Aquatic Exercises Combined With Cognitive Tasks for Older Adults
NCT07156708, Not applicable, Recruiting, Federal University of Pelotas
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Aquatic Exercises Combined With Cognitive Tasks for Older Adults | ClinicalTrials.gov |
| NCT number | NCT07156708 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 98 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Federal University of Pelotas | ClinicalTrials.gov |
| Conditions | Aging | ClinicalTrials.gov |
| Interventions | Aquatic aerobic exercise program, Cognitive tasks | ClinicalTrials.gov |
| First posted | 2025-09-05 | ClinicalTrials.gov |
| Last updated | 2025-09-09 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective cognitive function - Digit Span Test | Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25) | The Digit Span Test is used to assess working memory and attention span (Schroeder et al., 2012). The Digit Span Test requires participants to verbally recall a sequence of numbers dictated by the examiner. The test begins with three numbers ranging from 0 to 9, read at 1-second intervals, which participants must remember in the correct order. The sequence increases by one digit if pronounced correctly. If participants fail to recall the correct sequence twice in a row, the test ends. The number of digits correctly recalled is recorded as the test result, with a higher score indicating better performance. | ClinicalTrials.gov |
| Primary | Objective cognitive function - Controlled Oral Word Association Test | Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25) | The Controlled Oral Word Association Test (COWAT) is used to assess verbal fluency, working memory, and inhibitory control (Ross et al., 2007). In this test, participants must say as many words as possible that start with the letters "F," "A," and "S" within 1 minute for each letter. Proper names, repeated words, and variations in gender, number, and conjugation are not considered. A higher number of words in each test indicates better verbal fluency. | ClinicalTrials.gov |
| Secondary | Objective cognitive function - Trail Making Test (TMT) | Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25) | The validated version of the Trail Making Test (TMT) for the Brazilian population is used to assess aspects of objective cognitive function (Carvalho \& Caramelli, 2020). In the first part of the instrument (TMT-A), which measures visual attention and processing speed, participants must draw a line connecting the numbers 1 to 25 in ascending order. In the second part (TMT-B), which measures cognitive flexibility and executive function, participants connect numbers (1-13) and letters (A-L) in an interleaved numerical and alphabetical order. Participants are instructed to maintain pencil-and-paper contact throughout the test, and shorter completion times indicate better performance. | ClinicalTrials.gov |
| Secondary | Self-perception of cognitive function | Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25) | The Brazilian version of the Cognitive Failures Questionnaire (CFQ) is used to measure the frequency of cognitive failures in everyday life, such as lapses in attention, memory problems, and failures in executing intentional actions (Paula et al., 2017). The questionnaire consists of 25 self-administered items, with responses on a Likert-type scale from 0 to 4, which assess the frequency of cognitive failures in different everyday contexts. The total score ranges from 0 to 100 points, with higher scores indicating a greater perceived frequency of cognitive failures and, therefore, poorer self-perception of cognitive function. | ClinicalTrials.gov |
| Secondary | Aerobic fitness | Baseline (week 0) to post-training (week 13) | The 6-minute Walk Test (6MWT) is performed to measure aerobic fitness. The course proposed in the original test is 45.72 m rectangular. The course will be adapted for a straight line of 30 m in length, demarcated with cones every 3 m. Participants are instructed to walk for 6 minutes in a flat 30m course, where the total distance walked "as fast as possible" is assessed | ClinicalTrials.gov |
| Secondary | Lower limb strength | Baseline (week 0) to post-training (week 13) | The 30-s Chair-Stand test is performed to measure the strength of the lower limbs. Participants are instructed to sit and stand up from a chair 43 cm high from the seat, without the aid of the upper limbs, as many times as possible for 30 s. The total number of complete repetitions performed within the 30 seconds is recorded as the result, with higher values indicating greater lower body strength. | ClinicalTrials.gov |
