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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Depressive Symptoms
• Intervention / Treatment: Other: Aquatic Exercises; Other: Watsu

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo GS Carvalho, PhD; Phone Number: +5587999832015; Email: rodrigocarvalhofisio@gmail.com
• Study Contact Backup: Name: Rodrigo GS Carvalho, PhD; Phone Number: +558721016856; Email: rodrigo.carvalho@univasf.edu.br

Study Locations

• Brazil
  • Pernambuco
    • Petrolina, Pernambuco, Brazil, 56304917
      • Recruiting
      • Physical Education College
      • Contact: Rodrigo GS Carvalho, PhD; Phone Number: 8721016856; Email: rodrigo.carvalho@univasf.edu.br
      • Contact: Rodrigo GS Carvalho, PhD; Phone Number: 8721016856; Email: rodrigocarvalhofisio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Aquatic Exercises; twice a week, lasting 50 minutes, for two months.; Other Names: Aquatic Exercises (AE)
Active Comparator: 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.	Other: Watsu; twice a week, lasting 50 minutes, for two months.; Other Names: Water Shiatsu (WS)
No Intervention: Control; The control group will not receive any of these treatments (aquatic exercises and Watsu).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Beck Depression Inventory (better 0-63 worse points)	change depression at 8 weeks and follow-up at 12 weeks
Anxiety	Beck Anxiety Inventory (better 0-63 worse points)	change anxiety at 8 weeks and follow-up at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse >34)	change stress at 8 weeks and follow-up at 12 weeks
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
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)	change sleep quality at 8 weeks and follow-up at 12 weeks
Life Style Scale	Fantastic Life Style Scale (worse 0 - better 100)	change life style at 8 weeks and follow-up at 12 weeks
Cognitive	Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)	change cognitive at 8 weeks and follow-up at 12 weeks
Functionally	Six-minute Walk Test (6m-WT)	change functionally at 8 weeks and follow-up at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement Perception	Improvement Perception Scale (0-7)	pos (8 week)

Collaborators and Investigators

• Sponsor: Universidade Federal do vale do São Francisco
• Investigators: Principal Investigator: Rodrigo GS Carvalho, PhD, Physical Education College / UNIVASF

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: depression; anxiety; hydrotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: AE-Mental

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study Protocol, Randomized Clinical Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No