Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Changes in baseline depressive symptoms at two months. |
Test: The depressive state will be evaluated with a short version of the validated geriatric depression scale (GDS) in Brazil. There are 15 questions that inquire about feelings and a frequency that the person presents before certain conditions of life. These questions require categorical answers (yes or no). Of the 15 items, 10 indicate the presence of depression when answered positively. While the rest (1, 5, 7, 11 and 13) when answered negatively. A higher score indicates depression. |
Baseline and 8-weeks |
|
Primary |
Change in baseline test Time up and go at two months. |
Test: The time up and go will assess sitting balance, balance in transfers from sitting to standing, stability in ambulation and changes of direction. The test consists of the individual getting up from the chair, without arm support, walking 3 meters with safe and comfortable steps, without running, turning 180°, returning and sitting in the chair. The time taken to perform this task will be timed. Volunteers who perform the task in a time of less than 10 seconds will be considered with satisfactory mobility, for those who perform the test between 11 and 20 seconds will be classified with good mobility and for those who reach values greater than 20 seconds will be classified with mobility problems. |
Baseline and 8-weeks |
|
Primary |
Change in baseline balance test, mark speed, and sit and stand chair at two months |
The Short Physical Performance Battery (SPPB) in its Brazilian version will be performed, which includes the tests for standing static balance, gait speed, and lower limb muscle strength. The total score of the SPPB will be obtained by adding the score of each test, ranging from zero (worst capacity) to 12 (best capacity). The result can be graded as follows: 0 to 3 points: disability or poor capacity; 4 to 6 points: low capacity; 7 to 9 points: moderate capacity; and 10 to 12 points: good capacity. |
Baseline and 8-weeks |
|
Primary |
Change in Inhibitory control at two months |
Test: Victoria Stroop test. Inhibitory control will be evaluated using the Victoria Stroop Test, which uses three tasks with 24 items each. The participant is evaluated according to how quickly she performs the task and the number of errors. The effect of interference is determined by calculating the extra time required to name the colors (of the printout) compared to the time required to name colors in the first control task (colors of the cards). The task performed faster indicates better performance. |
Baseline and 8-weeks |
|
Primary |
Change in Working memory at two months |
Working memory will be evaluated by Digit Span Forward and Backward. For the calculation of the test, the sum of the longest sequence of digits repeated, without error, over two trials in direct order is used. |
Baseline and 8-weeks |
|
Primary |
Change in Cognitive flexibility at two months |
Test composed of two parts (Tracks A and Tracks B). The execution time for each of the tests is limited to four minutes or three errors The test score will be obtained through the time spent to finish each part. For speed adjustment, the difference between the completion times of part B and part A will be calculated, in which smaller differences in scores indicate better speed adjustments. |
Baseline and 8-weeks |
|
Secondary |
Change in baseline quality of life time at two months. |
Test: World Health Organization Quality of Life Assessment Bref. The Brazilian version of the World Health Organization Quality of Life Assessment Bref will be utilized in this study. The 26 items produce 4 domains related to Quality of Life; physical (health), psychological, social relationships and environmental and an overall Quality of life and health satisfaction facet. Each item is measured from 1 to 5 on a Likert scale, with varying scale response anchors, where higher values represent higher Quality of life. One example of item is "How much do you enjoy life?", rated on the following response options (1) not at all, (2) a little, (3) a moderate amount, (4) very much, and (5) an extreme amount. |
Baseline and 8-weeks |
|
Secondary |
Maximum isometric voluntary contraction |
To evaluate the Maximum isometric voluntary contraction (MIVC) of the lower extremities, a load cell or extensiometric cell (MK®, CSL / ZL-1 T, MK Controle, Brazil) with a sampling frequency of 1000 Hz will be used. |
Baseline and 8-weeks |
|
Secondary |
1RM test |
To perform the one repetition maximum test (1RM), the knee extension exercise will be used on a BH fitness® Nevada Pro-t extension machine. To perform the test, the volunteer will be asked to extend the knee to form an angle of approximately 180° (final position) and return to the initial position. |
Baseline and 8-weeks |
|
Secondary |
Muscle power |
The evaluation of lower limb muscle power will be performed using the same knee extension machine used in the exercise sessions, starting from the same initial position (90º of kneeling flexion) and reaching the same final position (180º of knee extension) as the test of 1RM. |
Baseline and 8-weeks |
|
Secondary |
Change In Baseline Total body mass at two months |
Dual-engy X-ray absorptiometry (DXA) full body exam (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). |
Baseline and 8-weeks |
|
Secondary |
Change In Baseline lean mass At Two Months |
Dual-engy X-ray absorptiometry (DXA) full body exam (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). |
Baseline and 8-weeks |
|
Secondary |
Change In Baseline bone mineral content At Two Months |
Dual-engy X-ray absorptiometry (DXA) full body exam (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). |
Baseline and 8-weeks |
|
Secondary |
Change In Baseline bone mineral density At Two Months |
Dual-engy X-ray absorptiometry (DXA) full body exam (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). |
Baseline and 8-weeks |
|
Secondary |
Change In Baseline bone loss index throughout life At Two Months |
Dual-engy X-ray absorptiometry (DXA) full body exam (GE Healthcare Lunar Prodigy Advance DXA System, software version 13.31). |
Baseline and 8-weeks |
|
Secondary |
