Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women. A Pilot Study
Phase: NA
Conditions: Bed Rest, Pregnancy, Pregnancy Complications
Sponsor: Montse Palacio

 
 
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1 
General Information 
1.1 
Study identification 
Title: 
Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.  
Codi o número d’identificació del protocol: Bed RestPregnancy 
Versió i data: v02, 31/07/2024 
1.2 
Promoter  
Montse Palacio. Senior Consultant in Maternal-Fetal Medicine, Hospital Clínic Barcelona 
(BCNatal Fetal Medicine Research Center), Universitat de Barcelona. 
 
1.3 Principal investigators of our own center 
Montse Palacio, Senior Consultant in Maternal-Fetal Medicine. Servei de Medicina 
Maternofetal. Institut Clínic de Ginecologia, Obstetrícia i Neonatologia. Hospital Clínic 
Barcelona (BCNatal Fetal Medicine Research Center), Universitat de Barcelona, 
Barcelona, Spain. 
Phone: +34 2279946. Sabino de Arana, 1. 08028 Barcelona. 
 
1.4 
Principal Investigators of the participant centers 
Eva Ferrer Vidal-Barraquer, Specialist in Sports Medicine, Unitat de Medicina de l’ 
Esport Hospital Sant Joan de Déu – Hospital Clínic, Universitat de Barcelona. , Barcelona, 
Spain. 
Phone: +34 2532100. Passeig Sant Joan de Deu 2. 08950 Esplugues del Llobregat (BCN) 
 
Rubén Barakat, Full Professor in the Faculty of Physical Activity and Sports Sciences 
(Facultad de Ciencias de la Actividad Fısica y el Deporte). Director of the Physical 
Activity and Sports in Specific Populations (AFIPE) Research Group. Universidad 
Politécnica de Madrid, Madrid, Spain. 
 
1.5 
Collaborating Investigators of the participating centers. 
Francesc Figueras, Senior Consultant in Maternal-Fetal Medicine. Servei de Medicina 
Maternofetal. Institut Clínic de Ginecologia, Obstetrícia i Neonatologia. Hospital Clínic 
Barcelona (BCNatal Fetal Medicine Research Center), Universitat de Barcelona, 
Barcelona, Spain. 
Phone: +34 2279946. Sabino de Arana, 1. 08028 Barcelona. 
 
Federico Migliorelli, Senior Specialist in Maternal-Fetal Medicine. Servei de Medicina 
Maternofetal. Institut Clínic de Ginecologia, Obstetrícia i Neonatologia. Hospital Clínic 
Barcelona (BCNatal Fetal Medicine Research Center), Universitat de Barcelona, 
Barcelona, Spain. 
Phone: +34 2279946. Sabino de Arana, 1. 08028 Barcelona. 
 
Andrea Javierre, Midwife, predoctoral researcher. Servei de Medicina Maternofetal. 
Institut Clínic de Ginecología, Obstetrícia i Neonatologia. Hospital Clínic Barcelona 

 
 
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(BCNatal Fetal Medicine Research Center), Universitat de Barcelona, Barcelona, Spain. 
Elena González, Senior Midwife. Servei de Medicina Maternofetal. Institut Clínic de 
Ginecología, Obstetrícia i Neonatologia. Hospital Clínic Barcelona (BCNatal Fetal 
Medicine Research Center), Universitat de Barcelona, Barcelona, Spain. 
Sandra Escolà, Physiotherapist, predoctoral researcher in Sports Medicine, Hospital 
Sant Joan de Déu (BCNatal Fetal Medicine Research Center), Universitat de Barcelona, 
Barcelona, Spain. 
Aida Mallorquí, Clinical Psychologist. Secció de Psicologia Clínica. Institut Clínic de 
Neurociències. Hospital Clínic Barcelona, Universitat de Barcelona, Barcelona, Spain. 
Xavier Segú, Clinical Psychologist. Secció de Psicologia Clínica de la Salut. Institut Clínic 
de neurociències. Hospital Clínic Barcelona, Universitat de Barcelona, Barcelona, Spain. 
Gil Rodas, Consultant in Sports Medicine, Unitat de Medicina de l’ Esport, Hospital Clínic 
Barcelona – Hospital Sant Joan de Déu, Universitat de Barcelona., Barcelona, Spain. 

 
 
