Old Age; DebilityNCT04348539
Older People Gait: Physiomechanics and Functionality
A study testing Balance training in people with Old Age; Debility, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility
- What is being tested?
- Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- May 2021to Mar 2022
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- volunteers
- aged over 60 years
- both sexes
- not performing regular physical activity with professional monitoring
Who cannot join
- not participate in all stages of the evaluation
- severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
- stroke or other associated neurological diseases; insanity;
- prostheses in the lower limbs;
- without ambulation conditions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690200
About this study
Official title: Evaluation of the Effects of Coordination, Strength and Cardiorespiratory Endurance Training on Physical Fitness, Kinematic and Physiomechanics Parameters of Gait and Indicators Associated With the Quality of Life in Older People
The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life.
Read the detailed description
Objective: Evaluate and compare the effects of different types of training (balance training, strength training, cardiorespiratory endurance training); in the older people in the variables of physical fitness (dynamic balance, static balance, rate of strength production, flexibility and cardiorespiratory endurance), physiomechanics of gait (length and frequency of stride, time of contact and balance, energy conversion, mechanical work , transport cost, dynamic stability and mechanical efficiency of walking at different speeds), indicators associated with quality of life (depressive symptoms, health-related quality of life, fear of falling). Experimental Design: study experimental randomized. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil. Participants: older people from the community of both sexes, aged 60 or over, sedentary. Interventions: In this research, three groups of older people will receive intervention during 4 months of different types of training (balance training, strength training, cardiorespiratory endurance training); and a control group, who will receive educational lectures on health, walking and aging. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is same between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by exercise time. The training programs will have a frequency of two sessions per week and a duration of 45 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period. Outcomes: the results will be related to the variables physical fitness, physiomechanics of gait, and indicators associated with quality of live. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05, and Bonferroni post-hoc to identify the differences between the means in all variables. Expected Results: The investigators believe that the better the level of physical fitness, the less likely it is that the elderly will enter into a frame of disability or fragility, especially improving physical fitness when compared to the control group. In addition, strategies to protect the elderly can be formulated through physical programs aimed at preventing the functional capacity and quality of life of the elderly. It is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental.
- Conditions
- Old Age; Debility
- Being tested
- Balance training
- Keywords
- Locomotion, Aging, Training, Physical Fitness, Gait, Quality of life, Health
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Also called Strength training, Cardiorespiratory endurance training
32 sessions will be held twice a week, with each session taking an average of 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | The balance training consists of 3 moments: warm up, main and stretch. Warm-up with mobility exercises for major joints and large muscle groups. The main part will have eight exercise stations divided into: a) five balance exercises (dynamic and static with or without object balance) on a varied floor, b) three agility exercises, and a stretching of the worked muscle groups and a final relaxation. Receives: Other: Balance training |
| Strength training | Experimental | Muscle strength training will consist of 3 moments: warm up, main and stretch. Warm up with mobility exercises for the main joints and large muscle groups. The main part will include strength exercises with lower and upper limbs with two sets of 6-12 repetitions according to periodization, and a stretching of the muscle groups worked Receives: Other: Balance training |
| Cardiorespiratory endurance training | Experimental | The older people walking training consists of 3 moments: warm up, main and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed, then walk according to the training cycle, and then a stretching of the main muscle groups. Will be held, twice a week for 45 minutes each session. The training intensity will follow 60-110% of the volume of the 6-minute Test (6MWT) and the Borg Scale at moderate to difficult intervals. the training Receives: Other: Balance training |
| Control group | No intervention | control group: who will receive educational lectures on health, walking and aging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance
Dynamic balance: Timed Get Up and Go test (distance of 3 meters), which give the time (seconds) that the individual takes to complete the path of the test as fast as possible (without running).
Measured: Change from baseline at 16 weeks
Strength
Lower limb strength: Test to get up and sit on the chair. The individual sits on the chair, with his arms crossed over his chest and at the signal starts the repetitions of getting up and sitting down for a total of 30 seconds. The number of repetitions the subject is able to perform is added.
Measured: Change from baseline at 16 weeks
Cardiorespiratory endurance
cardiorespiratory endurance: 6-minute test. The individual will walk in a 30 meters course for 6 minutes as fast as he can, without running, resulting in the distance covered in that interval.
