Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

NCT ID: NCT05904925

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Usual care

Usual care group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pilates

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.

Group Type: ACTIVE_COMPARATOR

Pilates exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cristina Maria Nunes Cabral

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina MN Cabral, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Central Contacts

Cristina MN Cabral, PhD

Role: CONTACT

cristina.cabral@unicid.edu.br

55 11 21781214

Other Identifiers

59486822.3.0000.8084

Identifier Type: -

Identifier Source: org_study_id