| Secondary | Upper limb strength | Baseline (week 0) to post-training (week 13) | The Arm Curl test is performed to measure the strength of the upper limbs. Starting at full elbow extension and holding a 2 kg dumbbell in each hand, participants are instructed to perform the maximal number of elbow crunches over the full range of motion for 30 s. The test is performed with both upper limbs. The total number of complete repetitions performed within the 30 s is recorded as the result, with higher values indicating greater upper body strength. | ClinicalTrials.gov |
| Secondary | Lower limb flexibility | Baseline (week 0) to post-training (week 13) | The Sit-and-Reach test is performed using a Wells Bench to assess lower limb flexibility, particularly of the hamstring and lower back muscles. Participants sit barefoot on the floor with their legs extended and together, knees fully extended, and the soles of the feet flat against the front of the bench. With arms extended and hands overlapping, they slowly bend forward from the hips, sliding their hands along the measurement scale on the bench, without flexing the knees or using compensatory movements. The maximum reach is held for approximately two seconds, and the greatest distance reached in centimeters in three attempts is recorded. | ClinicalTrials.gov |
| Secondary | Agility and dynamic balance | Baseline (week 0) to post-training (week 13) | The Timed Up and Go (TUG) test is performed to measure agility and dynamic balance. Participants are instructed to get up from the chair (43 cm), turn around a marker that will be 3m, and return to the starting position. The shortest time of the two attempts is considered the result. | ClinicalTrials.gov |
| Secondary | Dual-task performance | Baseline (week 0) to post-training (week 13) | Dual-task performance involves simultaneously performing the TUG test and a cognitive task. Participants are instructed to do the TUG while reciting alternating letters (e.g., A, C, E, etc.). The time taken for the TUG and the number of correctly recited letters are recorded as test results. | ClinicalTrials.gov |
| Secondary | Blood pressure | Baseline (week 0) to post-training (week 13) | Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements are obtained using calibrated and automated oscillometric devices (HEM-7320, OMRON, China). Participants are kept in a calm environment for 5 min, and then measurements are performed in both arms of the participant. Three measurements, with an interval of 1 to 2 min, are taken in the arm with the highest initial value. The average of the three measurements is considered the subject's office blood pressure. | ClinicalTrials.gov |
| Secondary | Blood pressure reactivity | Baseline (week 0) to post-training (week 13) | Blood pressure reactivity is measured as the difference between values recorded during a mental stressor and those obtained at rest. The Stroop Test (Stroop, 1935) is used to induce mental stress, presented via a video on a screen in front of the participant for three minutes. Every two seconds, a visual stimulus consisting of a word written in a specific color will appear, with the color of the word and its meaning being incongruent (for example, the word "blue" written in red). The participant must respond verbally and as quickly as possible to the color of the letters, ignoring the meaning of the word. Throughout the test, systolic and diastolic blood pressure are measured by the auscultatory method, using a stethoscope and a calibrated aneroid sphygmomanometer, with one reading every minute, for a total of three readings. The reference arm is the same one used for resting BP assessments. After completing the test, participants are asked to rate their perceived stress level using a | ClinicalTrials.gov |
| Secondary | Heart rate variability | Baseline (week 0) to post-training (week 13) | Heart rate variability (HRV) is measured with participants seated and resting for 10 minutes, during which time their heart rate is continuously recorded using the Polar H10 chest sensor, a validated and widely used device for HRV analysis. Data collection takes place in a quiet environment, with a controlled temperature between 24°C and 26°C. Data is collected via Bluetooth and stored in the Polar Flow app, later exported in a compatible format (.txt or .csv). The final five minutes of the resting period are considered for analysis, as they offer greater physiological stability. Data are processed in Kubios HRV® software, with automatic artifact correction using a low threshold filter. HRV analysis follows the recommendations of the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology (1996), considering time-domain parameters such as SDNN (Standard Deviation of NN Intervals), which reflects the global variability of autonomi | ClinicalTrials.gov |
