Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000597099
Ethics application status
Approved
Date submitted
18/06/2010
Date registered
23/07/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of flexibility and strength training on functional performance in active elderly people
Scientific title
Effects of 12 weeks of stretching and/or strength training, followed by 6 weeks of detraining, on the functional status in the healthy elderly
Secondary ID [1] 252059 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiorespiratory health 257582 0
musculoskeletal health. 257583 0
Condition category
Condition code
Cardiovascular 257758 257758 0 0
Hypertension
Musculoskeletal 257759 257759 0 0
Normal musculoskeletal and cartilage development and function
Cardiovascular 257760 257760 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Forty five healthy elderly individuals (25 female gender; 20 male gender; 67.5±2 years old) completed the following study protocols: Control Group-CG (66±6 years old; n=13) just received advice about a healthy life style via lectures twice a week for 1h each, and carried out no physical or therapeutic exercise during 18 consecutive weeks; resistance group- RG (69±5 years old; n=13 performed resistive exercises; Stretching group- SG (69±6 years old; n=10) carried out stretching exercises; Resistance and stretching group-RSG (66±5 years old; n=09) carried out resistive exercises and immediately after by the stretching.
The exercises were oriented by the work team of the present study and applied under the supervision of a physiotherapist and 3 students from the course in physical therapy at the coastal sector of Universidade Federal do Parana. Blood pressure was checked before and 6 minutes after each session of exercises. The exercises were carried out twice a week, always at the same time, for a total of 24 sessions, each session lasting approximately 55 min, i.e., resistive exercise and stretching. Stretching or resistive exercise sessions were shorter. Individuals who took part in at least 60% of the sessions were considered as active participants of the study.
Resistive Exercise Protocol
The ten repetition maximum (10-RM) technique was used to evaluate the muscular strength of each individual in order to choose the ideal weight to use in the exercise. The 10-RM technique evaluates the capacity of the individual with respect to the maximum weight he can move 10 times with little action of muscle groups that are not the primary motors of the movement under evaluation.
The individuals were submitted to progressive resistive exercises, that is, for the first 5 weeks they used 65% of 10-RM, for the next 4 weeks, 70% and for the last 3 weeks, 75%. Adjustment of the 10-RM was determined immediately before the third and eighth weeks of training.
The protocol of resistive exercises consisted of 3 series of 8 repetitions of each exercise, carried out with both limbs.
The resistive exercises were carried out twice a week for 12 consecutive weeks for the following muscle groups: knee extensors (seated position) and knee flexors (standing upright); hip extensors (standing upright) and flexors (lying down on back); and the hip abductors and adductors (standing upright). The plantiflexors were tested in the upright standing position using the bodies own weight modified.
Stretching Procedure
Stretching exercises consisted of a series of 4 repetitions of active static stretching, each lasting 1 minute, with 1 min of relaxation between each repetition, respecting the tension limit of each individual. The exercises were carried out with both limbs twice a week for 12 consecutive weeks. The type of stretching, duration and number of repetitions.
Stretching of the following muscle groups of the lower limbs was carried out: knee extensors and dorsiflexors in the upright standing position; knee flexors and plantiflexors were stretched using a band of non-elastic material, with the subject lying on his back and the stretched limb with the knee extended and the ankle joint in dorsiflexion, using. In this case the contralateral limb was placed with the hip and knees flexed during the knee flexor stretching procedure.
Intervention code [1] 256681 0
Lifestyle
Intervention code [2] 256687 0
Other interventions
Comparator / control treatment
Forty five healthy elderly individuals (25 female gender; 20 male gender; 67.5±2 years old) completed the following study protocols: CG (66±6 years old; n=13) just received advice about a healthy life style via lectures, and carried out no physical or therapeutic exercise during 18 consecutive weeks; RG (69±5 years old; n=13 performed resistive exercises; SG (69±6 years old; n=10) carried out stretching exercises; RSG (66±5 years old; n=09) carried out resistive exercises and immediately after by the stretching.
Control group
Active

Outcomes
Primary outcome [1] 258637 0
Cardio-respiratory performance was evaluated using the 6 minute walk test (6MWT),
Timepoint [1] 258637 0
It was measured beforehand, after 6 and 12 weeks of training and after 6 weeks of detraining.
Primary outcome [2] 258641 0
Lower body muscle strength by standing up from a chair and sitting down (SUCSD).
Timepoint [2] 258641 0
It was measured beforehand, after 6 and 12 weeks of training and after 6 weeks of detraining.
Primary outcome [3] 258642 0
Blood pressure assessed by automatic sphygmomanometer
Timepoint [3] 258642 0
It was measured beforehand, after 6 and 12 weeks of training and after 6 weeks of detraining.
Secondary outcome [1] 264951 0
none
Timepoint [1] 264951 0
none

Eligibility
Key inclusion criteria
Eligibility Criteria
Men and women over 60 years of age and in a stable health condition; users of the Brazilian National Health System (SUS); presenting a medical certificate affirming they were able to carry out the proposed exercises; and individual who had not carried out regular physical activity over the last 6 weeks, were included.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The participants were excluded if they had secondary joint injury or surgery; cardiac illness; cancer; neuropathies; were users of prosthesis; had a systolic blood pressure above 200 mmHg and diastolic blood pressure above 110 mmHg at rest; had already taken part in structured exercise for more than 1 day a week during the previous 6 weeks; had any contraindications for exercise; severe functional limitations or cognitive impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants were recruited at meetings organized by the Municipal Health secretary of Matinhos-PR, via advertisements on the local radio, and information talks at local community and senior citizen groups. It was asked if the person would like to do exercise or only to be evaluated (control group) and they could choose which group theu would like to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2701 0
Brazil
State/province [1] 2701 0
Parana

Funding & Sponsors
Funding source category [1] 257150 0
University
Name [1] 257150 0
Universidade Federal do Parana
Country [1] 257150 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] 256410 0
University
Name [1] 256410 0
Federal University of Parana
Address [1] 256410 0
Physiotherapy Clinic School
R. Arthur Zanluti, 1402
MAtinhos-PR
BRazil
83260-000
Country [1] 256410 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259194 0
Human Research Ethics Committee of the Federal University of Parana Health Sciences
Ethics committee address [1] 259194 0
Ethics committee country [1] 259194 0
Brazil
Date submitted for ethics approval [1] 259194 0
04/04/2008
Approval date [1] 259194 0
06/05/2008
Ethics approval number [1] 259194 0
CAAE 0021.0.091.000-08

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

Contacts
Principal investigator
Name 31301 0
Address 31301 0
Country 31301 0
Phone 31301 0
Fax 31301 0
Email 31301 0
Contact person for public queries
Name 14548 0
Anna Raquel Silveira Gomes
Address 14548 0
R. Jaguariaiva, 512
Matinhos-PR
Brasil
83260-000
Country 14548 0
Brazil
Phone 14548 0
55-41-35118300
Fax 14548 0
Email 14548 0
[email protected]
Contact person for scientific queries
Name 5476 0
Rafaella Locks
Address 5476 0
Rua Eduardo Carlos Pereira, 4021, apto.802 – Portao, 81020-770
Curitiba – PR Brazil
Country 5476 0
Brazil
Phone 5476 0
55-41-96154487
Fax 5476 0
Email 5476 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
Dimensions AIEffects of strength and flexibility training on functional performance of healthy older people2012https://doi.org/10.1590/s1413-35552012000300003
N.B. These documents automatically identified may not have been verified by the study sponsor.