balance Scale (BBS), the mobility using the Timed up and go and cadence by count the steps per minute. Results: An increase in ROM for SSG and increase in HRG and scores of BBS Timed up and go and cadence only to the HRG. Conclusion: The techniques of stretching SS and HR promoted increased ROM of the hamstrings and HR technique was more effective than SS in improving balance, mobility, and cadence of elderly.
Trial website
Trial related presentations / publications
Part of this study was presented at the XIII Conference Trans Learning (2010).
Public notes

Contacts
Principal investigator
Name 31791 0
Address 31791 0
Country 31791 0
Phone 31791 0
Fax 31791 0
Email 31791 0
Contact person for public queries
Name 15038 0
Claudinara Botton Dal Paz
Address 15038 0
Av Correa Lima, 666, Centro. Vicente Dutra - RS CEP 98450.000
Country 15038 0
Brazil
Phone 15038 0
(55) 3737 1155 (55) 9658 7769
Fax 15038 0
5537371073
Email 15038 0
narabotton@yahoo.com.br
Contact person for scientific queries
Name 5966 0
Anna Raquel Silveira Gomes
Address 5966 0
The George Institute for Global Health | AUSTRALIA
Level 7, 341 George St | Sydney NSW 2000 Australia
Country 5966 0
Australia
Phone 5966 0
T +61 2 9657 0397
Fax 5966 0
Email 5966 0
annaraquelsg@gmail.com

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