Aquatic Exercises Combined With Cognitive Tasks for Older Adults

Not Applicable

Recruiting

• Conditions: Aging

• Registration Number: NCT07156708
• Lead Sponsor: Federal University of Pelotas

Brief Summary

The aquatic environment has characteristics that favor the adherence of older adults to exercise programs, and studies have shown that programs in this setting are effective in enhancing various aspects of physical fitness as well as cognitive function in this population. Research has explored whether incorporating cognitive tasks into an aquatic exercise program could offer additional benefits, but it remains uncertain whether this approach leads to greater improvements in cognitive function compared to aquatic exercises alone. The present protocol reports the WaterCog Study, which aims to evaluate the effects of an aquatic aerobic exercise program combined with cognitive tasks, compared to a conventional aquatic aerobic exercise program and a control group, on cognitive function and other health-related outcomes in older adults. This trial is a randomized, single-blinded, three-arm, parallel, superiority trial. A total of 98 older adults are randomized into one of three groups: 1) an aquatic aerobic exercise program combined with cognitive tasks, 2) a conventional aquatic aerobic exercise program, and 3) a control group. Participants in both exercise groups complete a 12-week exercise program with two weekly sessions on non-consecutive days. The primary outcome is cognitive function, while secondary outcomes include physical function, cardiovascular, and psychosocial parameters. Outcomes are measured at baseline, post-intervention, and at the 12-week follow-up after the end of the intervention period. The analysis plan will employ an intention-to-treat approach and per-protocol criteria. The conceptual hypothesis of the study is that both training programs will significantly improve the investigated outcomes compared to the control group. Additionally, it is expected that aquatic exercises with cognitive tasks will promote additional benefits in cognitive function, with similar gains in physical function, cardiovascular, and psychosocial parameters compared to conventional aquatic aerobic exercises in post-intervention and follow-up measures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-02
• Study Start: 2025-09-05
• Study First Posted: 2025-09-05
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 98

Inclusion Criteria

• Older women aged 60 and 75 years;
• Being physically inactive, meaning not participating in physical exercise for at least six months (regular exercise is defined as engaging in any physical training for a minimum of 20 minutes on two or more days a week).

Exclusion Criteria

• History of cardiovascular disease (except controlled hypertension);
• Osteoarticular limitations for the practice of exercises;
• Being illiterate due to the self-completion questionnaires and the characteristics of the intervention;
• Diagnosis of dementia, schizophrenia, or major depressive disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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.
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.
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.

Trial Locations

Locations (1)

Escola Superior de Educação Física e Fisioterapia; 🇧🇷 Pelotas, Rio Grande do Sul, Brazil