Motor Control Exercise Program for Pregnant Women With a History of Lumbopelvic Pain
- Conditions
- Lumbopelvic Pain
- Interventions
- Other: Motor control exercise program
- Registration Number
- NCT04253717
- Lead Sponsor
- Université du Québec à Trois-Rivières
- Brief Summary
This study protocol was designed to establish the feasibility of conducting a motor control exercise program with pregnant women presenting a history of lumbopelvic pain (LBPP) in order to reduce LBPP occurrence or limit its intensity. This randomized controlled trial also aims to preliminary assess the effectiveness of the program. To do so, 40 pregnant women with a history of LBPP will be recruited and randomly allocated to one of 2 groups: control (20 participants) or intervention (20 participants). The control group will receive standard care, including basic information on what to do when suffering from LBPP. The intervention group will participate in a weekly 40-minute group session and two more 40-minute weekly home exercise sessions. The motor control exercise program will be designed to target strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and protection of the spine and pelvis. Participants of this group will also receive standard care. Adequate prevention and treatment of LBPP, experienced by women during pregnancy, should help reduce LBPP occurrence or limit its intensity during pregnancy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
- Being pregnant of one fetus
- Being ≤ 20 weeks pregnant
- Presenting a history of lumbopelvic pain
- Inflammatory rheumatic disease
- Infectious disease
- Neuromuscular disease
- Vascular disease
- Connective tissue disease
- Severe disabling pain
- Neurologic signs and symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motor control exercise program Motor control exercise program Participants will be physically trained during pregnancy and will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.
- Primary Outcome Measures
Name Time Method Adherence rate Baseline (Post-intervention) Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Retention rate Baseline (Post-intervention) Defined as the completion of follow-up questionnaire by ≥ 80% of women
Safety of the intervention Week 16 (Post-intervention) Determined based on the number of adverse events and defined as nature of adverse events
Acceptability of the intervention Week 16 (Post-intervention) Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)
Recruitment rate Baseline (Pre-intervention) Defined as the ability to recruit 40 eligible women, willing to participate to the study
- Secondary Outcome Measures
Name Time Method Depression Baseline (Pre-intervention) and week 16 (Post-intervention) Assessed using the Beck Depression Inventory (BDI) (score range from 0 (minimum) to 63 (maximum) : higher score mean a worst outcome)
Lumbopelvic pain (incidence and frequency) Week 16 (Post-intervention) Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Lumbopelvic pain (intensity) Week 16 (Post-intervention) Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Functional disability Baseline (Pre-intervention) and week 16 (Post-intervention) Assessed using the Pelvic Girdle Questionnaire (PGQ) (score range from 0 (minimum) to 75 (maximum) : higher score mean a worst outcome)
Fear avoidance behaviors Baseline (Pre-intervention) and week 16 (Post-intervention) Assessed using the Tampa Scale of Kinesiophobia (TSK) (score range from 17 (minimum) to 68 (maximum) : higher score mean a worst outcome)
Level of anxiety Baseline (Pre-intervention) and week 16 (Post-intervention) Assessed using the State-Trait Anxiety Inventory (STAI) (score range from 20 (minimum) to 80 (maximum) : higher score mean a worst outcome)
Physical activity levels Baseline (Pre-intervention) and week 16 (Post-intervention) Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ) (weekly energy expenditure (MET-h·week-1), score range from 0 (minimum) to 1631 (maximum) : higher score mean a more active person)
Trial Locations
- Locations (1)
Université du Québec à Trois-Rivières
🇨🇦Trois-Rivières, Quebec, Canada