Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

NCT05904925 | Unknown DMC

• 1 other identifier: 59486822.3.0000.8084
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pilates; Pregnancy; Randomized controlled trial; Pilot study; Musculoskeletal complaint; Economic evaluation

Outcome Measures

Primary Outcomes (12)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  From 7 to 15 days after delivery

Secondary Outcomes (9)

• Occurrence of musculoskeletal complaint

  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

  24th gestational week, 36th gestational week, and from seven to 15 days after delivery

• Delivery mode (normal or caesarean section)

  From 7 to 15 days after delivery

• Apgar score (0 to 10)

  From 7 to 15 days after delivery

• Baby's birth weight

  From 7 to 15 days after delivery

Study Arms (2)

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.

Other: Pilates exercises

Interventions

Pilates exercises 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.

Pilates

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Cristina MN Cabral, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina MN Cabral, PhD

CONTACT

55 11 21781214; cristina.cabral@unicid.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06