Clinical trial NCT05904925: Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy
Official title: Pilates Exercises for the Prevention of Musculoskeletal Complaints During Pregnancy: a Protocol of a Pilot Randomized Controlled Trial With Economic Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Pilates
Pregnancy
Randomized controlled trial
Pilot study
Musculoskeletal complaint
Economic evaluation
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* practice of other physical activity during pregnancy
* any medical contraindications, such as diabetes and hypertension

Primary outcomes:
measure: Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
timeFrame: 24th gestational week
measure: Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
timeFrame: 36th gestational week
measure: Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
timeFrame: From 7 to 15 days after delivery
measure: 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)
timeFrame: 24th gestational week
measure: 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)
timeFrame: 36th gestational week
measure: 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)
timeFrame: From 7 to 15 days after delivery
measure: Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
timeFrame: 24th gestational week
measure: Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
timeFrame: 36th gestational week
measure: Viability measured using a form developed for this study and filled by the physical therapist responsible for the treatment
timeFrame: From 7 to 15 days after delivery
measure: Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
timeFrame: 24th gestational week
measure: Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
timeFrame: 36th gestational week
measure: Fidelity measured using an exercise checklist (list of all exercises that can be performed including the level of difficulty)
timeFrame: From 7 to 15 days after delivery
Secondary outcomes:
measure: Occurrence of musculoskeletal complaint
timeFrame: 24th gestational week, 36th gestational week, and from seven to 15 days after delivery
measure: Number of days from randomization on which the musculoskeletal complaint occurred
timeFrame: 24th gestational week, 36th gestational week, and from seven to 15 days after delivery
measure: Delivery mode (normal or caesarean section)
timeFrame: From 7 to 15 days after delivery
measure: Apgar score (0 to 10)
timeFrame: From 7 to 15 days after delivery
measure: Baby's birth weight
timeFrame: From 7 to 15 days after delivery
measure: Kinesiophobia measured using the Tampa Scale of Kinesiophobia in the occurrence of musculoskeletal complaint
timeFrame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
measure: Disability measured using the Patient Specific Functional Scale in the occurrence of musculoskeletal complaint
timeFrame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
measure: Pain measured using the Pain Numerical Rating Scale in the occurrence of musculoskeletal complaint
timeFrame: 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
measure: Costs (healthcare costs, patient and family costs, and lost productivity costs) measured using a questionnaire specially developed for this study
timeFrame: Baseline, 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Cristina MN Cabral, PhD
role: PRINCIPAL_INVESTIGATOR
References: