Efecto de Caminar en La prevención de aparición de Insomnio en el Tercer Trimestre de la gestación. Ensayo de Campo Controlado y Aleatorizado
试验速览
- 阶段
- 不适用
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale
研究概览
简要总结
Randomized Control Trial (RCT), were healthy but sedentary women are selected in their first trimester of pregnancy. This RCT has two interventions arms (pedometer plus a goal of 11,000 steps / day and pedometer without goal) and a control group arm, without the use of pedometer. The main objective is to promote physical activity in pregnancy decreasing the prevalence of insomina at their third trimester of pregnancy.
详细描述
General Objective: To determine the effect of a walking program during pregnancy in the prevention of the appearance of insomnia in the third trimester of pregnancy, in the increase of the quality of sleep and in the improvement of the quality of life throughout pregnancy.
Specific Objectives: Comparison of the interventions group versus the control group; at the beginning, middle and end of the program of the following indicators: 1. Average steps/day; 2. Frequency of insomnia; 3. Hours of night sleep and quality of sleep; 4. Quality of life level.
Methodology: Randomized Control trial in parallel in healthy sedentary pregnant women belonging to the Virgen de las Nieves Hospital in Granada, Spain. At 12 weeks of gestation (GW) they will be invited to participate and randomly assigned to the intervention group I2 (pedometer, with goal of 11,000 steps / day), intervention group I1 (pedometer without goal) and control (without pedometer). Duration of the intervention: 13-32 GW. At 12, 19 and 31GW the average steps/day will be measured in groups I2 and I1. In weeks 13, 20 and 32GW, the following variables will be collected: the Athens Insomnia Scale, the Sleep Quality Index (Pittsburgh), adherence to the Mediterranean Diet (Predimed), physical activity (short IPAQ), quality of life (PSI), the consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco), the anthropometric variables of pregnant woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants know they will be selected for either a pedometer group or a not pedometer group. They wil not know if the intervention is minimum (pedometer only) or maximum (pedometer and a goal of 11000 steps/day)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Low risk pregnancies that are attending in the Unit of Obstetrics and Gynecology of the Hospital Materno-Infantil de Granada.
- •Sedentary women (<5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to <7.000 steps/day).
- •With mobile phone and e-mail
- •Without intellectual deficits or difficulty to understand the language.
排除标准
- •Chronic disease: diabetes, high pressure, cardiac or respiratory disease, liver or kidney disease or mobility problems.
- •Women with relative or absolute repose.
- •Active women (>5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to >7.000 steps/day).
- •Insomnia at beginning of pregnancy or having drugs for sleep problems.
研究组 & 干预措施
Intervention 1: pedometer
Minimum intervention:
- Use of pedometer watch from 12 to 32 GW
- Recommendations of physical activity
干预措施: Pedometer watch 'Xiomi mi band2' (Device)
Intervention 2: pedometer+goal+reminds
Maximum intervention:
- Use of pedometer from 12 to 32 GW
- Recommendations of physical activity
- Information about get a goal of 11000 steps/day
- Reminds the goal every two weeks.
干预措施: Pedometer watch 'Xiomi mi band2' (Device)
Control: without pedometer
Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy
结局指标
主要结局
Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale
时间窗: 32 Gestational Week (GW)
Insomnia Athens Scale (IAS): An eight-item scale that assesses the quantity and quality of sleep (first five items) and the diurnal repercussion of insomnia (daytime sleepiness, physical and mental functioning and well-being during the day). Each of the items scores from 0 to 3 (affectation of the item from light to severe). The total score ranges from 0 to 24 points, considering insomnia from a score equal to or greater than 6 points (S = 93% and E = 85%) or equal to or greater than 7 points (S = 84% and E = 90%).
Change in mean steps/day after intervention in the arms using pedometer
时间窗: 19 Gestational Week (GW) and 32 GW
Pedometer register
次要结局
- Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire(12 (GW), 19 GW and 32 GW)
研究者
Carmen Amezcua Prieto
Principal Investigator
Universidad de Granada