An interventional study of Pilates exercises in Pregnancy, sponsored by Universidade Cidade de Sao Paulo. Not yet recruiting. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Other
The goal of this pilot randomized controlled trial with economic evaluation is to evaluate the viability of Pilates in the prevention of musculoskeletal complaints, throughout the entire gestational period, in pregnant women. The main question it aims to answer is if it is feasible to perform exercises during the entire gestational period to prevent musculoskeletal disorders. Participants will be assessed primarily for acceptability, suitability, feasibility, and fidelity, and secondarily for the occurrence of musculoskeletal complaint and the number of days from randomization on which this musculoskeletal complaint occurred, type of delivery and costs. Then, participants will be randomized into two groups: the usual care group, which will receive an educational booklet with information about the usual care during pregnancy, and the Pilates group, which will receive the same educational booklet and will participate in a specific Pilates exercise program for the gestational period, twice a week, throughout the pregnancy.
Universidade Cidade de Sao Paulo is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet.
Pilates group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet. Additionally, this group will receive an exercise program based on Pilates, twice a week, individually, throughout the gestational period.
Other: Pilates exercises
Sessions will last 60 minutes: five minutes for warming up, 50 minutes for the practice of Pilates exercises, and five minutes for relaxing with the Swiss ball. The exercise protocol will be divided into three gestational phases, covering the entire gestational period, with different and specific objectives for each phase. In all phases, the exercises will be classified into three levels of difficulty: basic, intermediate, and advanced, according to the evolution of each pregnant woman throughout the practice of Pilates. Modifications will be allowed to facilitate or hinder the execution of the movement. The exercises will be performed in one or two sets of seven to 10 repetitions. The number of series, repetitions and exercises and interval time between them, as well as the level of difficulty of the exercises, will be gradually adjusted. The intensity of the exercises will vary between light and moderate and will be controlled by the Borg scale.
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
The participant's perception of the treatment result being satisfactory
Time frame: 24th gestational week
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
The participant's perception of the treatment result being satisfactory
Time frame: 36th gestational week
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
The participant's perception of the treatment result being satisfactory
Time frame: From 7 to 15 days after delivery
Suitability measured using 2 questions (one about the need of tailored exercises for the gestational needs and the other about the need of some adaptation during the execution of the exercises)
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
Time frame: 24th gestational week
Suitability measured using 2 questions (one about the need of tailored exercises for the gestational needs and the other about the need of some adaptation during the execution of the exercises)
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
Time frame: 36th gestational week
Suitability measured using 2 questions (one about the need of tailored exercises for the gestational needs and the other about the need of some adaptation during the execution of the exercises)
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
Time frame: From 7 to 15 days after delivery
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Time frame: 24th gestational week
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Time frame: 36th gestational week
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Time frame: From 7 to 15 days after delivery
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Assesses the level of difficulty of the selected exercises
Time frame: 24th gestational week
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Assesses the level of difficulty of the selected exercises
Time frame: 36th gestational week
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Assesses the level of difficulty of the selected exercises
Time frame: From 7 to 15 days after delivery
Occurrence of musculoskeletal complaint
Time frame: 24th gestational week, 36th gestational week, and from seven to 15 days after delivery
Number of days from randomization on which the musculoskeletal complaint occurred
Time frame: 24th gestational week, 36th gestational week, and from seven to 15 days after delivery
Delivery mode (normal or caesarean section)
Time frame: From 7 to 15 days after delivery
Apgar score (0 to 10)
Reported at 1 minute and 5 minutes after birth, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7
Time frame: From 7 to 15 days after delivery
Baby's birth weight
Time frame: From 7 to 15 days after delivery
Kinesiophobia measured using the Tampa Scale of Kinesiophobia in the occurrence of musculoskeletal complaint
The total score ranges from 17 to 68 points, and the higher the score, the greater the degree of kinesiophobia.
Time frame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
Disability measured using the Patient Specific Functional Scale in the occurrence of musculoskeletal complaint
11-point numerical scale (0 = unable to perform the activity; 10 = able to perform the activity at the same level as before the injury or problem)
Time frame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
Pain measured using the Pain Numerical Rating Scale in the occurrence of musculoskeletal complaint
11-point numerical scale (0 = no pain; 10 = the worst possible pain)
Time frame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
Costs (healthcare costs, patient and family costs, and lost productivity costs) measured using a questionnaire specially developed for this study
Time frame: Baseline, 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Jun 2024, 11 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Universidade Cidade de Sao Paulo