PregnancyNCT05904925
Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy
A study testing Pilates exercises in people with Pregnancy, run by Universidade Cidade de Sao Paulo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women of usual risk in the 12th gestational week (gestational age determined by the date of the last menstruation or by the ultrasound examination)
- with medical clearance to practice physical activity
Who cannot join
- practice of other physical activity during pregnancy
- any medical contraindications, such as diabetes and hypertension
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilates Exercises for the Prevention of Musculoskeletal Complaints During Pregnancy: a Protocol of a Pilot Randomized Controlled Trial With Economic Evaluation
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.
- Conditions
- Pregnancy
- Being tested
- Pilates exercises
- Keywords
- Pilates, Pregnancy, Randomized controlled trial, Pilot study, Musculoskeletal complaint, Economic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet. |
| Pilates | Active comparator | 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. Receives: Other: Pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From 7 to 15 days after delivery
Secondary outcomes (9)
Occurrence of musculoskeletal complaint
Measured: 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
Measured: 24th gestational week, 36th gestational week, and from seven to 15 days after delivery
Delivery mode (normal or caesarean section)
Measured: 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
Measured: From 7 to 15 days after delivery
Baby's birth weight
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline, 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Maria Nunes Cabral, Universidade Cidade de Sao Paulo
- Investigators
- Cristina MN Cabral, PhD, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904925
- Sponsor's protocol ID
- 59486822.3.0000.8084
- Status last verified
- Jun 2023
- First submitted
- 18 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Exercises for the Prevention of Musculoskeletal Complaints During Pregnancy: a Protocol of a Pilot Randomized Controlled Trial With Economic Evaluation
- ClinicalTrials.gov ID
- NCT05904925
- Acronym / sponsor ID
- 59486822.3.0000.8084
- Conditions
- Pregnancy
- Keywords
- Pilates, Pregnancy, Randomized controlled trial, Pilot study, Musculoskeletal complaint, Economic evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet. |
| Pilates | Active comparator | Other: Pilates exercisesPilates 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women of usual risk in the 12th gestational week (gestational age determined by the date of the last menstruation or by the ultrasound examination)
- with medical clearance to practice physical activity
Key exclusion criteria (2 listed)
- practice of other physical activity during pregnancy
- any medical contraindications, such as diabetes and hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesSessions 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. | Other | Pilates |
Primary outcome
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
Time frame: 24th gestational week
The participant's perception of the treatment result being satisfactory
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
Time frame: 36th gestational week
The participant's perception of the treatment result being satisfactory
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
Time frame: From 7 to 15 days after delivery
The participant's perception of the treatment result being satisfactory
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)
Time frame: 24th gestational week
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
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)
Time frame: 36th gestational week
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
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)
Time frame: From 7 to 15 days after delivery
Assesses whether the exercise program is suitable for the target audience or needs some adaptation
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Time frame: 24th gestational week
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Time frame: 36th gestational week
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
Time frame: From 7 to 15 days after delivery
Assesses recruitment, retention, and participation rates, whether participants reached the end of the treatment program and, if not, why they dropped out
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Time frame: 24th gestational week
Assesses the level of difficulty of the selected exercises
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Time frame: 36th gestational week
Assesses the level of difficulty of the selected exercises
Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
Time frame: From 7 to 15 days after delivery
Assesses the level of difficulty of the selected exercises
9 secondary outcomes
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)
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina MN Cabral, PhD principal investigator
Universidade Cidade de São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises in people with Pregnancy, run by Universidade Cidade de Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina MN Cabral, PhD (55 11 21781214, cristina.cabral@unicid.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results) (time frame: 24th gestational week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.