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2 
State of the Art 
Physical activity during pregnancy is safe and is associated with a variety of health 
benefits for mother and baby/fetus1: The results of systematic reviews identified that, compared 
with no physical activity (PA), accumulating at least 150 min of moderate-to-vigorous intensity 
PA over three or more days per week was associated with clinically meaningful reductions in the 
odds of developing gestational diabetes mellitus, pre-eclampsia, and gestational hypertension2 
and improves mental health and quality of life34. Despite the known health benefits of PA, yet 
few women engage in sufficient activity during pregnancy and so far, pregnancy is a time of 
marked decline in PA levels5. To provide women with reliable and trustworthy information, and 
to encourage greater participation in PA during pregnancy, many governments have developed 
guidelines for PA during pregnancy6. However, the actual fulfillment of these recommendations 
seems to be low7,8.    
While this is true for pregnancy overall, PA is indeed dramatically restricted when high-
risk pregnancy conditions may warrant bed rest or hospitalization. Overall, guidelines indicate 
absolute or relative contraindications to perform mean-to-vigorous PA in pregnancy 
complications although individuals should continue their usual activities of daily living1. Despite 
of these recommendations, individuals who develop complications during pregnancy have 
traditionally been prescribed activity restriction (the most severe form being complete bed rest) 
which could lead to a true sedentary lifestyle. So much so that despite the lack of evidence of 
the benefits of the activity restriction, it has been reported that up to 87% of North American 
clinicians would still prescribe bed rest for high-risk pregnant individuals for lack of better 
therapeutic options9. Indeed, women do tend to be 100% compliant with these 
recommendations leading to one third of pregnant women being restricted in her daily activity 
at some point during pregnancy5,10. Although some efforts have been given to counteract this 
sedentarism, the level of the recommendations to exercise are heterogeneous in terms of 
quantity and intensity depending also on physicians’ beliefs. 
Impact of severe restriction of PA as the one due to micro-gravity in astronauts has been 
studied11. Muscle loss may appear as soon as after 5-days in bed rest12 which makes a planned 
exercise program to counteract deconditioning mandatory. An extensive list of side-effects for 
every system have been described to occur due to the inactivity (fatigue, headache, mood 
changes, lower back pain, tenseness, difficulty concentrating, back muscle soreness, dry skin, 
cardiac atrophy, augmented heart rate, blood coagulation, heartburn and reflux, constipation, 
diminished lung compliance, decreased cardiac output and stroke volume, muscle atrophy, bone 
demineralization, joint contracture, thromboembolic disease, skin ulcers, glucose intolerance, 
skeletal muscle insulin resistance, and increased concentrations of blood cholesterol and 
triglycerides)11. Many of these side-effects appear in activity-restricted pregnant individuals who 
have been hospitalized due to a high-risk pregnancy, but this has not been fully studied13–15 as 
focus has been put on perinatal outcomes16–20 and not on physiological changes. Indeed, 
considering that also physical (hormonal, respiratory, cardiovascular, and skeletal) modifications 
and psychosocial (stress, anxiety, and depression) changes occur in normal pregnancy, pregnant 
individuals who are restricted in their daily activity or confined to bed rest due to complications, 
may potentially present even more deep alterations. Also, sleep duration and quality get worse21  
and depression, anxiety, stress, perception of loss of self-control and boredom increase22. 
Overall, the severity of these side-effects appears to be directly related to the degree of activity 
restriction23 . Therefore, all these changes may jeopardize their ability to resume an inevitable 
demanding activity in the postpartum period. 
On the other hand, there are studies that suggest exercise prescription may counteract 
deconditioning in non-pregnant females on bed rest. In this population, resistance exercise and 

 
 
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passive stretching of muscles may be a successful countermeasure to diminish cardiovascular 
deconditioning24,25 and bone deterioration accumulated during bed rest26–28. Therefore, 
although there are no studies to evaluate these improvements in pregnant individuals subjected 
to activity restriction, we could hypothesize that a dedicated combined resistance and strength 
exercise program could be proposed to prevent these changes to occur. Although some efforts 
are being made to overcome absolute restriction of the physical activity when medical 
complications appear during pregnancy29, only few data are available to design an adequate 
exercise routine30 which could potentially prevent from deconditioning during activity 
restriction and improve emotional experience for those women that need to be at bed rest in 
home or hospitalized. Indeed, considering that pre-habilitation programs have been proved to 
be of benefit to individuals which will be undergoing oncologic or major abdominal surgery,31–33 
an exercise program could potentially also be of benefit in those pregnant women in bed rest 
who will need to overcome in a near future the major changes that entails delivery and 
postpartum.  
In summary, benefits of physical activity in a normal pregnancy to prevent medical 
complications and mental health disorders have been proved. Therefore, benefits could be 
potentially higher if a specifically designed exercise program was performed by the group of 
pregnant women to who bed rest and/or hospitalization has been indicated. Indeed, 
maintaining a certain degree of fitness could potentially help to resume activity in the 
postpartum period when physical and emotional needs of the woman are increased. 
The experts on the topic acknowledge the lack of studies evaluating the effects of bed 
rest and different types of physical activity/exercise intervention on medical complications 
during pregnancy. Data suggest the importance of some type of activity over none and urge for 
future research.34,35  
More research is necessary to improve the health of those individuals who are 
hospitalized during pregnancy and urgent research is needed to evaluate the benefits of a 
specifically designed exercise program for women who have high-risk pregnancies and are 
severely activity restricted. Therefore, this is a knowledge-generating project aligned with the 
opportunity to reduce inequity and address this health issue from a gender perspective, given 
that the proposed topic fully impacts in women's health. 
A pilot RCT is necessary as a first step in order to evaluate acceptability and feasibility of 
the intervention and determine effect-size to assess future sample-size calculations to support 
the adequate design for an RCT.36 
 
