Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.

NCT ID: NCT04100850

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2023-12-31

Brief Summary

Objective: To compare the effectiveness between aquatic exercises (water aerobics versus Watsu) versus control groups, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression.

Detailed Description

Introduction: Considered as the "21st century disease", depression is a silent disease that stands out for its high prevalence and high morbidity, leading to serious consequences. With treatments made in aquatic environment, among them the Water aerobics and Watsu. Objective: To compare the effectiveness between aquatic exercises versus Watsu and versus control group, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression. Methods: This study will be a randomized clinical trial, which will last for two months with a follow-up of one month. All participants will be assessed using specific questionnaires for each outcome and an Improvement Perception Scale (MS). Seventy eight (78) patients with a medical diagnosis of depression, aged 18 to 60 years, who will be allocated to three groups (26 patients for each group) will be treated. GROUP 1: Aquatic exercises (aerobic and resistance), collective session, twice a week lasting 50 min; GROUP 2: Watsu (water shiatsu), individual session, twice a week lasting 50 min; Group 3: control, people with depression. Statistical analysis: Normality distribution will be by Shapiro-Wilk test. For comparisons of the means between and within the outcome groups will be used through Generalized Estimation Equations, with its own syntax, linear distribution and, when necessary, multiple comparisons will be performed using the Bonferroni test to identify differences. Will be calculated for comparisons between the final and initial moments and initial follow-up in each group, statistics such as: mean difference (95% CI), standard deviation of the difference, effect size (Cohen's d). The statistical significance adopted was 5% and the analyzes were performed using the statistical programs SPSS 22.0 and R 3.2.4. The intention-to-treat analysis will be performed.

Conditions

Depression; Depressive Symptoms; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aquatic Exercises

Aquatic Exercises (AE) are water aerobics exercises and resistance exercises, classes will be supervised by a Physical Educator, in collective sessions of up to 30 people per class, twice a week, lasting 50 minutes, for two months.

Group Type: EXPERIMENTAL

Aquatic Exercises

Intervention Type: OTHER

twice a week, lasting 50 minutes, for two months.

Watsu

The Watsu (water shiatsu) will be applied by a physical therapist, in individual sessions, twice a week, lasting 50 minutes, for two months in a warn pool (± 34°C). Watsu in particular prescribes transition of movements, once they are instituted, the therapist can create and adapt according to the limitations and restrictions that are encountered.

Group Type: ACTIVE_COMPARATOR

Watsu

Intervention Type: OTHER

twice a week, lasting 50 minutes, for two months.

Control

The control group will not receive any of these treatments (aquatic exercises and Watsu).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aquatic Exercises

twice a week, lasting 50 minutes, for two months.

Intervention Type: OTHER

Watsu

twice a week, lasting 50 minutes, for two months.

Intervention Type: OTHER

Other Intervention Names

Aquatic Exercises (AE); Water Shiatsu (WS)

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 60 years old;
• Sedentary and who have not had physical therapy and physical activity in the last three months;
• Clinical and cognitive conditions for performing pool activities and moderate aerobic exercise;
• Who have not undergone high complexity surgical procedures in the last six months; no neuro-musculosqueletal diseases;
• No contraindications to exercise; such as: urinary and / or fecal incontinence and dermatological diseases;
• Individuals with a medical diagnosis of depression.

Exclusion Criteria

• If they have up to three absences during the intervention period;
• If they have any adverse effects, such as: allergy or dermatitis;
• Unable to continue study due to change of address or hospitalization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do vale do São Francisco

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Gustavo da Silva Carvalho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo GS Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

Physical Education College / UNIVASF

Locations

Physical Education College

Petrolina, Pernambuco, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rodrigo GS Carvalho, PhD

Role: CONTACT

rodrigocarvalhofisio@gmail.com

+5587999832015

Rodrigo GS Carvalho, Phd

Role: CONTACT

rodrigo.carvalho@univasf.edu.br

+558721016856

Facility Contacts

Rodrigo GS Carvalho, PhD

Role: primary

rodrigo.carvalho@univasf.edu.br

8721016856

Rodrigo GS Carvalho, PhD

Role: backup

rodrigocarvalhofisio@gmail.com

8721016856

Other Identifiers

AE-Mental

Identifier Type: -

Identifier Source: org_study_id