Measured: Change from baseline at 16 weeks
Static balance
Static balance: force platform by means of the displacement rate of the centre of mass in the anteroposterior (Fx), medium-lateral (Fy) and vertical (Fz) axes. The older people must climb on the platform and unite their feet, keeping their gaze in a fixed linear point, the test will last for 30 seconds, it will be registered with the eyes open and closed
Measured: Change from baseline at 16 weeks
Secondary outcomes (14)
Locomotor Rehabilitation Index
Locomotor Rehabilitation Index: method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in percent, and when Locomotor Rehabilitation Index value is closer to 100 percent, it indicates that the participants are closer to their theoretical optimal walking speed.
Measured: Change from baseline at 16 weeks
Self-selected walking speed
Self-selected walking speed: This outcome will be measure in test of walking treadmill
Measured: Change from baseline at 16 weeks
Anthropometric data - Body mass
Body mass: measure in kilograms before and after interventions.
Measured: Change from baseline at 16 weeks
Depressive symptoms
Geriatric Depression Scale protocol: consists of 15 questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.
Measured: Change from baseline at 16 weeks
Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey
Medical Outcomes Study 36 - Item Short Form Health Survey: multidimensional questionnaire, formed by 36 items that encompass eight domains (functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health). The maximum score for each domain is 100, with the total sum being a maximum of 150, with zero being "worst" and 150 "best health status".
Measured: Change from baseline at 16 weeks
Fear of falling
Falls Efficacy Scale - International: questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can vary from 16 (no concern) to 64 (extreme concern).
Measured: Change from baseline at 16 weeks
Anthropometric data - Height
Height: measure in meters before and after interventions.
Measured: Change from baseline at 16 weeks
Anthropometric data - Body Mass Index
Body Mass Index: Weight and height will be combined to report the body mass index in kg/m2.
Measured: Change from baseline at 16 weeks
Spatial Parameter - Stride length
This outcome is measure by stride length in meters.
Measured: Change from baseline at 16 weeks
Temporal Parameter - Swing time, contact time, time of balance
Swing time in seconds, contact time in seconds, time of balance in seconds. The percentage of contact time will be calculated to measure the duty factor in percentual. The swing and contact time in seconds will be aggregated to distance in meters to arrive at frequency (in Hetz).
Measured: Change from baseline at 16 weeks
Parameters of Pendular Mechanism - Internal Work
The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
Measured: Change from baseline at 16 weeks
Parameters of Pendular Mechanism - external work
The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
Measured: Change from baseline at 16 weeks
Parameters of Pendular Mechanism: total mechanical work
The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The total mechanical work (Wtot =internal Work + External Work) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules).
Measured: Change from baseline at 16 weeks
Parameters of Pendular Mechanism: Recovery
The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.
Measured: Change from baseline at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Old Age; DebilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul
- Investigators
- Leonardo Alexandre Peyré-Tartaruga, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348539
- Sponsor's protocol ID
- GaitOlderpeople
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2020
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Coordination, Strength and Cardiorespiratory Endurance Training on Physical Fitness, Kinematic and Physiomechanics Parameters of Gait and Indicators Associated With the Quality of Life in Older People
- ClinicalTrials.gov ID
- NCT04348539
- Acronym / sponsor ID
- GaitOlderpeople
- Conditions
- Old Age; Debility
- Keywords
- Locomotion, Aging, Training, Physical Fitness, Gait, Quality of life, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 16 Apr 2020 (actual)
- 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.
The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life.