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100056 
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Davenport MH, McCurdy AP, Mottola MF, et al. Impact of prenatal exercise on both prenatal 
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Hayman M, Brown WJ, Brinson A, Budzynski-Seymour E, Bruce T, Evenson KR. Public health 
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Gjestland K, Bø K, Owe KM, Eberhard-Gran M. Do pregnant women follow exercise guidelines? 
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Meander L, Lindqvist M, Mogren I, Sandlund J, West CE, Domellöf M. Physical activity and 
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McCall CA, Grimes DA, Lyerly AD. “Therapeutic” bed rest in pregnancy: unethical and 
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Bitar G, Sciscione A. The Compliance of Prescribed Activity Restriction in Women at High Risk for 
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Wall BT, Dirks ML, Snijders T, Senden JMG, Dolmans J, van Loon LJC. Substantial skeletal muscle 
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Lee SMC, Schneider SM, Feiveson AH, et al. WISE-2005: Countermeasures to prevent muscle 
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Promislow JHE, Hertz-Picciotto I, Schramm M, Watt-Morse M, Anderson JJB. Bed rest and other 
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Brandao KL, Mottola MF, Gratton R, Maloni J. Bone Status in Activity-Restricted Pregnant 
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Crowther CA, Han S. Hospitalisation and bed rest for multiple pregnancy. Cochrane Database of 
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Sosa CG, Althabe F, Belizán JM, Bergel E. Bed rest in singleton pregnancies for preventing 
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da Silva Lopes K, Takemoto Y, Ota E, Tanigaki S MR. Bed rest with and without hospitalization in 
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Lorenz RP. What is new in bed rest in pregnancy?: best articles from the past year. Obstetrics 
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Fox NS, Gelber SE, Kalish RB, Chasen ST. The recommendation for bed rest in the setting of 
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Spehar SM, Mission JF, Amanda Shupe, Facco FL. Prolonged antepartum hospitalization: no time 
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Finley PR, Brizendine L. Enhancing our understanding of perinatal depression. CNS Spectr. 
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Maloni JA, Seunghee Park Margevicius F, Elizabeth Damato RG. Multiple Gestation: Side Effects 
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Edgell H, Zuj KA, Greaves DK, et al. WISE-2005: adrenergic responses of women following 56-
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Brower RG. Consequences of bed rest. Crit Care Med. 2009;37(10 Suppl):S422-8. 
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3  
Hypothesis  
MAIN HYPOTHESIS 
 
The performance of a specifically designed exercise program (based on 
resistance/strength, designed to be executed while in bed) in a group of bed rest hospitalized 
pregnant individuals helps to improve its physical and emotional health and perception of health 
(including quality of life and sleep) during hospitalization compared to a control group in which 
a standard management (not including an structured exercise program) is carried out.  
 
Hypothesis 1 
Performing the specifically designed exercise program is associated with better 
maintenance of the physical condition after 1, 2 or 3 weeks of hospitalization before 
delivery and 6weeks postpartum, compared to a no-exercise group. 
 
Hypothesis 2 
Performing the specifically designed exercise program is associated with better 
maintenance of the mental/emotional condition after 1, 2 or 3 weeks of hospitalization 
before delivery and 6weeks postpartum, compared to a no-exercise group. 
 
Hypothesis 3 
Performing the specifically designed exercise program is associated with better 
perception of health, including quality of life and sleep, after 1, 2 or 3 weeks of 
hospitalization before delivery and 6weeks postpartum, compared to a no-exercise 
group. 
 
 
SECONDARY HYPOTHESIS 
 
The inclusion of a specifically designed exercise program (based on resistance/strength, 
designed to be executed while in bed) is well accepted, feasible and perceived as a good 
experience in a group of bed rest hospitalized pregnant individuals. 
 
Hypothesis 4 
The recruitment rate of a study of these characteristics is higher than 50% of the eligible 
women. 
 
Hypothesis 5 
Performing the specifically designed exercise program is feasible, with high adherence 
over the time and well tolerated by the pregnant individuals. 
 
Hypothesis 6 
Performing the specifically designed exercise program is perceived as a good experience 
contributing to the fetal/neonatal and maternal health. 
 
 

 
 
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4 
Objective of the study 
MAIN OBJECTIVE 
The main objective of this pilot study is to evaluate the impact of bed rest in terms of a) 
physiological parameters, b) mental health/emotional parameters and c) sleep cycle and quality 
of life parameters, in a group of bed rest hospitalized pregnant women. The parameters will 
then be compared depending on if they were included in a specifically designed exercise 
program (including resistance/strength exercises designed to be executed while in bed) or were 
followed by a standard management (not including an exercise program).  
 
SECONDARY OBJECTIVES  
To evaluate the recruitment rate in this type of study. 
To evaluate the feasibility and adherence to the specifically designed exercise program. 
To evaluate the satisfaction to be enrolled to the specifically designed exercise program. 
To evaluate some trait-level psychological variables that could be mediating the effects of 
adherence and satisfaction of the program.  
 
4.1 
Main variables 
 
• 
Exposure to the exercise program (yes/no) 
 
• 
Physiological parameters  
- Time spent in moderate or vigorous activity (average per day). 
- Total physical activity (average per day in mG).  
- Handgrip strength test (score adjusted for gender and age). 
- Calf Circumference measurement (cm adjusted for gender and age). 
 
• 
Mental health/emotional parameters 
- GAD-7 
- Perceived Stress Scale (PSS-10).  
- Edinburg Postpartum Depression Scale (EPDS) score and percentage of score ≥9. 
 
• Sleep cycle and Quality of life parameters 
- Sleep average per night. 
- Insomnia Severity Index (ISI) score and percentage of score ≥8. 
- WHOQOL-BREF score. 
 
• 
Feasibility evaluation of the implementation of the exercise program: time needed to 
recruit sample size, number of women who declined to participate in the study, number 
of women who give up participation in the study and adherence to the program (number 
of days of actual performance of the exercise program while admitted). 
 
• 
Satisfaction evaluation regarding the exercise program: a questionnaire made 
specifically for the case evaluating different domains (length of the sessions, hardness 
of the sessions, daily repetition of the sessions, difficulty in particular exercises, 
willingness to repeat in case of re-admission, overall satisfaction to be included in the 
program), will be run to each individual. 
 

 
 
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4.2 
Other variables 
 
• 
Baseline Maternal and fetal characteristics at recruitment: 
o Evaluation of physical activity (GAQ-P questionnaire) 
o Maternal age 
o Maternal weight 
o Ethnic group (White/European, Hispanic/latin American, Black/African 
Americans, Arabic, Asian) 
o Gestational age at recruitment (weeks.days) 
o Twin pregnancy (yes/no) 
o Fetal growth percentile at admission (customized for gender and multiplicity) 
o Medical condition that justifies hospital admission (hypertensive disorders, 
preterm labor, rupture of membranes, antepartum bleeding, others). 
o Musculoskeletal limitations (injuries or pathologies). 
 
• 
Maternal and fetal characteristics during hospital admission: 
o Medication while admitted (antihypertensive treatment, tocolysis, magnesium 
sulphate, antibiotics, corticosteroids, others) 
o Days in the intermediate care unit 
o Days of hospital admission 
o Fetal CTG (normal, suspicious, or pathological considering for gestational age 
and maternal medical condition). 
o Diet during the admission (Kcal, special needs) 
o Daily fluid intake 
o Other physiologic parameters: 
- Vitals: systolic and diastolic pressure, heart rate and temperature 
- Maternal weight 
- Percentage of time spent in inactivity, mild, moderate or vigorous activity 
and daily mean time (min) of activity. 
- Mean sleep period time, unstable sleep (low quality), sleep efficiency. 
- Blood and urine sampling including routine parameters: hemogram, 
glicosilated Hb, cardiovascular parameters including troponin, PIGF, 
NTproBNP and angiogenic factors, leukocytes, coagulation, lipid profile, 
liver and renal function, basic urine profile. Alkaline phosphatase (total 
and bone-specific), creatin kinase, osteocalcin and urinary N-terminal 
telopeptide will be also included. 
- Fetal hemodynamic parameters (measured by Doppler ultrasound) and 
maternal cardiovascular evaluation (measured by echocardiography: 
cardiac frequency, mean carotid thickness, subaortic integrated speed-
time flow, heartbeat volume, left cardiac output, vascular resistance)   
- Step count 
o Other parameters measuring mental health/emotional state. 
- RRS questionnaire to measure ruminative response.  
- LOT (life orientation test) questionnaire to measure perception of self-
control. 
- BFI-2- to measure negative emotionality trait.  

 
 
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- BDI-II to measure anhedonia. 
• 
Perinatal outcomes 
o Gestational age at delivery 
o Birthweight and percentile 
o SGA/growth restriction classification, if any 
o Mode of delivery (spontaneous, assisted, cesarean section) 
o 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) 
o Neonatal admission to neonatal intensive care unit (yes/no) 
o 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) 
o Breastfeeding rates at discharge and at 6 weeks follow-up 
 
4.2 
Description of methods and questionnaires  
 
Specifically designed exercise program: 
This will be an exercise program based on resistance/strength, specifically designed to be 
executed while in bed or minimal mobility. It is an adaptation from the exercise program 
described by Brun CR et al (Brun CR, Shoemaker JK, Bocking A, Hammond JA, Poole M, Mottola 
MF. Bed-rest exercise, activity restriction, and high-risk pregnancies: a feasibility study. Applied 
Physiology, Nutrition, and Metabolism. 2011;36(4):577-582). 
 
Physiological parameters:  
An accelerometer Actigraph GT3X-BT which will be worn by the individuals from recruitment to 
delivery or discharge from hospital. It will measure total daily mean time (min) of physical 
activity and percentage of daily time spent in inactivity, mild, moderate or vigorous activity. Also, 
mean sleep period time, unstable sleep (low quality), sleep efficiency and sleep average per 
night. Daily information will be retrieved. 
Handgrip test: Grip strength is one of the physical fitness tests included in the Adult Eurofit 
Physical Fitness Test Battery (Eurofit for adults book: Assessment of Health Related Fitness, 
Council of Europe Publishing, 1995) which is a set of physical fitness tests covering a range of 
fitness components, designed for testing adults of Europe. Grip strength is usually 
measured using a hand-held dynamometer. The patient squeezes the dynamometer with all of 
their strength, typically three times with each hand. An average score is then calculated using 
the measurements from both hands (Helen C et al, A review of the measurement of grip 
strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing 
(2011) 40 (4): 423-429). It has been used also as a screening for sarcopenia (when <18 kg in 
females, Chen LK at al, Asian Working Group for Sarcopenia: 2019 Consensus Update on 
Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2). 
Pre-test: Explain the test procedures to the subject. Prepare forms and record basic information 
such as age, height, body weight, gender, hand dominance. Calibrate dynamometer, adjust to suit 

 
 
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the subject. 
Procedure: The subject holds the dynamometer in the hand to be tested, with the arm at right 
angles and the elbow by the side of the body. The handle of the dynamometer is adjusted if 
required - the base should rest on the first metacarpal (heel of palm), while the handle should rest 
on middle of the four fingers. When ready the subject squeezes the dynamometer with maximum 
isometric effort, which is maintained for about 5 seconds. No other body movement is allowed. 
The subject should be strongly encouraged to give a maximum effort.  
Scoring: The best result from several trials for each hand is recorded, with at least 15 seconds 
recovery between each effort. The values listed below (in kg and lbs) give a guide to expected 
scores for adults.  
 
