Health BehaviorNCT01526109
Effect of Strength Training and Whole Body Vibration in Healthy Elderly
A study testing Strength training group and Whole-body vibration training group in people with Health Behavior, run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
Quality of Life (Qol) is a complex concept which relates to the perception of subjective satisfaction, especially in elderly population. It also relates to the self-perception of psychological status, independence level, to the social relationships, and to the environment where the elderly person lives. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Strength training group and Whole-body vibration training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elderly (> 60 years)
- without diagnosis of mental illness or cognitive decline
- literate
- have not committed to physical exercises.
Who cannot join
- scored outside the cutoff point set in the scales of depressive symptoms (Beck > 18)
- cognitive decline (MSSE < 18 for low educational level and < 24 for high school).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strength Training and Whole Body Vibration on Cognitive Function, Behavioral and Functional Capacity in Healthy Elderly.
Quality of Life (Qol) is a complex concept which relates to the perception of subjective satisfaction, especially in elderly population. It also relates to the self-perception of psychological status, independence level, to the social relationships, and to the environment where the elderly person lives. Consequently, there are a number of factors which may change the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity, and the rupture of social relationship, as well as the aging process itself. Physical exercise is associated to improvement of mental and physical health. However, few studies investigated the effect of strength training and whole- body vibration training on elderly subjects. Following this line of reasoning, the purpose of the present study is to assess the effect of physical exercise on cognition and functional abilities in elderly subjects. Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a control group (CG). Main outcome measures: Cognitive function will be assessed using Mini Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness Test, American Alliance for Health, Physical Education, Recreation \& Dance(AAHPERD)functional fitness test, and Short Form 36(SF-36) health survey.
Read the detailed description
Design: Three-month controlled, randomized, and double-blind study. The subjects will be recruited from the Gama Filho University. They will be randomized with a blind design to a whole-body vibration training group (WBV), strength training group (STG) and control group (CG) by a researcher who will not participate of the initial assessments.
Intervention
The study is a longitudinal randomized clinical trial. The subjects will perform three visits to the laboratory where they will be submitted to neuropsychological, behavioral and physical evaluations. These evaluations will be performed before and after three months of training. Each visit will last about an hour and a half. After a period of one week of adaptation, subjects begin training with the charges set out in this study. All groups will carry out training twice a week, forty minutes, for three months. Next, will be described in detail the experimental procedures in each group:
STG Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts).
WBV Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration training twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk.
Control Group Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity.
- Conditions
- Health Behavior
- Being tested
- Strength training group, Control group, Whole-body vibration training group
- Keywords
- elderly, quality of life, functional capacity, cognitive function, physical exercise
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training groupBehavioural
Also called resistence training
Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts).
Control groupBehavioural
Also called no intensity
Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity
Whole-body vibration training groupBehavioural
Also called WBV training
Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk.
| Study group | Role | What they receive |
|---|---|---|
| strength training group | Experimental | Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts). Receives: Behavioral: Strength training group |
| Control group | Placebo comparator | Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity Receives: Behavioral: Control group |
| whole-body vibration training group | Experimental | Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk. Receives: Behavioral: Whole-body vibration training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks
The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality (energy and fatigue), perception of general health.
Measured: from date to randomization at 12 weeks
Secondary outcomes (7)
Change from baseline in Senior Fitness Test at 12 weeks
The assessment of functional capacity of patients will be conducted through the battery functional tests of the Senior Fitness Test. Will be evaluated regarding their balance, strength, lower limb and upper, flexibility, agility, running and cardiovascular fitness. The battery consists of seven physical tests: 1) Time to Up and Go (TUG), 2) get up and down, 3) flexibility and 4) strength of MI and MS, 5) 6-minute walk, 6) sit down and test achieve, and 7) test bench.
Measured: from date to randomization at 12 weeks
Change from baseline in American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test at 12 weeks
The participant begins the test in a chair with your heels flat on the floor. At the signal of "ready now" moves to the right and around a cone positioned at 1.50 m and 1.80 m behind to the side of the chair, returning to his chair and sat down. Immediately the participant gets up, moves to the left and around the second cone, returning to his chair and sat down again. So complete a circuit. The individual must complete two full circuits.
Measured: from date to randomization at 12 weeks
Change from baseline in Trail Making Test at 12 weeks
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper.
Measured: from date to randomization at 12 weeks
Change from baseline in Mini Metal State Examination (MMSE) at 12 weeks
The MMSE is a brief screening test for cognitive capabilities that evaluates orientation (spatial and time), attention, concentration, memory, calculation, language, and praxis. The score ranges from 0 to 30, with higher scores indicating better performance.
Measured: from date to randomization at 12 weeks
Change from baseline in Digit Test at 12 weeks
A series of number sequences are presented to the subject. In the first portion of the test, the subject is asked to reproduce the exact sequence, whereas in the second portion he/she is asked to repeat the sequence backwards. The Digit span evaluated attention, concentration and working memory.
Measured: from date to randomization at 12 weeks
change from baseline in Stroop Test at 12 weeks
There are three parts to the test. In Part 1, the subject must name the colors painted (blue, green, red and yellow) in a card. In Part 2, the subject reads the color names (blue, green, red and yellow) painted ignoring the printed words. In Part 3, the subject must name the color (blue, green, red and yellow) painted, ignoring the color name printed on the card, which is always different color painted.
