- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859243
Effects of Two Types of Concurrent Training in Functional Performance and Cognitive Function of Older Adults
Effects of Traditional Concurrent Training and Concurrent Training Composed by Strenght Traning and Dance Classes in Functional Performance, Cognitive Function and Quality of Life of Older Adults: a Randomized Controlled Clinical Trial
The goal of this randomized controlled clinical trial is to identify and compare the impacts of traditional concurrent training and concurrent training consisting of strength training combined with dance classes on functional performance, cognitive function and quality of life in older people. The main question it aims to answer are:
• The concurrent training consisting of strength training combined with dance classes can provide similar benefits to traditional concurrent training in neuromuscular and cardiorrespiratory performance, cognitive function and quality of life in older people?
Participants will training one of the two types of concurrent training (traditional concurrent training or concurrent training consisting of strength training combined with dance classes), two times a week, over 12 weeks.
Researchers will compare traditional concurrent training, concurrent training consisting of strength training combined with dance classes and a control group without exercise to see if this modalitys of physical exercise can provide increases in neuromuscular and cardiorrespiratory performance, cognitive function and quality of life in older people.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
- Escola de Educação Física, Fisioterapia e Dança - UFRGS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Be male or female aged between 65 and 75 years old
- Do not practice regular physical exercises for at least three months
- No history of competitive sports throughout life
- Not having musculoskeletal and neurological diseases or disorders that may influence the performance of the exercises or affect the test results
- Not having health conditions in which physical exercise is contraindicated
- Achieve a score of no less than 24 on the Mini Mental State Exam
- Achieve a score of up to 9.11 on the Baecke Physical Activity Questionnaire.
Exclusion criteria:
- Miss more than 20% of training sessions
- Miss more than three workouts in a row
- Failure to attend any of the evaluations will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Traditional concurrent training
The subjects will perform two concurrent training sessions, of approximately one hour per week.
Composed of strength exercises and aerobic exercise (walking outdoors and/or treadmill).
|
The subjects will perform two sessions per week of traditional concurrent training, consisting of strength training followed by aerobic exercise over 12 weeks, with progressive intensities and training volumes.
Each traditional concurrent training session will consist of specific warm-up performed on equipment for upper and lower limbs with a load of less than 30% of the training load.
Then the bench press, low row, leg press, extension and knee flexion exercises will be performed.
Participants will be instructed to perform the concentric phase of the movement in one second and the eccentric phase in two seconds.
After strength training, aerobic training (walking outdoors or on a treadmill) will be performed with intensity based on the adapted BORG effort perception scale (ranged to 0 = minimum effort, to 10 = maximal effort).
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|
Experimental: Concurrent training consisting of strength training combined with dance classes
The subjects will perform two concurrent training sessions associated with dance classes, of approximately one hour per week.
Composed of strength exercises and dance classes.
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Each concurrent training session associated with dance classes will consist of the same strength training as the traditional concurrent training group, but the traditional aerobic training will be replaced by a dance class.
Each dance class will consist of a 5-minute general warm-up with joint mobility exercises and dynamic stretching.
Then the main part will be performed with the elaboration of choreography, lasting approximately 20 minutes.
Finally, there will be a 5-minute cool-down with stretching exercises.
Classes will be held in four different dance modalities, divided into four modules.
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No Intervention: Control
Subjects will be instructed to maintain their usual routine during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dynamic balance
Time Frame: Baseline, 8 and 12 weeks
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Assessed by Timed Up and Go Test
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Baseline, 8 and 12 weeks
|
|
Change in Cognitive function
Time Frame: Baseline, 8 and 12 weeks
|
Assessed by Mini Exam of Mental State
|
Baseline, 8 and 12 weeks
|
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Change in Self reported quality of life
Time Frame: Baseline, 8 and 12 weeks
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Assessed by World Health Organization Quality of Life Questionary, on a scale ranging from 26 to 130. Higher scores are considered better.
|
Baseline, 8 and 12 weeks
|
|
Change in Static Balance
Time Frame: Baseline, 8 and 12 weeks
|
Assessed by One leg Stance Test
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Baseline, 8 and 12 weeks
|
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Change in Seat to Stand Capacity
Time Frame: Baseline, 8 and 12 weeks
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Assessed by 30s Seat to Stand Test
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Baseline, 8 and 12 weeks
|
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Change in Stairs Climb Capacity
Time Frame: Baseline, 8 and 12 weeks
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Assessed by 10 step climb test
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Baseline, 8 and 12 weeks
|
|
Change in Leg Strenght
Time Frame: Baseline, 8 and 12 weeks
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Assessed by One repetition maximum knee extension test
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Baseline, 8 and 12 weeks
|
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Change in Leg Power
Time Frame: Baseline, 8 and 12 weeks
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Assessd by 30% and 70% of One repetition maximum knee extension Test
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Baseline, 8 and 12 weeks
|
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Change in Hand Grip Strenght
Time Frame: Baseline, 8 and 12 weeks
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Assessed by Hand Grip Test with Hydraulic Dynamometer
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Baseline, 8 and 12 weeks
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Change in Cardiorrespiratory Capacity
Time Frame: Baseline, 8 and 12 weeks
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Assessed by the 6 minutes walk test
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Baseline, 8 and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quadriceps muscle thickness
Time Frame: Baseline and 12 weeks
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Assessed by ultrasound
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Baseline and 12 weeks
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Change in Affectivity with the intervention
Time Frame: 8 and 12 weeks
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Assessed by Scale (+5 = very good, -5 = very bad)
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8 and 12 weeks
|
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Change in Lipid profile
Time Frame: Baseline and 12 weeks
|
plasma concentrations of total cholesterol, HDL and triglycerides will be determined by the colorimetric method with specific kits in an automatic analyzer (Cobas C111, Roche Diagnostics, Basel, Switzerland).
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Baseline and 12 weeks
|
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Change in Specific tension of quadriceps
Time Frame: Baseline and 12 weeks
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Calculated by the formula: maximum knee extension strength/quadriceps muscle thickness
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Baseline and 12 weeks
|
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Change in depressive symptoms
Time Frame: Baseline and 12 weeks
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Measured using the Geriatric Depression Scale, that consists of 15 questions with binary answers (yes/no) and easy to understand.
It ranges from zero (absence of depressive symptoms) to fifteen points (maximum score of depressive symptoms).
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Baseline and 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- uRioGrandeLAPEx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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