 
 
 
 
 
 
 
 
Calf Circumference measurement: AWGS’19 recommendations for sarcopenia screening 
includes the Calf Circumference measurement (Chen LK at al, Asian Working Group for 
Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir 
Assoc. 2020 Mar;21(3):300-307.e2). Although definition and diagnosis of sarcopenia are still 
evolving, sarcopenia has been defined as “age-related loss of muscle mass, plus low muscle 
strength, and/or low physical performance”.  Calf circumference provides information about 
normal muscle mass and overall can be a useful measure of an individual’s overall health and 
fitness level. Indeed, it can reflect a decrease in muscle mass when limited physical activity. 
However, measurements may be affected by errors of interpretation due to the presence of 
edema and possible connective and adipose tissue in place of muscle tissue. In our study, we 
will be based on the anthropometric reference data from the CDC:  
Procedure:  To accurately measure calf circumference, use a flexible tape measure like a tailor’s 
tape. Sit with your feet flat on the floor and wrap the measuring tape horizontally around your calf, 
moving it up and down to find the widest point: the horizontal circumference around the thickest 
part of the lower legs must be measured.  
Scoring:  

 
 
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From McDowell MA, Fryar CD, Ogden CL, Flegal KM. Anthropometric reference data for children and adults: United States, 2003–
2006. National health statistics reports; no 10. Hyattsville, MD: National Center for Health Statistics. 2008. Available from: 
http://www.cdc.gov/nchs/data/nhsr/nhsr010.pdf.   
Get Active questionnaire for pregnancy (GAQ-P) (https://csep.ca/2021/05/27/get-active-
questionnaire-for-pregnancy/) is a self-evaluation questionnaire of physical activity endorsed 
by the Canadian Society for Exercise Physiology (CSEP). The questionnaire, self-classifies how 
often and for how long she is engaged in physical activity of a light, moderate or vigorous 
intensity. Also, it addresses the question whether the woman should speak to her Obstetric 
Health Care Provider before beginning or continue to be physically active. 
 
Questionnaires to evaluate mental/emotional health: 
Mental/emotional health parameters: As main variables, three gold standard self-reported 
mental health questionnaires will be administered at baseline (w0), and afterwards every 2 
weeks until discharge or delivery in order to have an estimate of the impact of bed rest and the 
PA program on the mental functioning of patients. We expect to observe an amelioration in 
anxiety, perceived stress and depression scores along the completion of the program. Parallelly, 
a brief visual evaluation of mood will be self-administered daily in order to have a pattern of 
emotional fluctuation along the completion of the exercise program. Next, we specified the 
psychological measurement instruments. 
GAD-7: The generalized anxiety disorder assessment is a 7-item validated 
measurement scale that captures severity of anxiety symptoms. GAD-7 was originally 
used to identify General Anxiety Disorder according to DSM diagnostic criteria. 
However, it has also been extensively utilized as a dimensional measure of anxiety in 
different populations. Items are rated by means of a 4-point Likert Scale exploring 
frequency of the behavior worded in the item during the last 2 weeks. Total scores 
range from 0 to 21 with higher results indicating higher severity of anxiety.  
 
PSS-10: the Perceived Stress Scale is a 10-item test to evaluate stress perceived which 
will be administered along with the anxiety and depression measures. The 10-item 
Perceived Stress Scale (PSS) is an instrument used to evaluate the degree to which a 
given life situation can be appraised as stressful. Originally, PSS was designed to appraise 
the level of stress during the last month therefore to meet our objective, PSS-10 
instructions will be modified to cover explicitly the level of stress during the last two 
weeks. Responses are rated with a 5-point Likert scale with higher scores indicating 
severity of perceived stress and alterations at a cognitive and affective level. 
EPDS: The Edinburgh Postnatal Depression Scale is a 10-item questionnaire 
considered a gold-standard for identifying depression and emotional distress in the 
perinatal period. In Spanish speaking populations, a cutoff point of 10 indicates risk of 

 
 
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developing depression and a further need of clinical assessment and score ≥13 or 
answering item 10 positive, indicates high risk. Patients must rate the 10 items by 
means of a 4-point Likert scale. Total scores range from 0 to 30 with higher total 
indicating more intense emotional distress.  
 
SAM: The Self-Assessment Manikin is a visual standardized measure of emotional 
tone that covers 3 different affective domains (valence, arousal and sense of control). 
Completion requires less that 20 seconds and is highly suitable for individuals during 
hospital admission and bedrest. It can be used in many different contexts and the non-
verbal design allows its usage with handicapped or children populations. MAS presents 
a series of manikin pictures representing different intensities of the 3 affective 
domains. 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.  
 
