NCT04100850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

September 20, 2019

Last Update Submit

May 9, 2023

Conditions

Keywords

hydrotherapydepressionanxiety

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Stress

    change stress at 8 weeks and follow-up at 12 weeks

  • Quality of Life Questionnaire

    change quality of live at 8 weeks and follow-up at 12 weeks

  • Sleep Quality

    change sleep quality at 8 weeks and follow-up at 12 weeks

  • Life Style Scale

    change life style at 8 weeks and follow-up at 12 weeks

  • Cognitive

    change cognitive at 8 weeks and follow-up at 12 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Improvement Perception

    pos (8 week)

Study Arms (3)

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.

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.

Other: Watsu

Control

NO INTERVENTION

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

Interventions

twice a week, lasting 50 minutes, for two months.

Also known as: Aquatic Exercises (AE)
Aquatic Exercises
WatsuOTHER

twice a week, lasting 50 minutes, for two months.

Also known as: Water Shiatsu (WS)
Watsu

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Education College

Petrolina, Pernambuco, 56304917, Brazil

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Rodrigo GS Carvalho, PhD

    Physical Education College / UNIVASF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo GS Carvalho, PhD

CONTACT

Rodrigo GS Carvalho, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Watsu, Aquatic Exercises, Control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 24, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Study Protocol, Randomized Clinical Trial

Locations