Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: Pilates exercises

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina MN Cabral, PhD; Phone Number: 55 11 21781214; Email: cristina.cabral@unicid.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual care group will perform the usual prenatal care indicated by the obstetrician and will receive an educational booklet.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	From 7 to 15 days after delivery
Baby's birth weight		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.	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)	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)	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		Baseline, 24th gestational week, 36th gestational week, and from 7 to 15 days after delivery

Collaborators and Investigators

• Sponsor: Universidade Cidade de Sao Paulo
• Investigators: Principal Investigator: Cristina MN Cabral, PhD, Universidade Cidade de Sao Paulo

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Randomized controlled trial; Pilates; Pilot study; Economic evaluation; Musculoskeletal complaint
• Other Study ID Numbers: 59486822.3.0000.8084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No