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

Primary Purpose

Depression, Depressive Symptoms, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aquatic Exercises
Watsu
Sponsored by
Universidade Federal do vale do São Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring hydrotherapy, depression, anxiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Education CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Aquatic Exercises

Watsu

Control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Depression
Beck Depression Inventory (better 0-63 worse points)
Anxiety
Beck Anxiety Inventory (better 0-63 worse points)

Secondary Outcome Measures

Stress
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse >34)
Quality of Life Questionnaire
12-Item Short-Form Health Survey (SF-12) (worse 0 - better 100)
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)
Life Style Scale
Fantastic Life Style Scale (worse 0 - better 100)
Cognitive
Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)
Functionally
Six-minute Walk Test (6m-WT)

Full Information

First Posted
September 20, 2019
Last Updated
May 9, 2023
Sponsor
Universidade Federal do vale do São Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04100850
Brief Title
Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.
Acronym
AEforMH
Official Title
Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do vale do São Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Symptoms, Anxiety
Keywords
hydrotherapy, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Watsu, Aquatic Exercises, Control
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Watsu
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not receive any of these treatments (aquatic exercises and Watsu).
Intervention Type
Other
Intervention Name(s)
Aquatic Exercises
Other Intervention Name(s)
Aquatic Exercises (AE)
Intervention Description
twice a week, lasting 50 minutes, for two months.
Intervention Type
Other
Intervention Name(s)
Watsu
Other Intervention Name(s)
Water Shiatsu (WS)
Intervention Description
twice a week, lasting 50 minutes, for two months.
Primary Outcome Measure Information:
Title
Depression
Description
Beck Depression Inventory (better 0-63 worse points)
Time Frame
change depression at 8 weeks and follow-up at 12 weeks
Title
Anxiety
Description
Beck Anxiety Inventory (better 0-63 worse points)
Time Frame
change anxiety at 8 weeks and follow-up at 12 weeks
Secondary Outcome Measure Information:
Title
Stress
Description
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse >34)
Time Frame
change stress at 8 weeks and follow-up at 12 weeks
Title
Quality of Life Questionnaire
Description
12-Item Short-Form Health Survey (SF-12) (worse 0 - better 100)
Time Frame
change quality of live at 8 weeks and follow-up at 12 weeks
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)
Time Frame
change sleep quality at 8 weeks and follow-up at 12 weeks
Title
Life Style Scale
Description
Fantastic Life Style Scale (worse 0 - better 100)
Time Frame
change life style at 8 weeks and follow-up at 12 weeks
Title
Cognitive
Description
Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)
Time Frame
change cognitive at 8 weeks and follow-up at 12 weeks
Title
Functionally
Description
Six-minute Walk Test (6m-WT)
Time Frame
change functionally at 8 weeks and follow-up at 12 weeks
Other Pre-specified Outcome Measures:
Title
Improvement Perception
Description
Improvement Perception Scale (0-7)
Time Frame
pos (8 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo GS Carvalho, PhD
Phone
+5587999832015
Email
rodrigocarvalhofisio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo GS Carvalho, Phd
Phone
+558721016856
Email
rodrigo.carvalho@univasf.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Organizational Affiliation
Physical Education College / UNIVASF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Education College
City
Petrolina
State/Province
Pernambuco
ZIP/Postal Code
56304917
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigo.carvalho@univasf.edu.br
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigocarvalhofisio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study Protocol, Randomized Clinical Trial

Learn more about this trial

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

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