Trait-Level variables: 
These are a set of further psychological trait-level parameters: the next questionnaires will be 
administered once at w0. They are intended to measure stable characteristics of the person that 
we estimate will mediate the adherence, satisfaction and positive health impact of the exercise 
intervention.  
RRS: The Ruminative Response Scale is a 10-item questionnaire intended to measure 
rumination, tendency to worriedness and repetitive thinking in front of stressful 
situations. It reflects a personality tendency considered a vulnerability trait for 
developing of common mental health conditions.  Reponses are rated on a 4-point 
Likert scale. Higher scores indicate a higher tendency to ruminate and represent a 
vulnerability trait to psychological distress. Total responses range from 10 to 40. 
LOT: The Life orientation test is a 10-item self-rated instrument measuring how 
optimistic a person feels about the future. High scores in optimism have been robustly 
associated to healthier behaviors protecting against cardiovascular diseases among 
other pathologies. It is a dimensional continuous measure describing a permanent trait 
of the person. Items are rated using a 5-point Likert scale. Total scores range from 0 to 
40. 
BFI-2: The negative emotionality trait will be evaluated at the beginning of the study to 
identify those individuals with proneness to negative thinking. This 6 -item brief 
personality questionnaire reflecting a scale of neuroticism will be administered. 
Responses are made by using a 6-point Likert scale, with higher scores indicating 
higher levels of negative thinking. 
BDI-II: BDI-II is a questionnaire 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. 
 
Questionnaires to evaluate quality of sleep and quality of life: 
Sleep average per night will be measured using the Actigraph GT3X-BT. 
Quality of sleep will be evaluated using the Spanish version of the Insomnia Severity 
Index (ISI) which is composed of seven items that evaluate the severity of sleep 
disturbance during the past 2 weeks. Each item is rated on a five-point Likert scale and 

 
 
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the total score indicates the severity of insomnia. Score 8-14 is mild and 15 or more 
moderate to severe insomnia), impact on daily life and treatment response. 
Quality of life will be evaluated using the Spanish version of the WHOQOL-BREF which 
assesses 4 domains of quality of life regarding the last two weeks: physical health, 
psychological health, social relationships, and environment.  physical health (7 items), 
psychological health (6 items), social relationships (3 items), and environmental health 
(8 items); it also contains QOL and general health items. Each individual item of the 
WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five- 
point ordinal scale. The scores are then transformed linearly to a 0–100-scale. There is 
not a standard cut-off proposed but the higher the score, the higher the quality of life. 
 
 

 
 
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5 
Study design 
Given the scarce information about the variables proposed in these kind of subjects 
(pregnant people with complications and hospitalized in almost complete bedrest, we will follow 
a two-step study: 
We will conduct a pilot randomized controlled study including pregnant women 
admitted to the Maternal Intermediate Care Unit in the Maternal-Fetal Medicine Department 
of the Hospital Clinic. Two groups of pregnant women will be studied depending on the exposure 
to the specific designed exercise program: 
No-exercise group (NEG): women admitted in the Maternal Intermediate Care Unit who 
will follow the standard management for its complication. 
Exercise group (EG): women admitted in the Maternal Intermediate Care Unit who will 
follow the standard management for its complication and will follow a specific designed 
exercise program. 
The abovementioned variables will be evaluated, and dimension of differences 
considered. If appropriate, a focus-group will be designed in order to determine clinical 
relevant variables and differences and its effect-size to assess future sample-size calculations. 
 
A full RCT study will be designed and conducted in a second-step with an appropriate 
sample size to evaluate the key variables selected considering the recruitment rate and other 
findings extracted from the pilot study. 
 
 

 
 
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6 
Participants selection 
Pregnant women admitted in the Maternal Intermediate Care Unit who have remained 
stable of her complication after 24-48h of admission will be approached by the investigators to 
participate in the study. If informed consent form signed, they will be randomized and included 
in the no-exercise group or exercise group:  
6.1 
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. 
 
6.2 
Exclusion criteria  
Fetal death 
Severe mental health disorders and substance abuse disorders. 
 
 
 

 
 
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7 
Treatment or development of the study 
Role of the investigators: 
MP and EFV-B designed the study because their expertise in clinical Maternal-fetal 
Medicine and Sports Medicine, respectively. FM and FF provided assessment in the study design. 
RB provided assessment to the exercise program because of his expertise in physical activity; 
AM and XS provided assessment on the emotional/psychological field and will run the evaluation 
in this area; GR provided assessment because of his expertise in Sports Medicine. 
MP will be supervising the clinical management. MP, FM, FF, AJ and EG will participate 
to evaluate eligibility and recruitment of the participants. EFV-B and SE will be supervising the 
exercise program execution. EFV-B, SE, EG and AJ will be in charge to explain the exercise 
program to participants and will evaluate its adherence or barriers to develop the program. MP, 
FM, FF, AJ, EG, AM and XS will retrieve clinical information from clinical files when needed.  
All investigators participated, reviewed, and approved the proposal and development of 
the study. 
Vital parameters:  
Systolic and diastolic pressure, heart rate and temperature will be taken as part of the 
routine management, three times a day (8:00±2h, 16:00±2h, 24:00±2h) until delivery or 
discharge. No additional measurements will be taken because of this study. 
Blood sampling parameters, fetal hemodynamic parameters and maternal 
echocardiographic parameters will be measured at wk0 (recruitment), wk1±2d, wk2±2d, 
wk3±2d, and weekly until delivery, following routine care. No additional blood sampling will be 
carried out because of this study but alkaline phosphatase (total and bone-specific), creatin 
kinase, osteocalcin and urinary N-terminal telopeptide, glicosilated Hb, cardiovascular 
parameters including troponin, sFlt-1, PIGF, NTproBNP, will be added to the routine analysis. 
An accelerometer Actigraph GT3X-BT will be worn by the individuals from recruitment 
to delivery or discharge from hospital. It will measure daily mean time (min) of activity and 
percentage of daily time spent in inactivity, mild, moderate or vigorous activity. Also, mean 
sleep period time, unstable sleep (low quality), sleep efficiency and sleep average per night. 
Daily information will be retrieved.  
Participants included in the exercise group will be trained to execute once daily 
(estimated duration 30 minutes) the specifically designed exercise program by investigators 
specialists in Sports Medicine and in Physiotherapy. Midwives in charge of the maternal-fetal 
unit will be running the follow up. Investigators specialist in Maternal-fetal medicine will be in 
charge of the clinical management and decisions. 
Validated Spanish versions of the questionnaires evaluating mental/emotional health 
and quality of sleep and life will be used. Investigators specialized in psychology will be in charge 
of this part. The three gold-standard self-reported mental health questionnaires will be run at 
wk0, wk2+/-2d and then every 2 weeks until discharge or delivery and at 6+/-1 weeks 
postpartum. The SAM questionnaire will be run daily. Questionnaires measuring psychological 
trait-level parameters will be run once at wk0. Quality of sleep and life questionnaires will be 
run at wk0, wk2+/-2d and then every 2 weeks until discharge or delivery. 
 