Measured: from date to randomization at 12 weeks
Change from baseline in Rey Complex Figure Test at 16 weeks
It uses a complex geometric figure. The examinee is asked to copy the figure with as many details in a white paper in a horizontal position.
Measured: from date to randomization at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The study was finished since the University has been closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Andrea Camaz Deslandes, Universidade Gama Filho
- Investigators
- Andrea Deslandes, Dr, Principal investigator, UGF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526109
- Sponsor's protocol ID
- 040.2011
- Status last verified
- Feb 2012
- First submitted
- 31 Jan 2012
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Training and Whole Body Vibration on Cognitive Function, Behavioral and Functional Capacity in Healthy Elderly.
- ClinicalTrials.gov ID
- NCT01526109
- Acronym / sponsor ID
- 040.2011
- Conditions
- Health Behavior
- Keywords
- elderly, quality of life, functional capacity, cognitive function, physical exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was finished since the University has been closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jan 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quality of Life (Qol) is a complex concept which relates to the perception of subjective satisfaction, especially in elderly population. It also relates to the self-perception of psychological status, independence level, to the social relationships, and to the environment where the elderly person lives. Consequently, there are a number of factors which may change the perception of QoL, namely the occurrence of diseases, physical impairment or incapacity, and the rupture of social relationship, as well as the aging process itself. Physical exercise is associated to improvement of mental and physical health. However, few studies investigated the effect of strength training and whole- body vibration training on elderly subjects. Following this line of reasoning, the purpose of the present study is to assess the effect of physical exercise on cognition and functional abilities in elderly subjects. Design: Randomized controlled trial, double-blinded, with 12-week follow-up. Setting: Gama Filho University. Participants: Healthy Elderly. Interventions: The patients will be randomly assigned to a strength training group (STG), whole-body vibration training group (WBVG) and a control group (CG). Main outcome measures: Cognitive function will be assessed using Mini Metal State Examination (MMSE), Trail A and B, Digit Span, Stroop Test, Rey auditory-verbal learning test and Clock Test, and functional capacity will be evaluated using Senior Fitness Test, American Alliance for Health, Physical Education, Recreation \& Dance(AAHPERD)functional fitness test, and Short Form 36(SF-36) health survey.
Detailed description
Design: Three-month controlled, randomized, and double-blind study. The subjects will be recruited from the Gama Filho University. They will be randomized with a blind design to a whole-body vibration training group (WBV), strength training group (STG) and control group (CG) by a researcher who will not participate of the initial assessments.
Intervention
The study is a longitudinal randomized clinical trial. The subjects will perform three visits to the laboratory where they will be submitted to neuropsychological, behavioral and physical evaluations. These evaluations will be performed before and after three months of training. Each visit will last about an hour and a half. After a period of one week of adaptation, subjects begin training with the charges set out in this study. All groups will carry out training twice a week, forty minutes, for three months. Next, will be described in detail the experimental procedures in each group:
STG Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts).
WBV Group Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration training twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk.
Control Group Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| strength training group | Experimental | Behavioral: Strength training groupParticipants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts). |
| Control group | Placebo comparator | Behavioral: Control groupParticipants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity |
| whole-body vibration training group | Experimental | Behavioral: Whole-body vibration training groupParticipants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elderly (> 60 years)
- without diagnosis of mental illness or cognitive decline
- literate
- have not committed to physical exercises.
Key exclusion criteria (2 listed)
- scored outside the cutoff point set in the scales of depressive symptoms (Beck > 18)
- cognitive decline (MSSE < 18 for low educational level and < 24 for high school).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training groupAlso: resistence trainingParticipants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts). | Behavioural | strength training group |
| Control groupAlso: no intensityParticipants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity | Behavioural | Control group |
| Whole-body vibration training groupAlso: WBV trainingParticipants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk. | Behavioural | whole-body vibration training group |
Primary outcome
Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks
Time frame: from date to randomization at 12 weeks
The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality (energy and fatigue), perception of general health.
7 secondary outcomes
Change from baseline in Senior Fitness Test at 12 weeks
Time frame: from date to randomization at 12 weeks
Change from baseline in American Alliance for Health, Physical Education, Recreation & Dance(AAHPERD)functional fitness test at 12 weeks
Time frame: from date to randomization at 12 weeks
Change from baseline in Trail Making Test at 12 weeks
Time frame: from date to randomization at 12 weeks
Change from baseline in Mini Metal State Examination (MMSE) at 12 weeks
Time frame: from date to randomization at 12 weeks
Change from baseline in Digit Test at 12 weeks
Time frame: from date to randomization at 12 weeks
change from baseline in Stroop Test at 12 weeks
Time frame: from date to randomization at 12 weeks
Change from baseline in Rey Complex Figure Test at 16 weeks
Time frame: from date to randomization at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Deslandes, Dr principal investigator
UGF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training group and Whole-body vibration training group in people with Health Behavior, run by Universidade Gama Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Short Form 36 (SF-36) questionaire at 12 weeks (time frame: from date to randomization at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.