Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

IMPORTANCE: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER: Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design.

Importance: Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER- Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. Methods: RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. Discussion: RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. Registration: NCT05172024.

Restorative yoga in adults with metabolic syndrome: a randomized, controlled pilot trial.

BACKGROUND: Metabolic syndrome increases the risk of diabetes and cardiovascular disease. Yoga improves some metabolic parameters, but it has not been studied in persons with metabolic syndrome. We conducted a randomized controlled pilot trial to determine whether a restorative yoga intervention was feasible and acceptable in underactive, overweight adults with metabolic syndrome. METHODS: Twenty six underactive, overweight adult men and women with metabolic syndrome were randomized to attend 15 yoga sessions of 90 minutes each over 10 weeks or to a wait-list control group. Feasibility was measured by recruitment rates, subject retention, and adherence. Acceptability was assessed by interview and questionnaires. Changes in metabolic outcomes and questionnaire measures from baseline to week 10 were calculated. RESULTS: A total of 280 people were screened by phone, and 93 with high likelihood of metabolic syndrome were invited to a screening visit. Of the 68 who attended screening visits, 26 (38%) were randomized, and 24 (92%) completed the trial. Attendance at yoga classes and adherence to home practice exceeded our goals. In the yoga group, all participants gave the study the highest possible satisfaction rating, and the majority (87%) felt that the yoga poses were easy to perform. There was trend to reduced blood pressure (p = 0.07), a significant increase in energy level (p < 0.009), and trends to improvement in well-being (p < 0.12) and stress (p < 0.22) in the yoga versus control group. CONCLUSIONS: Restorative yoga was a feasible and acceptable intervention in overweight adults with metabolic syndrome. The efficacy of yoga for improving metabolic parameters in this population should be explored in a larger randomized controlled trial.

Feasibility and acceptability of restorative yoga for treatment of hot flushes: a pilot trial.

OBJECTIVE: To determine the feasibility and acceptability of a restorative yoga intervention for the treatment of hot flushes in postmenopausal women. METHODS: A pilot trial in 14 postmenopausal women experiencing > or =4 moderate to severe hot flushes per day or > or =30 moderate to severe hot flushes per week. The intervention consisted of eight restorative yoga poses taught in a 3-h introductory session and 8 weekly 90-min sessions. Feasibility was measured by recruitment rates, subject retention and adherence. Acceptability was assessed by subject interview and questionnaires. Efficacy measures included change in frequency and severity of hot flushes as recorded on a 7-day diary. RESULTS: Recruitment was accomplished as planned. The majority of study subjects (93%) completed the trial. Of those who completed the trial, 92% attended seven or more of the eight yoga sessions. The majority of the subjects were satisfied with the study and 75% continued to practice yoga 3 months after the study. Mean number of hot flushes per week decreased by 30.8% (95% CI 15.6-45.9%) and mean hot flush score decreased 34.2% (95% CI 16.0-52.5%) from baseline to week 8. No adverse events were observed. CONCLUSIONS: This pilot trial demonstrates that it is feasible to teach restorative yoga to middle-aged women without prior yoga experience. The high rates of subject retention and satisfaction suggest that yoga is an acceptable intervention in this population. Our results indicate that a larger, randomized controlled trial to explore the efficacy of restorative yoga for treatment of menopausal symptoms would be safe and feasible.