 

 
 
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CHRONOGRAM IN THE NO-EXERCISE/EXERCISE GROUPS 
w0 
No-exercise group 
Exercise group 
Maternal and fetal baseline characteristics 
Maternal and fetal baseline characteristics 
Blood sampling and fetal/maternal workout 
Blood sampling and fetal/maternal workout 
Mental/emotional health evaluation 
Mental/emotional health evaluation 
Trait level parameters evaluation 
Trait level parameters evaluation 
Sleep and quality of life evaluation 
Sleep and quality of life evaluation 
Actigraph activation 
Actigraph activation 
 
Training in the Exercise Program: 30 minutes daily 
 
w0+3d and every wN +3d until discharge or delivery whichever occurs first. 
No-exercise group 
Exercise group 
Maternal and fetal standard management 
Maternal and fetal standard management 
 
Checking follow up of Exercise Program 
 
 
 
Daily 
No-exercise group 
Exercise group 
SAM questionnaire 
SAM questionnaire 
 
 
 
 
w1 
No-exercise group 
Exercise group 
Blood sampling and fetal/maternal workout 
Blood sampling and fetal/maternal workout 
Maternal and fetal standard management 
Maternal and fetal standard management 
Actigraph retrieval of information 
Actigraph retrieval of information 
 
Checking follow up of Exercise Program 
 
w2 
No-exercise group 
Exercise group 
Blood sampling and fetal/maternal workout 
Blood sampling and fetal/maternal workout 
Mental/emotional health evaluation 
Mental/emotional health evaluation 
Sleep and quality of life evaluation 
Sleep and quality of life evaluation 
Actigraph retrieval of information 
Actigraph retrieval of information 
 
Checking follow up of Exercise Program 
 
w3, w5 and odd weeks of follow up until discharge or delivery whichever occurs first. 
 
 
As in w1 
w4, w6 and even weeks of follow up until discharge or delivery whichever occurs first. 
 
 
As in w2  
 
 
Delivery 
No-exercise group 
Exercise group 
Perinatal outcomes 
Perinatal outcomes 
Mental/emotional health evaluation (if even week) 
Mental/emotional health evaluation (if even week) 
Sleep and quality of life evaluation (if even week) 
Sleep and quality of life evaluation (if even week) 
Actigraph retrieval of information 
Actigraph retrieval of information 
 
Feasibility information about Exercise Program 
 
Satisfaction information about Exercise Program 
 
6 weeks postpartum 
No-exercise group 
Exercise group 
Mental/emotional health evaluation 
Mental/emotional health evaluation 
Blood sampling and fetal/maternal workout 
Blood sampling and fetal/maternal workout 
Postpartum and mental/emotional health evaluation 
Postpartum and mental/emotional health evaluation 
 
 
 

 
 
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8 
Statistical analyses 
8.1 
Sample size 
As a first step, this is a pilot study planned to evaluate dimension of differences in this 
clinical context. Potential recruitment, adherence and feasibility of a regular exercise program 
in this context will be evaluated. For this first step we plan to include 10 women in the no-
exercise group (NEG) and 10 women in the exercise group (EG).  
Variables proposed will be evaluated and dimension of differences considered. If 
appropriate, a focus-group will be designed in order to determine relevant clinical differences. 
Finally, effect-size to assess sample-size calculations will be used to design the second step of 
the study. 
A RCT study with the appropriate sample size to evaluate key variables and considering 
the recruitment rate and other findings extracted from the pilot study will be conducted on 
subjects with the same inclusion/exclusion criteria described. 
 
8.2 
Statistical analysis 
As a general rule, qualitative variables will be described as absolute frequencies and 
relative percentages and quantitative variables as means and medians for the assessment of 
central tendency and SD and IQR for the assessment of dispersion. Univariate analysis: for the 
comparison of two qualitative variables, the χ2 test or Fisher’s exact test will be used. When 
the variables are quantitative, Student’s t-test for independent samples or the Mann-Whitney 
U test will be used if the applicability criteria are not met. For statistical analysis, values of 
p<0.05 will be considered as statistically significant. The data will be analyzed with the SPSS 
software (V.20.0, IBM or newer). 
The randomization of participants will be conducted using a simple randomization 
method to ensure an equal and unbiased distribution between the treatment and control 
groups. A pseudorandom number generator will be utilized to create the randomization list. 
This list will be generated using specialized software to assign participants to either the 
treatment group or the control group in a 1:1 ratio. To maintain the integrity and 
confidentiality of the randomization process, the randomization list will be securely 
administered by the study sponsor. It will be stored in a password-protected file accessible 
only to authorized personnel. This approach ensures that the randomization process remains 
blinded and reduces the risk of allocation bias. 
 
