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Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. (BedRest-1)

2026년 6월 17일 업데이트: Hospital Clinic of Barcelona

Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women

This study aims to evaluate the impact of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. This is a specifically designed physical activiity program, consisting of a resistance and strength exercises intended to be performed even while in bed and seeks to address physical and emotional health challenges during hospitalization. The study will compare outcomes between participants who follow the exercise program and those receiving standard care. Primary outcomes include physical and emotional health parameters, quality of life, and sleep quality. Secondary outcomes focus on feasibility, adherence, and participant satisfaction. This research addresses the gap in physical activity guidelines for pregnant individuals on bed rest and explores the potential benefits of exercise to improve maternal well-being and postpartum recovery.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

This study investigates the feasibility and potential benefits of a specifically designed exercise program for hospitalized high-risk pregnant individuals on bed rest. The program includes resistance and strength exercises tailored to be safely performed while in bed, aiming to counteract the physiological and psychological deconditioning associated with prolonged inactivity during hospitalization.

Prolonged bed rest during pregnancy, often prescribed for high-risk conditions, can result in muscle atrophy, reduced cardiovascular capacity, and psychological distress, including anxiety, stress, and depression. Despite the known adverse effects of inactivity, there is limited evidence on structured exercise programs for this population. This study seeks to fill that gap by testing an intervention designed to mitigate these negative outcomes.

Participants will be randomized into two groups: an exercise group (EG) and a no-exercise group (NEG). The EG will perform daily supervised exercises, lasting approximately 30 minutes, under the guidance of trained staff. The NEG will follow standard care without structured physical activity. The study evaluates physical health parameters (e.g., activity levels, muscle strength), mental health outcomes (e.g., anxiety, depression, stress), sleep quality, and quality of life. Secondary objectives include assessing program feasibility, recruitment rates, adherence, and participant satisfaction.

Data collection will include validated self-reported questionnaires, wearable devices (accelerometers), and clinical measures. Key endpoints will be compared between groups at regular intervals during hospitalization and at six weeks postpartum.

This pilot randomized controlled trial aims to generate knowledge on the acceptability, safety, and preliminary effectiveness of bed-rest exercise programs in high-risk pregnancies, with the goal of informing future larger-scale studies and addressing an unmet need in maternal care.

연구 유형

중재적

등록 (추정된)

140

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Montse Palacio, MD, PhD
  • 전화번호: 9946 +34932275400
  • 이메일: secmmf@clinic.cat

연구 연락처 백업

  • 이름: Federico Migliorelli, Migliorelli, MD, PhD
  • 전화번호: 9946 +34932275400
  • 이메일: secmmf@clinic.cat

연구 장소

  • 스페인
    • Barcelona
      • Barcelona, Barcelona, 스페인, 08028
        • Hospital Clínic de Barcelona
        • 연락하다:
          • Montse Palacio, MD, PhD
          • 전화번호: 9946 +34932275400
          • 이메일: secmmf@clinic.cat
        • 연락하다:
          • Federico Migliorelli, MD, PhD
          • 전화번호: 9946 +34932275400
          • 이메일: secmmf@clinic.cat

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Maternal age of 18 or more
  • Delivery not expected within 1 week after recruitment.
  • Language ability to understand the study.
  • Informed consent signed.

Exclusion Criteria:

  • Fetal death
  • Severe mental health disorders and substance abuse disorders.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication and will receiving the intervention and monitored according to study procedures
다른: 운동
특별히 설계되고 구조화된 운동 프로그램(저항/근력을 기반으로 하며 침대에서 또는 최소한의 이동성을 갖도록 설계됨). 이는 Brun CR 등(Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola MF)이 설명한 운동 프로그램을 각색한 것입니다. 침상 안정 운동, 활동 제한 및 고위험 임신: 타당성 조사. 응용 생리학, 영양 및 대사. 2011;36(4):577-582).
간섭 없음: Non-exercise group
Pregnant women admitted in the Maternal Intermediate Care Unit who will follow the standard management for its complication without any specific instructions to engage in physical activity, also monitored according to study procedures.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
운동 프로그램 시행의 타당성 평가: 표본 규모 모집에 필요한 시간
기간: 연구 완료를 통해 평균 6개월
표본 크기를 모집하는 데 필요한 시간(일)
연구 완료를 통해 평균 6개월
운동 프로그램 시행의 타당성 평가 : 연구 참여를 거부한 여성의 수
기간: 연구 완료를 통해 평균 6개월
연구 참여를 거부한 여성의 수
연구 완료를 통해 평균 6개월
운동 프로그램 시행의 타당성 평가 : 연구 참여를 포기한 여성의 수
기간: 연구 완료를 통해 평균 6개월
연구 참여를 포기한 여성의 수
연구 완료를 통해 평균 6개월
훈련 프로그램 시행의 타당성 평가 : 프로그램 준수 여부
기간: 연구 완료를 통해 평균 6개월
프로그램 준수 여부(입원 기간 동안 운동 프로그램을 실제로 수행한 일수)
연구 완료를 통해 평균 6개월
만족도 평가
기간: 배송 시
다양한 영역(세션 기간, 세션의 강도, 세션의 일일 반복, 특정 운동의 어려움, 재입원 시 반복 의향, 프로그램에 포함될 전반적인 만족도)을 평가하는 사례를 위해 특별히 작성된 설문지 ) - 리커트 척도(1~5, 1은 전혀 만족하지 않음, 5는 매우 만족함).
배송 시
Physiological parameters: Rectus femoris area measurement
기간: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Loss of rectus femoris area (cm2) in a relaxed state, assessed by ultrasound
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Time spent in moderate or vigorous activity
기간: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Time spent in moderate or vigorous activity (in minutes, summarized as average per day).
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Total physical activity
기간: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Total physical activity (average per day in mG).
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Physiological parameters: Handgrip strength test.
기간: Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Handgrip strength test (in kg, adjusted for gender and age).
Baseline, weeks 1, 2, 3, 4, 5 to 6 after enrolment, within 24h after delivery and 6 weeks postpartum
Mental health/emotional parameters: GAD-7
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
GAD-7: Generalized Anxiety Disorder assessment scale (score ranging from 0 to 21). The higher the results, higher is the severity of anxiety.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Mental health/emotional parameters: Perceived Stress Scale (PSS-10)
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Perceived Stress Scale (PSS-10) (score ranging from 0 to 40). The higher the results, higher is the perception of stress.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Mental health/emotional parameters: Edinburg Postpartum Depression Scale
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Edinburg Postpartum Depression Scale (EPDS) (score -ranging from 0 to 30- and percentage of score ≥9). The higher the total score, more intense is the emotional stress.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Sleep cycle and Quality of life parameters: Sleep average per night
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
Sleep average per night (in minutes)
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
Sleep cycle and Quality of life parameters: WHOQOL-BREF score
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
Abbreviated version of the World Health Organization Quality of Life Assessment scale (WHOQOL-BREF) (score ranging from 0 to 100). The higher the score, better is the perception of quality of life.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery
Mental health/emotional parameters: SAM: The Self-Assessment Manikin
기간: Daily
Visual standardized measure of emotional tone that covers 3 different affective domains (valence, arousal and sense of control). Responses are made by selecting the manikin that best represents the emotional state of the patient. The patient selection is afterwards converted into a numerical result with higher scores indicating more positive affective tone.
Daily
Mental health/emotional parameters: RRS: The Ruminative Response Scale
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
10-item questionnaire intended to measure rumination, tendency to worriedness and repetitive thinking in front of stressful situations. (score ranking from 10 to 40). Higher scores indicate a higher tendeny to ruminate and a vulnerability trait to psychological distress
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Mental health/emotional parameters: BDI-II:
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Questionnaire to measuring depression at a cognitive, affective and behavioral level. For the present study only 4 items related to hedonic experience will be selected. Higher scores in each item indicate severity in the loss of hedonic capacity. Reponses are made by using a 4-point Likert scale.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Physiological parameters: Muscle Ultrasound
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Muscle ultrasound will be conducted weekly by blinded sonographers using a linear probe (7.5 - 10 MHz). All images will be acquired in triplicate, and the average value will be used for analysis.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Physiological parameters: Maternal Cardiac Ultrasound
기간: Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Transthoracic echocardiography will be performed using standardised imaging protocols. All measurements will be performed in triplicate when feasible, and averaged for analysis. Standardization of acquisition settings and operator blinding to clinical data will be ensured to reduce measurement bias.
Baseline, 2, 4 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum

2차 결과 측정

결과 측정
측정값 설명
기간
Baseline Maternal and fetal characteristics: Evaluation of physical activity (GAQ-P questionnaire)
기간: Baseline
The questionnarie self-clasisfies how often and for how long the participant engages in light-, moderate-, or vigorous-intensity physical activity. It also assesses whether the participant should consult her obstetric health care provider before beginning or continuing physical activity during pregnancy. The GAQP is a screening and classification tool and does not generate a numerical summary score. Therefore, no minimun or maximum applies, and higher or lower scores do not indicate a better or worse outcome.
Baseline
Baseline Maternal and fetal characteristics: Maternal age
기간: Baseline
Maternal age (In years)
Baseline
Baseline Maternal and fetal characteristics: Maternal weight
기간: Baseline
Maternal weight (In kg)
Baseline
Baseline Maternal and fetal characteristics: Ethnic group
기간: Baseline
Ethnic group classified as: - White/European - Hispanic/latin American - Black/African Americans - Arabic - Asian
Baseline
Baseline Maternal and fetal characteristics: Gestational age at recruitment
기간: Baseline
Gestational age at recruitment (in weeks + days)
Baseline
Baseline Maternal and fetal characteristics: Twin pregnancy
기간: Baseline
Twin pregnancy (yes/no)
Baseline
Baseline Maternal and fetal characteristics: Fetal growth percentile at admission
기간: Baseline
Fetal growth percentile at admission (customized for gender and multiplicity)
Baseline
Baseline Maternal and fetal characteristics: Medical condition that justifies hospital admission
기간: Baseline
Medical condition that justifies hospital admission (hypertensive disorders, preterm labor, rupture of membranes, antepartum bleeding, others)
Baseline
Baseline Maternal and fetal characteristics: Musculoskeletal limitations
기간: Baseline
Musculoskeletal limitations (injuries or pathologies) (yes/no and description)
Baseline
Maternal and fetal characteristics during hospital admission: Medication while admitted
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Medication while admitted (antihypertensive treatment, tocolysis, magnesium sulphate, antibiotics, corticosteroids, others)
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Length of stay in the intermediate care unit
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Length of stay in the intermediate care unit (in days)
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Length of hospital admission
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Length of hospital admission (in days)
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Fetal CTG
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Fetal CTG description
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Diet during the admission
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Diet during the admission (in Kcal and special needs)
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Maternal and fetal characteristics during hospital admission: Daily fluid intake
기간: Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Daily fluid intake (in mL)
Baseline, 1, 2, 3, 4, 5 and 6 weeks after enrolment, whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Gestational age at delivery
기간: Whitin 24h after delivery and 6 weeks postpartum
Gestational age at delivery (in weeks + days
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Birthweight
기간: Whitin 24h after delivery and 6 weeks postpartum
Birthweight (in grams) and percentile
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: SGA/growth restriction
기간: Whitin 24h after delivery and 6 weeks postpartum
SGA/growth restriction (yes/no) and classification, if any
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Mode of delivery
기간: Whitin 24h after delivery and 6 weeks postpartum
Mode of delivery (spontaneous, assisted, cesarean section)
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Composite adverse maternal outcome
기간: Whitin 24h after delivery and 6 weeks postpartum
Composite adverse maternal outcome (yes/no considering any of the following: re-intervention, endometritis, infection of surgical wound, curettage, admission to intensive care unit, hysterectomy, need for transfusion, postpartum hemorrhage requiring medication other than oxytocin or ergometrine, maternal sepsis, death)
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Neonatal admission to neonatal intensive care unit
기간: Whitin 24h after delivery and 6 weeks postpartum
Neonatal admission to neonatal intensive care unit (yes/no)
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Composite adverse neonatal outcome
기간: Whitin 24h after delivery and 6 weeks postpartum
Composite adverse neonatal outcome: (yes/no considering any of the following: respiratory morbidity - respiratory distress syndrome or transient tachypnea - requiring intubation, moderate-severe bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV, early-onset sepsis, periventricular leukomalacia, necrotizing enterocolitis, retinopathy requiring laser, fetal or neonatal death)
Whitin 24h after delivery and 6 weeks postpartum
Perinatal outcomes: Breastfeeding rates
기간: Whitin 24h after delivery and 6 weeks postpartum
Breastfeeding rates
Whitin 24h after delivery and 6 weeks postpartum

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hospital Clinic of Barcelona

수사관

  • 수석 연구원: Federico Migliorelli, MD, PhD, Gynecologist especialist on Maternal fetal medicine

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2029년 9월 1일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 17일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BedRest Pregnancy Study

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data (IPD) will not be shared with esteranl researchers. Study finding will be reported in peer-reviewed scientific journals and presented at scientific meetings in aggregate form, without disclosure of identifiable participant information.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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건강 상태

약물 개입

CROs by country

CROs in Saint Lucia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다