Detailed description
Objective: Evaluate and compare the effects of different types of training (balance training, strength training, cardiorespiratory endurance training); in the older people in the variables of physical fitness (dynamic balance, static balance, rate of strength production, flexibility and cardiorespiratory endurance), physiomechanics of gait (length and frequency of stride, time of contact and balance, energy conversion, mechanical work , transport cost, dynamic stability and mechanical efficiency of walking at different speeds), indicators associated with quality of life (depressive symptoms, health-related quality of life, fear of falling). Experimental Design: study experimental randomized. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil. Participants: older people from the community of both sexes, aged 60 or over, sedentary. Interventions: In this research, three groups of older people will receive intervention during 4 months of different types of training (balance training, strength training, cardiorespiratory endurance training); and a control group, who will receive educational lectures on health, walking and aging. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is same between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by exercise time. The training programs will have a frequency of two sessions per week and a duration of 45 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period. Outcomes: the results will be related to the variables physical fitness, physiomechanics of gait, and indicators associated with quality of live. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05, and Bonferroni post-hoc to identify the differences between the means in all variables. Expected Results: The investigators believe that the better the level of physical fitness, the less likely it is that the elderly will enter into a frame of disability or fragility, especially improving physical fitness when compared to the control group. In addition, strategies to protect the elderly can be formulated through physical programs aimed at preventing the functional capacity and quality of life of the elderly. It is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Balance trainingThe balance training consists of 3 moments: warm up, main and stretch. Warm-up with mobility exercises for major joints and large muscle groups. The main part will have eight exercise stations divided into: a) five balance exercises (dynamic and static with or without object balance) on a varied floor, b) three agility exercises, and a stretching of the worked muscle groups and a final relaxation. |
| Strength training | Experimental | Other: Balance trainingMuscle strength training will consist of 3 moments: warm up, main and stretch. Warm up with mobility exercises for the main joints and large muscle groups. The main part will include strength exercises with lower and upper limbs with two sets of 6-12 repetitions according to periodization, and a stretching of the muscle groups worked |
| Cardiorespiratory endurance training | Experimental | Other: Balance trainingThe older people walking training consists of 3 moments: warm up, main and stretch. They will do a brief free walking warm-up for 3 minutes in the Self-selected walking speed, then walk according to the training cycle, and then a stretching of the main muscle groups. Will be held, twice a week for 45 minutes each session. The training intensity will follow 60-110% of the volume of the 6-minute Test (6MWT) and the Borg Scale at moderate to difficult intervals. the training |
| Control group | No intervention | –control group: who will receive educational lectures on health, walking and aging. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteers
- aged over 60 years
- both sexes
- not performing regular physical activity with professional monitoring
Key exclusion criteria (5 listed)
- not participate in all stages of the evaluation
- severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
- stroke or other associated neurological diseases; insanity;
- prostheses in the lower limbs;
- without ambulation conditions.
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 |
|---|---|---|
| Balance trainingAlso: Strength training, Cardiorespiratory endurance training32 sessions will be held twice a week, with each session taking an average of 45 minutes | Other | Balance training, Cardiorespiratory endurance training, Strength training |
Primary outcome
Dynamic Balance
Time frame: Change from baseline at 16 weeks
Dynamic balance: Timed Get Up and Go test (distance of 3 meters), which give the time (seconds) that the individual takes to complete the path of the test as fast as possible (without running).
Strength
Time frame: Change from baseline at 16 weeks
Lower limb strength: Test to get up and sit on the chair. The individual sits on the chair, with his arms crossed over his chest and at the signal starts the repetitions of getting up and sitting down for a total of 30 seconds. The number of repetitions the subject is able to perform is added.
Cardiorespiratory endurance
Time frame: Change from baseline at 16 weeks
cardiorespiratory endurance: 6-minute test. The individual will walk in a 30 meters course for 6 minutes as fast as he can, without running, resulting in the distance covered in that interval.
Static balance
Time frame: Change from baseline at 16 weeks
Static balance: force platform by means of the displacement rate of the centre of mass in the anteroposterior (Fx), medium-lateral (Fy) and vertical (Fz) axes. The older people must climb on the platform and unite their feet, keeping their gaze in a fixed linear point, the test will last for 30 seconds, it will be registered with the eyes open and closed
14 secondary outcomes
Locomotor Rehabilitation Index
Time frame: Change from baseline at 16 weeks
Self-selected walking speed
Time frame: Change from baseline at 16 weeks
Anthropometric data - Body mass
Time frame: Change from baseline at 16 weeks
Depressive symptoms
Time frame: Change from baseline at 16 weeks
Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey
Time frame: Change from baseline at 16 weeks
Fear of falling
Time frame: Change from baseline at 16 weeks
Anthropometric data - Height
Time frame: Change from baseline at 16 weeks
Anthropometric data - Body Mass Index
Time frame: Change from baseline at 16 weeks
Spatial Parameter - Stride length
Time frame: Change from baseline at 16 weeks
Temporal Parameter - Swing time, contact time, time of balance
Time frame: Change from baseline at 16 weeks
Parameters of Pendular Mechanism - Internal Work
Time frame: Change from baseline at 16 weeks
Parameters of Pendular Mechanism - external work
Time frame: Change from baseline at 16 weeks
Parameters of Pendular Mechanism: total mechanical work
Time frame: Change from baseline at 16 weeks
Parameters of Pendular Mechanism: Recovery
Time frame: Change from baseline at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- BackgroundGONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017
- Individual participant dataSharing planned: No
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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.
Leonardo Alexandre Peyré-Tartaruga, PhD study director
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Old Age; Debility, run by Federal University of Rio Grande do Sul 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 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo Alexandre Peyré-Tartaruga, PhD (+555133085818, leonardo.tartaruga@ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance (time frame: Change from baseline at 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348539, which also lists 1 linked publication.
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 2 Apr 2021.