 

 
 
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9 
Ethics 
The study will be carried out in compliance with the Declaration of Helsinki (current 
version; currently Fortaleza, Brazil, October 2013) and in accordance with the protocol and legal 
requirements expressed in Law 14/2007 of July 3, on Biomedical Research. 
Informed consent will be requested from patients before inclusion in the study. Consent 
from both parents will be obtained to be able to use the clinical information of the 
fetus/newborn. 
 
 

 
 
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10 Data management plan. 
Data will not be reused from other studies as there is no available data of this 
characteristics. All data of this study will be codified and collected in a dedicated database based 
on the REDCap® platform hosted in the Coordinating center (Hospital Clínic). This database will 
have limited access through username and password of authorized personnel. The coding table 
will be kept password-protected and under the supervision of the sponsor. 
Personal characteristics, information about pregnancy complications, delivery, cesarean 
section rate, neonatal adverse outcomes, maternal morbidity and hospital stay will be collected 
for all women included in the trial, independently on their group. Effort will be made to follow 
FAIR principles (Findable, Accessible, Interoperable and Reusable).   
Researchers who access this database will be responsible for the confidentiality of the 
data collected. In this database, a code will be assigned to each case to enter the other variables 
in a database without any information that can identify the patient or study subject. These 
measures are intended to ensure compliance with the provisions of Organic Law 3/2018, of 5 
December, on the Protection of Personal Data and the guarantee of digital rights.  
Data analysis will be managed from investigators from the Coordinating center who will 
be also the ones to carry out clinical interpretation of the data analysis. 
 
 

 
 
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11 
Data processing and data file. Data confidentiality.  
The data will be collected in a REDCap® database specifically designed for the study that 
will be kept by the researchers. The data will later be extracted and analyzed to obtain results. 
The processing, communication and transfer of personal data of all participants will 
comply with EU Regulation 2016/679 of the European Parliament and of the Council of April 27, 
2016 regarding the protection of natural persons regarding to the processing of personal data 
and the free circulation of data, and to Organic Law 3/2018, of December 5, on the Protection 
of Personal Data and guarantee of digital rights. The legal basis that justifies the processing of 
your data is the consent you give in this act, in accordance with the provisions of article 9 of EU 
Regulation 2016/679. 
The data for these studies will be collected only identified by a code, so no type of 
information that allows identifying the participants will be included. Only the study doctor and 
his collaborators with the right of access to the source data (medical history) will be able to 
relate the data collected in the study with the patient's medical history. 
The identity of the participants will not be accessible to any other person except in a 
medical emergency or legal requirement. 
The health authorities, the Research Ethics Committee and personnel authorized by the 
study promoter may have access to the identified personal information, when necessary to 
verify data and procedures of the study, but always maintaining confidentiality in accordance 
with current legislation. 
Only the encrypted data will be transferred to third parties and other countries, which 
in no case will contain information that can identify the participant directly (such as name and 
surname, initials, address, social security number, etc.). In the event that this transfer occurs, it 
would be for the same purpose of the study described and guaranteeing confidentiality. 
If a transfer of encrypted data is carried out outside the EU, either in entities related to 
the hospital center where the patient participates, to service providers or to researchers who 
collaborate with us, the participants' data will be protected by safeguards such as contracts or 
other mechanisms established by data protection authorities. 
As promoters of the project, we undertake to process the data in accordance with EU 
Regulation 2016/679 and, therefore, to maintain a record of the processing activities that we 
carry out and to carry out a risk assessment of the treatments that we carry out. , to know what 
measures we will have to apply and how to do it. 
In addition to the rights already contemplated by the previous legislation (access, 
modification, opposition and cancellation of data, deletion in the new Regulation) participants 
can now also limit the processing of data collected for the project that is incorrect, request a 
copy or transferred to a third party (portability). To exercise these rights, you must contact the 
principal investigator of the study or the Data Protection Delegate of the Hospital Clínic of 
Barcelona through protecciodades@clinic.cat. You also have the right to contact the Data 
Protection Agency if you are not satisfied. to. 
Data cannot be deleted, even if a patient drops out of the study, to ensure the validity 
of the research and to comply with legal duties and drug authorization requirements. 

 
 
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The Researcher and the Sponsor are obliged to retain the data collected for the study 
for at least 5 years after its completion. Subsequently, personal information will only be retained 
by the health care center and by the sponsor for other scientific research purposes if the patient 
has given consent to do so, and if permitted by applicable law and ethical requirements. 
 
 

 
 
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12 
 Management of biological samples 
For this pilot study no samples will be stored 
13 
Funding   
There is no specific financial support for this study. All interventions and measurements 
will be carried out in the context of the clinical management. 
14 
Publication policy  
This is a pilot study and findings are to be evaluated. As well feasibility of the study has 
yet to be determined. Depending on the quality of data, investigators will take care for results 
from this study being published in peer-reviewed journals.