Trial Outcomes & Findings for Physical Activity in Pregnancy and Postpartum Period, Effects on Women (NCT NCT02761967)
NCT ID: NCT02761967
Last Updated: 2019-10-10
Results Overview
This result is to measure the difference in time between births to women who have made physical exercise during pregnancy, SWEP method, compared to women who have not exercised .
COMPLETED
NA
140 participants
Twenty four month
2019-10-10
Participant Flow
Participant milestones
| Measure |
Physical Activity
1. º Phase: Swep Method. Warm up: The warm-up exercise will take place in a small vessel, where the water depth is around the thighs.
Central part of the activity: It is be held in the large vessel, exercise intensity will increase in order to keep within the limits for an exercise of moderate, use different devices support to carry it out and exercises of strength, endurance and pelvic elasticity are included.
Phase cool down: In this phase the participants will seek to return to calm, will be done in the small vessel having 3-4 ° C more than the large glass. exercises to progressively reducing the intensity and ending with relaxation exercises will be conducted .
2. º Phase: Low Pressure Fitness. Concluded the postpartum period. Women begin a program of recovery postpartum 12 weeks, 3 times a week in sessions of one hour. They perform warm-up exercises, a central part of Low Pressure Fitness exercises and end with stretching exercises.
|
No Exercise
Not take place during the gestation period between gestation week 20 to 37 any physical exercise.
Not take place during the postpartum period any physical exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
65
|
64
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physical Activity
n=70 Participants
The woman he joins the intervention group meets once a week 20 of gestation and ends after serving 37 weeks. Intervention will consist of physical exercise of moderate character in water, according to the methodology of the method of SWEP, for an hour a day, three days a week.
After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
Physical activity: Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
|
No Exercise
n=70 Participants
Not take place during the gestation period between gestation week 20 to 37 any physical exercise.
Not take place during the postpartum period any physical exercise.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=70 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=70 Participants
|
70 Participants
n=70 Participants
|
140 Participants
n=140 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=70 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
|
Age, Continuous
|
34.74 years
STANDARD_DEVIATION 4.41 • n=70 Participants
|
33.47 years
STANDARD_DEVIATION 5.18 • n=70 Participants
|
34.1 years
STANDARD_DEVIATION 4.7 • n=140 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=70 Participants
|
70 Participants
n=70 Participants
|
140 Participants
n=140 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=70 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
70 Participants
n=70 Participants
|
70 Participants
n=70 Participants
|
140 Participants
n=140 Participants
|
|
BMI
|
24.7 kg/m^2
STANDARD_DEVIATION 4.16 • n=70 Participants
|
24.93 kg/m^2
STANDARD_DEVIATION 4.80 • n=70 Participants
|
24.81 kg/m^2
STANDARD_DEVIATION 4.4 • n=140 Participants
|
PRIMARY outcome
Timeframe: Twenty four monthPopulation: The total duration of delivery times between women in the control group and women in the exercise group will be compared.
This result is to measure the difference in time between births to women who have made physical exercise during pregnancy, SWEP method, compared to women who have not exercised .
Outcome measures
| Measure |
Physical Activity
n=60 Participants
The women in the EG performed moderate physical exercise in water, following the SWEP method (Study of Water-based Exercise during Pregnancy). It consists of performing moderate physical exercise in an aquatic environment from weeks 20 to 37 of gestation. The sessions take place three times weekly, with a duration of 60 minutes each (45 minutes of activity followed by 15 minutes of relaxation). The sessions are composed of three phases: a) warm-up; b) the main phase, divided into aerobic exercise and strength-endurance exercises, designed specifically for pregnant women; c) stretching and relaxation.
After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
|
No Exercise
n=60 Participants
The CG received the standard recommendations during pregnancy, including guidelines from the midwife on the positive effects of physical exercise. These participants received the usual visits from healthcare providers (midwives, obstetricians and family doctor) during pregnancy, as did those in the EG.
After the postpartum period, the women in the control group did not perform regulated physical activity.
|
|---|---|---|
|
Delivery Times Measured in Partogram
|
389.33 minutes
Standard Deviation 216.18
|
561.3 minutes
Standard Deviation 199.94
|
PRIMARY outcome
Timeframe: Six monthDetermine the rate of postpartum depression in both groups. The scale consists of ten short questions, all of which must be answered. The subject is asked to choose, of the four possible answers, the one that most closely describes how she felt during the week prior to the test. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score is recorded in a table ranging from 0 to 30, where higher values indicate more severe symptoms of depression. For this study, total scores below 10 were classed as "no risk" and scores of 10 or more indicated the presence of risk. Scores above 16 indicated a more severe risk of depression, and suggested that additional evaluations should be conducted immediately.
Outcome measures
| Measure |
Physical Activity
n=70 Participants
The women in the EG performed moderate physical exercise in water, following the SWEP method (Study of Water-based Exercise during Pregnancy). It consists of performing moderate physical exercise in an aquatic environment from weeks 20 to 37 of gestation. The sessions take place three times weekly, with a duration of 60 minutes each (45 minutes of activity followed by 15 minutes of relaxation). The sessions are composed of three phases: a) warm-up; b) the main phase, divided into aerobic exercise and strength-endurance exercises, designed specifically for pregnant women; c) stretching and relaxation.
After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
|
No Exercise
n=70 Participants
The CG received the standard recommendations during pregnancy, including guidelines from the midwife on the positive effects of physical exercise. These participants received the usual visits from healthcare providers (midwives, obstetricians and family doctor) during pregnancy, as did those in the EG.
After the postpartum period, the women in the control group did not perform regulated physical activity.
|
|---|---|---|
|
Edinburgh Postnatal Depression Scale
|
6 units on a scale
Standard Deviation 3.39
|
8 units on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Twelve monthPopulation: During the data collection, 3 women from the control group were lost because they did not complete the PSQI questionnaire during the follow-up phase. The analysis excluded 3 women from the intervention group due to errors at the time of completing the PSQI questionnaire.
Assess the quality of sleep of pregnant women with moderate activity in water, with respect to who do not practice. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Physical Activity
n=67 Participants
The women in the EG performed moderate physical exercise in water, following the SWEP method (Study of Water-based Exercise during Pregnancy). It consists of performing moderate physical exercise in an aquatic environment from weeks 20 to 37 of gestation. The sessions take place three times weekly, with a duration of 60 minutes each (45 minutes of activity followed by 15 minutes of relaxation). The sessions are composed of three phases: a) warm-up; b) the main phase, divided into aerobic exercise and strength-endurance exercises, designed specifically for pregnant women; c) stretching and relaxation.
After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
|
No Exercise
n=67 Participants
The CG received the standard recommendations during pregnancy, including guidelines from the midwife on the positive effects of physical exercise. These participants received the usual visits from healthcare providers (midwives, obstetricians and family doctor) during pregnancy, as did those in the EG.
After the postpartum period, the women in the control group did not perform regulated physical activity.
|
|---|---|---|
|
Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)
|
6.84 units on a scale
Standard Deviation 2.86
|
10.10 units on a scale
Standard Deviation 3.12
|
Adverse Events
Physical Activity
No Exercise
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place