| Secondary | Depressive and anxiety symptoms | Baseline (week 0) to post-training (week 13) | The validated version of the HADS for the Brazilian population is used to assess depressive and anxious symptoms (Botega et al., 1995). It is an instrument composed of 14 items, seven of which form the anxiety subscale and the other seven the depression subscale, allowing the assessment of symptoms in the previous week. Each HADS item has four response options ranging from 0 to 3, reaching a maximum of 21 points in each subscale. Participants are instructed to answer the questions based on the last 7 days. Based on the final score of each subscale, participants are categorized as having symptoms of anxiety or depression as "unlikely" (0 to 7 points), "possible" (8 to 11 points), and "probable" (12 to 21 points). Higher scores indicate more severe symptoms and a worse perceived emotional state. | ClinicalTrials.gov |
| Secondary | Sleep quality | Baseline (week 0) to post-training (week 13) | The validated version of the Pittsburgh Sleep Quality Index (PSQI) for the Brazilian population is used to assess subjective sleep quality and related disorders (Bertolazi et al., 2011). The questionnaire consists of 19 items, grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping medications, and daytime dysfunction. Each component is scored from 0 (no difficulty) to 3 (severe difficulty), and the sum of the scores results in an overall score ranging from 0 to 21; scores greater than 5 indicate poor sleep quality. | ClinicalTrials.gov |
| Secondary | Self-reported quality of life | Baseline (week 0) to post-training (week 13) | Quality of life is assessed using the WHOQOL-BREF questionnaire, developed by the World Health Organization and previously validated in the Brazilian population (Fleck et al., 2000). The WHOQOL-BREF comprises 26 items divided into four domains: physical, psychological, social relationships, and environment. This instrument is self-administered, with a 5-point Likert scale, and produces standardized scores ranging from 0 to 100, with higher values indicating better perceived quality of life. | ClinicalTrials.gov |
| Other | Cognitive status | Baseline (week 0) | The validated version of the Mini-Mental State Examination (MMSE) (Brucki et al., 2003) for the Brazilian population is used to screen for cognitive decline, and in this study, it is also used to stratify randomization. The questionnaire is divided into two sections: the first, with a maximum score of 21, requires vocal responses regarding temporal and spatial orientation, memory, and attention; the second, with a maximum score of 9, assesses the ability to name, follow commands, write, and copy a polygon. The maximum total score is 30 points, and the test is not timed. Participants' cognitive function is classified based on cutoff points adjusted for education, as proposed by Brucki et al. (2003). The score is formed by the sum of the items answered correctly; the higher the score, the better the cognitive function. | ClinicalTrials.gov |
| Other | Sociodemographic and clinical characteristics | Baseline (week 0) | Sociodemographic data, health history, medical conditions, and medication use are collected using a standardized questionnaire before the intervention. | ClinicalTrials.gov |
| Other | Body mass | Baseline (week 0) to post-training (week 13) | Body mass measurements are performed using a digital scale with a stadiometer (Welmy, Santa Bárbara d'Oeste - São Paulo, Brazil). Body mass is measured in kilograms. | ClinicalTrials.gov |
| Other | Height | Baseline (week 0) to post-training (week 13) | Height measurements are performed using a digital scale with a stadiometer (WELMY, Santa Bárbara d'Oeste - São Paulo, Brazil). Height is measured in meters. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 13
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 8731275 | BACKGROUND | PubMed |
| 8737210 | BACKGROUND | PubMed |
| 10881154 | BACKGROUND | PubMed |
| 11708692 | BACKGROUND | PubMed |
| 14595482 | BACKGROUND | PubMed |
| 17317094 | BACKGROUND | PubMed |
| 21145786 | BACKGROUND | PubMed |
| 22156721 | BACKGROUND | PubMed |
| 24346560 | BACKGROUND | PubMed |
| 29236920 | BACKGROUND | PubMed |
| 31184984 | BACKGROUND | PubMed |
| 32206193 | BACKGROUND | PubMed |
| 41794695 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)