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Walking Promotion in Pregnancy and Its Effects on Insomnia: Results of Walking_Preg Project (WPP) Clinical Trial.

ABSTRACT: Introduction: Insomnia is a frequent condition during pregnancy. The aim of this study was to assess if a walking promotion program from the 12th Gestational Week (GW) of pregnancy helps to prevent insomnia and improve the quality of sleep at third trimester. Materials and Methods: A prospective, randomized, and controlled trial was conducted with 270 pregnant women divided into 3 groups in parallel: maximum intervention group, I1 (pedometer and goal of 10,000 steps/day), minimum intervention group, I2 (pedometer without a goal), and control group (no intervention). All groups received recommendations about physical activity in pregnancy. A structured interview was performed at 13th, 20th, and 32nd GW, collecting pedometer mean steps/day, Athens Insomnia Scale (AIS), and Pittsburgh questionnaire (PSQI). Lineal regression models were conducted to determine the association between mean steps/day at 31st GW and AIS or PSQI score. Results: At 19th GW, groups I1 and I2 reached a mean of 6267 steps/day (SD = 3854) and 5835 steps/day (SD = 2741), respectively (p > 0.05). At 31st GW mean steps/day was lower for I2 (p < 0.001). Insomnia and poor sleep quality prevalence increased through pregnancy, but no differences between groups, within trimesters, were found (p > 0.05). Lineal regression showed no association between the average steps/day at third trimester of pregnancy and AIS and PSQI scores. Conclusions: Our walking promotion program based on pedometers did not help to prevent insomnia in the third trimester of pregnancy.

SUBMITTER: Benito-Villena R

PROVIDER: S-EPMC9408512 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Walking Promotion in Pregnancy and Its Effects on Insomnia: Results of Walking_Preg Project (WPP) Clinical Trial.

Benito-Villena Rebeca R Guerrero-Martínez Ingrid I Naveiro-Fuentes Mariña M Cano-Ibánez Naomi N Femia-Marzo Pedro P Gallo-Vallejo José Luis JL Mozas-Moreno Juan J Amezcua-Prieto Carmen C

International journal of environmental research and public health 20220813 16

Introduction: Insomnia is a frequent condition during pregnancy. The aim of this study was to assess if a walking promotion program from the 12th Gestational Week (GW) of pregnancy helps to prevent insomnia and improve the quality of sleep at third trimester. Materials and Methods: A prospective, randomized, and controlled trial was conducted with 270 pregnant women divided into 3 groups in parallel: maximum intervention group, I1 (pedometer and goal of 10,000 steps/day), minimum intervention gr ...[more]

PMID: 36011647

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Project description:BackgroundPrevious studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy.MethodsRandomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13-32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson's Chi-square test or Fisher's exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software.Discussionpromoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved -'10,000-11,000 steps a day'- should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women.Trial registrationClinicalTrials.gov Identifier: NCT03735381 . Registered 8th November, 2018.

Project description:Conventional dissemination of clinical trial results has inconsistent impact on physician practices. A more comprehensive plan to influence determinants of prescribing practices is warranted.To report the response from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial to the National Heart, Lung, and Blood Institute's requirement for dissemination and evaluation of trials with potential immediate public health applicability.ALLHAT's dissemination plan had two-components: (1) a traditional approach of media coverage, scientific presentation, and publication; and (2) a theory-based approach targeting determinants of clinician behavior. Strategies included: (1) academic detailing, in which physicians approach colleagues regarding blood pressure management, (2) direct patient messages to stimulate communication with physicians regarding blood pressure control, (3) approaches to formulary systems to use educational and economic incentives for evidence-based prescription, and (4) direct professional organization appeals to clinicians.One hundred and forty-seven Investigator Educators reported 1698 presentations to 18,524 clinicians in 41 states and the District of Columbia. The pre- and post-test responses of 1709 clinicians in the face-to-face meetings indicated significant changes in expectations for positive patient outcomes and intention to prescribe diuretics. Information was mailed to 55 individuals representing 20 professional organizations and to eight formulary systems. Direct-to-patient messages were provided to 14 sites that host patient newsletters and Web sites such as health plans and insurance companies, 62 print mass media outlets, and 12 broadcast media sites.It was not within the scope of the project to conduct a randomized trial of the impact of the dissemination. However, impact evaluation using quasi-experimental designs is ongoing.A large multi-method dissemination of clinical trial results is feasible. Planning for dissemination efforts, including evaluation research, should be considered as a part of the funding and design of the clinical trial and should begin early in trial planning.

Project description:Background: Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions. Methods: A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons. Results: A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively. Conclusions: It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.

Dataset Information

Walking Promotion in Pregnancy and Its Effects on Insomnia: Results of Walking_Preg Project (WPP) Clinical Trial.

Publications

Walking Promotion in Pregnancy and Its Effects on Insomnia: Results of Walking_Preg Project (WPP) Clinical Trial.

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