Pilates Exercises for the Prevention of Musculoskeletal Complaints During Pregnancy: a Protocol of a Pilot Randomized Controlled Trial With Economic Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Acceptability measured using a 11-point numerical scale (0 = completely dissatisfied with the treatment results; 10 = completely satisfied with the treatment results)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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: 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: 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: From 7 to 15 days after delivery
Assesses the level of difficulty of the selected exercises
Secondary Outcomes
- 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)
- Baby's birth weight(From 7 to 15 days after delivery)
- Apgar score (0 to 10)(From 7 to 15 days after delivery)
- Occurrence of musculoskeletal complaint(24th gestational week, 36th gestational week, and from seven to 15 days after delivery)
- Pain measured using the Pain Numerical Rating Scale in the occurrence of musculoskeletal complaint(24th gestational week, 36th gestational week, and from 7 to 15 days after delivery)
- Kinesiophobia measured using the Tampa Scale of Kinesiophobia in the occurrence of musculoskeletal complaint(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(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)
Investigators
Cristina Maria Nunes Cabral
Professor
Universidade Cidade de Sao Paulo