Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Anxiety
时间窗: change anxiety at 8 weeks and follow-up at 12 weeks
Beck Anxiety Inventory (better 0-63 worse points)
Depression
时间窗: change depression at 8 weeks and follow-up at 12 weeks
Beck Depression Inventory (better 0-63 worse points)
次要结局
- Cognitive(change cognitive at 8 weeks and follow-up at 12 weeks)
- Stress(change stress at 8 weeks and follow-up at 12 weeks)
- Functionally(change functionally at 8 weeks and follow-up at 12 weeks)
- Sleep Quality(change sleep quality 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)
- Life Style Scale(change life style at 8 weeks and follow-up at 12 weeks)
研究者
Rodrigo Gustavo da Silva Carvalho
Principal Investigator
Universidade Federal do vale do São Francisco
