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Older People Gait: Physiomechanics and Functionality

Primary Purpose

Old Age; Debility

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Balance training
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Debility focused on measuring Locomotion, Aging, Training, Physical Fitness, Gait, Quality of life, Health

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • volunteers
  • aged over 60 years
  • both sexes
  • not performing regular physical activity with professional monitoring

Exclusion Criteria:

  • 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.

Sites / Locations

  • Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Balance training

Strength training

Cardiorespiratory endurance training

Control group

Arm Description

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.

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

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

control group: who will receive educational lectures on health, walking and aging.

Outcomes

Primary Outcome Measures

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).
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.
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.
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

Secondary Outcome Measures

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.
Self-selected walking speed
Self-selected walking speed: This outcome will be measure in test of walking treadmill
Anthropometric data - Body mass
Body mass: measure in kilograms before and after interventions.
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.
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".
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).
Anthropometric data - Height
Height: measure in meters before and after interventions.
Anthropometric data - Body Mass Index
Body Mass Index: Weight and height will be combined to report the body mass index in kg/m2.
Spatial Parameter - Stride length
This outcome is measure by stride length in meters.
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).
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.
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.
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).
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.

Full Information

First Posted
March 25, 2020
Last Updated
April 1, 2021
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04348539
Brief Title
Older People Gait: Physiomechanics and Functionality
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility
Keywords
Locomotion, Aging, Training, Physical Fitness, Gait, Quality of life, Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balance training
Arm Type
Experimental
Arm Description
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.
Arm Title
Strength training
Arm Type
Experimental
Arm Description
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
Arm Title
Cardiorespiratory endurance training
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
control group: who will receive educational lectures on health, walking and aging.
Intervention Type
Other
Intervention Name(s)
Balance training
Other Intervention Name(s)
Strength training, Cardiorespiratory endurance training
Intervention Description
32 sessions will be held twice a week, with each session taking an average of 45 minutes
Primary Outcome Measure Information:
Title
Dynamic Balance
Description
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).
Time Frame
Change from baseline at 16 weeks
Title
Strength
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Cardiorespiratory endurance
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Static balance
Description
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
Time Frame
Change from baseline at 16 weeks
Secondary Outcome Measure Information:
Title
Locomotor Rehabilitation Index
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Self-selected walking speed
Description
Self-selected walking speed: This outcome will be measure in test of walking treadmill
Time Frame
Change from baseline at 16 weeks
Title
Anthropometric data - Body mass
Description
Body mass: measure in kilograms before and after interventions.
Time Frame
Change from baseline at 16 weeks
Title
Depressive symptoms
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey
Description
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".
Time Frame
Change from baseline at 16 weeks
Title
Fear of falling
Description
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).
Time Frame
Change from baseline at 16 weeks
Title
Anthropometric data - Height
Description
Height: measure in meters before and after interventions.
Time Frame
Change from baseline at 16 weeks
Title
Anthropometric data - Body Mass Index
Description
Body Mass Index: Weight and height will be combined to report the body mass index in kg/m2.
Time Frame
Change from baseline at 16 weeks
Title
Spatial Parameter - Stride length
Description
This outcome is measure by stride length in meters.
Time Frame
Change from baseline at 16 weeks
Title
Temporal Parameter - Swing time, contact time, time of balance
Description
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).
Time Frame
Change from baseline at 16 weeks
Title
Parameters of Pendular Mechanism - Internal Work
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Parameters of Pendular Mechanism - external work
Description
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.
Time Frame
Change from baseline at 16 weeks
Title
Parameters of Pendular Mechanism: total mechanical work
Description
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).
Time Frame
Change from baseline at 16 weeks
Title
Parameters of Pendular Mechanism: Recovery
Description
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.
Time Frame
Change from baseline at 16 weeks
Other Pre-specified Outcome Measures:
Title
Sociodemographic characteristics
Description
Anamnesis with basic information about age, sex, marital status, education, occupation, housing, occurrence of diseases, use of medication.
Time Frame
Change from baseline at 16 weeks
Title
Cognitive function
Description
Montreal Cognitive Assessment (MoCA), Portuguese version, evaluates 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructive abilities, conceptual thinking, calculations and guidance. The total score is 30 points; a value = 26 is considered normal.
Time Frame
Change from baseline at 16 weeks
Title
Lower limb flexibility
Description
Lower limb flexibility: sit and reach test. The individual sits in the chair with his leg extended, slowly leans forward, trying to touch his toes. A measurement is made from the toes to the fingertips.
Time Frame
Change from baseline at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: volunteers aged over 60 years both sexes not performing regular physical activity with professional monitoring Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Alexandre Peyré-Tartaruga, PhD
Phone
+555133085818
Email
leonardo.tartaruga@ufrgs.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Alexandre Peyré-Tartaruga, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90690200
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017
Results Reference
background

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Older People Gait: Physiomechanics and Functionality

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