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

Depression Clinical Trial

— AEforMH  

Official title:

Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100850
• Other study ID #: AE-Mental
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Universidade Federal do vale do São Francisco
• Contact: Rodrigo GS Carvalho, PhD
• Phone: +5587999832015
• Email: rodrigocarvalhofisio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

Other:
• Aquatic Exercises
twice a week, lasting 50 minutes, for two months.
• Watsu
twice a week, lasting 50 minutes, for two months.

Locations

Country	Name	City	State
Brazil	Physical Education College	Petrolina	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do vale do São Francisco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement Perception	Improvement Perception Scale (0-7)	pos (8 week)
Primary	Depression	Beck Depression Inventory (better 0-63 worse points)	change depression at 8 weeks and follow-up at 12 weeks
Primary	Anxiety	Beck Anxiety Inventory (better 0-63 worse points)	change anxiety at 8 weeks and follow-up at 12 weeks
Secondary	Stress	Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse >34)	change stress at 8 weeks and follow-up at 12 weeks
Secondary	Quality of Life Questionnaire	12-Item Short-Form Health Survey (SF-12) (worse 0 - better 100)	change quality of live at 8 weeks and follow-up at 12 weeks
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)	change sleep quality at 8 weeks and follow-up at 12 weeks
Secondary	Life Style Scale	Fantastic Life Style Scale (worse 0 - better 100)	change life style at 8 weeks and follow-up at 12 weeks
Secondary	Cognitive	Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)	change cognitive at 8 weeks and follow-up at 12 weeks
Secondary	Functionally	Six-minute Walk Test (6m-WT)	change functionally at 8 weeks and follow-up at 12 weeks