NCT07156708

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Sep 2025Aug 2027

First Submitted

Initial submission to the registry

August 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

August 26, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

Physical exercisePhysical activityDual-task trainingWater-based exerciseCognitive functionPhysical fitnessMental healthSleep qualityQuality of lifeCardiovascular parameters

Outcome Measures

Primary Outcomes (2)

  • Objective cognitive function - Digit Span Test

    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.

    Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)

  • Objective cognitive function - Controlled Oral Word Association Test

    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.

    Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)

Secondary Outcomes (14)

  • Objective cognitive function - Trail Making Test (TMT)

    Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)

  • Self-perception of cognitive function

    Baseline (week 0), post-intervention (week 13), and 12-week follow-up (week 25)

  • Aerobic fitness

    Baseline (week 0) to post-training (week 13)

  • Lower limb strength

    Baseline (week 0) to post-training (week 13)

  • Upper limb strength

    Baseline (week 0) to post-training (week 13)

  • +9 more secondary outcomes

Other Outcomes (11)

  • Cognitive status

    Baseline (week 0)

  • Sociodemographic and clinical characteristics

    Baseline (week 0)

  • Body mass

    Baseline (week 0) to post-training (week 13)

  • +8 more other outcomes

Study Arms (3)

Aquatic aerobic exercise program combined with cognitive tasks

EXPERIMENTAL
Other: Aquatic aerobic exercise programOther: Cognitive tasks

Conventional aquatic aerobic exercise program

EXPERIMENTAL
Other: Aquatic aerobic exercise program

Control group

NO INTERVENTION

Interventions

The aquatic exercise sessions include the following exercises: butt kick, frontal kick, cross-country skiing, and stationary running. These exercises are commonly used in water aerobics classes and provide controlled osteoarticular impact, being safe for older women (Alberton et al., 2019). Training intensity is prescribed using Borg's 6-20 rating of perceived exertion (RPE) scale. The adopted strategy is based on interval training, which alternates between high-intensity effort and low-intensity active recovery phases. Each block consists of 4 minutes of effort (RPE 13 - 15), with one minute for each exercise (butt kick, frontal kick, cross-country skiing, and stationary running) followed by 1 minute of active recovery (RPE 11), performed with stationary running. To facilitate monitoring, an RPE scale (measuring 0.90 × 1.20 m) is fixed to the outside of the pool, in front of the participants.

Aquatic aerobic exercise program combined with cognitive tasksConventional aquatic aerobic exercise program

This group performs the same aerobic training protocol used by the conventional aquatic program group. Additionally, cognitive tasks are performed during the active recovery phases. Cognitive training encompasses different domains of cognition in all sessions, including semantic fluency, processing speed, cognitive flexibility, inhibitory control, memory, attention, and reasoning. The exercises vary in each class, with progression in complexity in each mesocycle.

Aquatic aerobic exercise program combined with cognitive tasks

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Educação Física e Fisioterapia

Pelotas, Rio Grande do Sul, 96055-630, Brazil

RECRUITING

Related Publications (13)

  • Foster C, Florhaug JA, Franklin J, Gottschall L, Hrovatin LA, Parker S, Doleshal P, Dodge C. A new approach to monitoring exercise training. J Strength Cond Res. 2001 Feb;15(1):109-15.

    PMID: 11708692BACKGROUND
  • Sao-Joao TM, Rodrigues RC, Gallani MC, Miura CT, Domingues Gde B, Godin G. [Cultural adaptation of the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire]. Rev Saude Publica. 2013 Jun;47(3):479-87. doi: 10.1590/s0034-8910.2013047003947. Portuguese.

    PMID: 24346560BACKGROUND
  • Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. [Suggestions for utilization of the mini-mental state examination in Brazil]. Arq Neuropsiquiatr. 2003 Sep;61(3B):777-81. doi: 10.1590/s0004-282x2003000500014. Epub 2003 Oct 28. Portuguese.

    PMID: 14595482BACKGROUND
  • Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.

    PMID: 10881154BACKGROUND
  • Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9.

    PMID: 21145786BACKGROUND
  • Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.

    PMID: 8731275BACKGROUND
  • Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

    PMID: 8737210BACKGROUND
  • STROOP, J. R. Studies of interference in serial verbal reactions. Journal of Experimental Psychology, v. 18, n. 6, p. 643-662, 1935.

    BACKGROUND
  • de Paula JJ, Costa DS, Miranda DM, Romano-Silva MA. Brazilian version of the Cognitive Failures Questionnaire (CFQ): cross-cultural adaptation and evidence of validity and reliability. Braz J Psychiatry. 2018 Jul-Sep;40(3):312-315. doi: 10.1590/1516-4446-2017-2227. Epub 2017 Dec 11.

    PMID: 29236920BACKGROUND
  • Carvalho GA, Caramelli P. Normative data for middle-aged Brazilians in Verbal Fluency (animals and FAS), Trail Making Test (TMT) and Clock Drawing Test (CDT). Dement Neuropsychol. 2020 Jan-Mar;14(1):14-23. doi: 10.1590/1980-57642020dn14-010003.

    PMID: 32206193BACKGROUND
  • Ross TP, Calhoun E, Cox T, Wenner C, Kono W, Pleasant M. The reliability and validity of qualitative scores for the Controlled Oral Word Association Test. Arch Clin Neuropsychol. 2007 May;22(4):475-88. doi: 10.1016/j.acn.2007.01.026. Epub 2007 Feb 20.

    PMID: 17317094BACKGROUND
  • Schroeder RW, Twumasi-Ankrah P, Baade LE, Marshall PS. Reliable Digit Span: a systematic review and cross-validation study. Assessment. 2012 Mar;19(1):21-30. doi: 10.1177/1073191111428764. Epub 2011 Dec 6.

    PMID: 22156721BACKGROUND
  • Alberton CL, Nunes GN, Rau DGDS, Bergamin M, Cavalli AS, Pinto SS. Vertical Ground Reaction Force During a Water-Based Exercise Performed by Elderly Women: Equipment Use Effects. Res Q Exerc Sport. 2019 Dec;90(4):479-486. doi: 10.1080/02701367.2019.1620910. Epub 2019 Jun 11.

    PMID: 31184984BACKGROUND

MeSH Terms

Conditions

Motor ActivityPsychological Well-BeingSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Cristine L Alberton, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding is applied to outcome assessors and data analysts responsible for evaluating both primary and secondary outcomes. However, due to the nature of the interventions, blinding is not feasible for the staff conducting the exercise sessions or the participants. To maintain assessor blinding, participants are instructed not to disclose their group allocation or discuss intervention details during outcome assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This trial is a randomized clinical trial employing a 1:1:1 allocation ratio. It was designed as a superiority trial with three parallel groups and blinded to outcome assessors and data analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 5, 2025

Study Start

September 5, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Individual participant data can be made available by the Trial Coordinator upon reasonable request.

Locations