Clinical trial NCT04100850: Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.
Official title: Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Depressive Symptoms
Anxiety
Keywords: hydrotherapy
depression
anxiety
Lead sponsor: Universidade Federal do vale do São Francisco
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Watsu, Aquatic Exercises, Control
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression
timeFrame: change depression at 8 weeks and follow-up at 12 weeks
measure: Anxiety
timeFrame: change anxiety at 8 weeks and follow-up at 12 weeks
Secondary outcomes:
measure: Stress
timeFrame: change stress at 8 weeks and follow-up at 12 weeks
measure: Quality of Life Questionnaire
timeFrame: change quality of live at 8 weeks and follow-up at 12 weeks
measure: Sleep Quality
timeFrame: change sleep quality at 8 weeks and follow-up at 12 weeks
measure: Life Style Scale
timeFrame: change life style at 8 weeks and follow-up at 12 weeks
measure: Cognitive
timeFrame: change cognitive at 8 weeks and follow-up at 12 weeks
measure: Functionally
timeFrame: change functionally at 8 weeks and follow-up at 12 weeks
Other outcomes:
measure: Improvement Perception
timeFrame: pos (8 week)
Locations:
city: Petrolina
country: Brazil
facility: Physical Education College
state: Pernambuco
Study officials:
affiliation: Physical Education College / UNIVASF
name: Rodrigo GS Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: