Clinical trial NCT06638697: CREM - Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults
Official title: CREM - Reference Center for Aging and Movement: Clinical and Functional Outcomes in a Controlled Clinical Trial with Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aged
Aged Subject
Keywords: elderly
functionality
physical exercise
cognition
physical fragility
physical fitness
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate and compare the effects of different types of physical exercise on clinical and functional outcomes in the elderly. 240 community-dwelling elderly individuals of both sexes, sedentary, will be recruited for twelve groups of elderly individuals who will receive intervention for 32 weeks of different types of physical exercise (free walking, Nordic walking, dancing, physical exercise for cognition, balance, aquatic physiotherapy, multicomponent gymnastics, water aerobics, hydro-postural exercises, aquatic jogging, weight training, and Pilates mat). The training programs will have a frequency of two sessions per week and will last 50 minutes and will be periodized so that the duration of the sessions is equal among them. In order to evaluate the effects of the training, evaluations will be carried out before, during and after the training period of functional fitness, clinical-functional and biomechanical parameters. It is expected that the intervention groups will present results according to the nature of the modality and that they will be more effective when compared to the control group. As well as improvements in the variables of gait speed, muscle strength, balance and cognition.


Eligibility criteria: Inclusion Criteria:

* elderly people over 60 years old,
* sex female our male,
* presenting medical authorization to practice exercises,
* being able to understand verbal instructions for carrying out the tests,
* having accessibility to carry out the training,
* coming from local Health Units and the community,
* presenting independent walking and not having participated in any physical activity for at least three months before starting the research.

Exclusion Criteria:

* not having a medical certificate indicating that they are fit to perform physical activity,
* presenting medical comorbidities and/or a medical condition that contraindicates participation in the study, severe heart disease, uncontrolled arterial hypertension, myocardial infarction within a period of less than one year or history of physical-cognitive impairment, sequelae of a stroke,
* having a pacemaker,
* having undergone recent surgery,
* prosthetics in the lower limbs or neuropathic pain in the lower limbs.

Primary outcomes:
measure: Lower Limb Strength
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Upper limb strength
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Upper limb flexibility
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Lower limb flexibility
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Aerobic endurance
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Static balance
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Dynamic balance
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Walking speed
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Secondary outcomes:
measure: Concern about falls
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Pain index
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Depressive symptoms
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
measure: Cognition
timeFrame: Assessments will take place before, during and after the training period at three times: 1) Pre-intervention (0 weeks), 2) after 16 weeks of training, 3) Post-intervention (32 weeks).
Other outcomes:
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