DepressionAEforMHNCT04100850
Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.
A study testing Aquatic Exercises and Watsu in people with Depression and Depressive Symptoms, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Depressive Symptoms, Anxiety
- What is being tested?
- Aquatic Exercises and Watsu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physical Education College
Petrolina, Pernambuco, 56304917
Rodrigo GS Carvalho, PhD, 8721016856, rodrigo.carvalho@univasf.edu.br
Rodrigo GS Carvalho, PhD, 8721016856, rodrigocarvalhofisio@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Aquatic Exercises, Watsu
- Keywords
- hydrotherapy, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExercisesOther
Also called Aquatic Exercises (AE)
twice a week, lasting 50 minutes, for two months.
WatsuOther
Also called Water Shiatsu (WS)
twice a week, lasting 50 minutes, for two months.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Exercises | Experimental | 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. Receives: Other: Aquatic Exercises |
| Watsu | Active comparator | 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. Receives: Other: Watsu |
| Control | No intervention | The control group will not receive any of these treatments (aquatic exercises and Watsu). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Beck Depression Inventory (better 0-63 worse points)
Measured: change depression at 8 weeks and follow-up at 12 weeks
Anxiety
Beck Anxiety Inventory (better 0-63 worse points)
Measured: change anxiety at 8 weeks and follow-up at 12 weeks
Secondary outcomes (6)
Stress
Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse >34)
Measured: 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)
Measured: change quality of live at 8 weeks and follow-up at 12 weeks
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)
Measured: change sleep quality at 8 weeks and follow-up at 12 weeks
Life Style Scale
Fantastic Life Style Scale (worse 0 - better 100)
Measured: change life style at 8 weeks and follow-up at 12 weeks
Cognitive
Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)
Measured: change cognitive at 8 weeks and follow-up at 12 weeks
Functionally
Six-minute Walk Test (6m-WT)
Measured: change functionally at 8 weeks and follow-up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Watsu, Aquatic Exercises, Control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco
- Investigators
- Rodrigo GS Carvalho, PhD, Principal investigator, Physical Education College / UNIVASF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100850
- Sponsor's protocol ID
- AE-Mental
- Acronym
- AEforMH
- Status last verified
- May 2023
- First submitted
- 20 Sep 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol, Randomized Clinical Trial
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04100850
- Acronym / sponsor ID
- AEforMH / AE-Mental
- Conditions
- Depression, Depressive Symptoms, Anxiety
- Keywords
- hydrotherapy, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Watsu, Aquatic Exercises, Control
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercises | Experimental | Other: Aquatic ExercisesAquatic 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. |
| Watsu | Active comparator | Other: WatsuThe 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. |
| Control | No intervention | –The control group will not receive any of these treatments (aquatic exercises and Watsu). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic ExercisesAlso: Aquatic Exercises (AE)twice a week, lasting 50 minutes, for two months. | Other | Aquatic Exercises |
| WatsuAlso: Water Shiatsu (WS)twice a week, lasting 50 minutes, for two months. | Other | Watsu |
Primary outcome
Depression
Time frame: change depression at 8 weeks and follow-up at 12 weeks
Beck Depression Inventory (better 0-63 worse points)
Anxiety
Time frame: change anxiety at 8 weeks and follow-up at 12 weeks
Beck Anxiety Inventory (better 0-63 worse points)
6 secondary outcomes
Stress
Time frame: change stress at 8 weeks and follow-up at 12 weeks
Quality of Life Questionnaire
Time frame: change quality of live at 8 weeks and follow-up at 12 weeks
Sleep Quality
Time frame: change sleep quality at 8 weeks and follow-up at 12 weeks
Life Style Scale
Time frame: change life style at 8 weeks and follow-up at 12 weeks
Cognitive
Time frame: change cognitive at 8 weeks and follow-up at 12 weeks
Functionally
Time frame: change functionally at 8 weeks and follow-up at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No. Study Protocol, Randomized Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo GS Carvalho, PhD principal investigator
Physical Education College / UNIVASF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercises and Watsu in people with Depression and Depressive Symptoms, run by Universidade Federal do vale do São Francisco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo GS Carvalho, PhD (+5587999832015, rodrigocarvalhofisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: change depression at 8 weeks and follow-up at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.