Clinical trial NCT04348539: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age; Debility
Keywords: Locomotion
Aging
Training
Physical Fitness
Gait
Quality of life
Health
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dynamic Balance
timeFrame: Change from baseline at 16 weeks
measure: Strength
timeFrame: Change from baseline at 16 weeks
measure: Cardiorespiratory endurance
timeFrame: Change from baseline at 16 weeks
measure: Static balance
timeFrame: Change from baseline at 16 weeks
Secondary outcomes:
measure: Locomotor Rehabilitation Index
timeFrame: Change from baseline at 16 weeks
measure: Self-selected walking speed
timeFrame: Change from baseline at 16 weeks
measure: Anthropometric data - Body mass
timeFrame: Change from baseline at 16 weeks
measure: Depressive symptoms
timeFrame: Change from baseline at 16 weeks
measure: Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey
timeFrame: Change from baseline at 16 weeks
measure: Fear of falling
timeFrame: Change from baseline at 16 weeks
measure: Anthropometric data - Height
timeFrame: Change from baseline at 16 weeks
measure: Anthropometric data - Body Mass Index
timeFrame: Change from baseline at 16 weeks
measure: Spatial Parameter - Stride length
timeFrame: Change from baseline at 16 weeks
measure: Temporal Parameter - Swing time, contact time, time of balance
timeFrame: Change from baseline at 16 weeks
measure: Parameters of Pendular Mechanism - Internal Work
timeFrame: Change from baseline at 16 weeks
measure: Parameters of Pendular Mechanism - external work
timeFrame: Change from baseline at 16 weeks
measure: Parameters of Pendular Mechanism: total mechanical work
timeFrame: Change from baseline at 16 weeks
measure: Parameters of Pendular Mechanism: Recovery
timeFrame: Change from baseline at 16 weeks
Other outcomes:
measure: Sociodemographic characteristics
timeFrame: Change from baseline at 16 weeks
measure: Cognitive function
timeFrame: Change from baseline at 16 weeks
measure: Lower limb flexibility
timeFrame: Change from baseline at 16 weeks
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Leonardo Alexandre Peyré-Tartaruga, PhD
role: STUDY_DIRECTOR
References:
citation: GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017