Blood pressure |
minimus® III aneroid tensiometer will be used, which has a maximum error margin of +/-3 mmHg. Systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean blood pressure (MBP) will be calculated. MBP will be obtained with the following mathematical operation: PAD + PAD + PAS / 3 |
Baseline and 8-weeks |
|
Secondary |
Resting heart rate |
For Resting heart rate (HRR) measurement, women will be advised to sit for 3 minutes. After that moment, this variable will be taken manually in the radial or carotid pulse of the right side for 60 seconds. |
Baseline and 8-weeks |
|
Secondary |
Abdominal circumference |
Metallic tape measure |
Baseline and 8-weeks |
|
Secondary |
Number of participants with adverse events or damages |
A self-designed questionnaire consisting of categorical questions (yes or no) will be utilized to assess adverse events. The severity of adverse events will be graded using version 5.0 of the "Common Terminology Criteria for Adverse Events" (CTCAEv5.0). Possible adverse events related to the intervention will be documented in the questionnaire. |
8-weeks |
|
Secondary |
Change in baseline Falls Efficacy Scale-International at to months |
The risk of falling will be assessed by means of the Falls Efficacy Scale-International (FES-I) questionnaire in its Brazilian version, which evaluates 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). |
Baseline and 8-weeks |
|
Secondary |
Changes in baseline active time at two months. |
For the actimetry the Actigraph GT3X-BT accelerometer will be used for a period of eight days. The participant must fill out a sleep diary together with the use of the accelerometer. The ActiLive software will be used to analyze active time (minutes). The sleep diary will be used for possible adjustments in the quantification of the reading variables. The results of the analysis will allow the identification of sleep time and its quality, according to the time of latency and awakenings throughout the night, and whether the participant can maintain a sleep-wake pattern. |
Baseline and 8-weeks |
|
Secondary |
Changes In Baseline Sleep latency At Two Months. |
For the actimetry the Actigraph GT3X-BT accelerometer will be used for a period of eight days. The participant must fill out a sleep diary together with the use of the accelerometer. The ActiLive software will be used to analyze sleep latency (minutes) The sleep diary will be used for possible adjustments in the quantification of the reading variables. The results of the analysis will allow the identification of sleep time and its quality, according to the time of latency and awakenings throughout the night, and whether the participant can maintain a sleep-wake pattern. |
Baseline and 8-weeks |
|
Secondary |
Changes in baseline sleep quality at two months. |
The Pittsburg Sleep Quality Index will be used to evaluate the subjective quality of sleep and the presence of sleep disturbances in a period of four weeks prior to its application. In relation to the score, when the score is less than 5 it indicates the absence of sleep disturbances or a good quality of sleep, and when the sum is greater than 5 points it indicates a poor quality of sleep and possible presence of sleep disturbances. A sum closer to 0 indicates better quality and no sleep disturbance. |
Baseline and 8-weeks |
|
Secondary |
Changes In Baseline Wakefulness after sleep onset At Two Months. |
For the actimetry the Actigraph GT3X-BT accelerometer will be used for a period of eight days. The participant must fill out a sleep diary together with the use of the accelerometer. The ActiLive software will be used to analyze wakefulness after sleep onset (minutes). The sleep diary will be used for possible adjustments in the quantification of the reading variables. The results of the analysis will allow the identification of sleep time and its quality, according to the time of latency and awakenings throughout the night, and whether the participant can maintain a sleep-wake pattern. |
Baseline and 8-weeks |
|
Secondary |
Changes in baseline chronotype at two months. |
Changes in chronotype at baseline and in eight weeks. For the analysis of the chronotype profile, the Horne and Ostberg questionnaire will be used, consisting of 19 questions. It will classify the participants into afternoon, intermediate, and morning. Scores can range from 16-86. Scores of 41 and below indicate "afternoon types"; scores of 59 and above indicate "morning types," and scores between 42-58 indicate "intermediate types." |
Baseline and 8-weeks |
|
Secondary |
Changes In Baseline Total sleep time At Two Months. |
For the actimetry the Actigraph GT3X-BT accelerometer will be used for a period of eight days. The participant must fill out a sleep diary together with the use of the accelerometer. The ActiLive software will be used to analyze total sleep time (minutes) The sleep diary will be used for possible adjustments in the quantification of the reading variables. The results of the analysis will allow the identification of sleep time and its quality, according to the time of latency and awakenings throughout the night, and whether the participant can maintain a sleep-wake pattern. |
Baseline and 8-weeks |
|
Secondary |
Changes In Baseline Sleep efficiency At Two Months. |
For the actimetry the Actigraph GT3X-BT accelerometer will be used for a period of eight days. The participant must fill out a sleep diary together with the use of the accelerometer. The ActiLive software will be used to analyze sleep efficiency (%). The sleep diary will be used for possible adjustments in the quantification of the reading variables. The results of the analysis will allow the identification of sleep time and its quality, according to the time of latency and awakenings throughout the night, and whether the participant can maintain a sleep-wake pattern. |
Baseline and 8-weeks |
|
Secondary |
Changes in baseline sleepiness at two months |
The Epworth Sleepiness Scale subjectively assesses an individual's levels of sleepiness. Higher scores indicate abnormal sleepiness. Scores: 1-6 points (Normal sleep); 7-8 points (Average sleepiness) and 9-24 points (Abnormal sleepiness). |
Baseline and 8-weeks |
|