High-Risk Pregnancy
Conditions
Keywords
hospitalized, activity restriction, bed rest, antepartum, pregnant, high risk
Brief summary
The current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. High levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. The proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. We hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.
Interventions
OTHERMusic Intervention
Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.
OTHERMuscle Conditioning Intervention
Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones and also participate in the muscle conditioning program while in bed.
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized high-risk pregnant women in hospital for at least 7 days * Diagnosed with gestational hypertension * Diagnosed with preeclampsia (mild to moderate) * Diagnosed with intrauterine growth restriction * Single baby * Expecting twins * Expecting triplets * Diagnosed with shortened cervix * Diagnosed with threatened pre-term labour (not actively contracting)
Exclusion criteria
* Diagnosed with symptomatic placenta previa (bleeding) * Diagnosed with severe pre-eclampsia (immediate delivery) * Diagnosed with conditions indicating a short term hospital stays of less than 7 days * Diagnosed with infections * Diagnosed with heart and renal disease * Diagnosed with diabetes * Diagnosed with metabolic bone disease * Diagnosed with hyper-or-hypo-thyroidism * Diagnosed with Cushing disease and anemia * Women carrying more than 3 babies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Functional Mobility Assessment Tool | 2 weeks post delivery | The Functional Mobility Assessment Tool was adapted from a senior fitness test, which uses 7 tests to assess muscular strength, aerobic endurance, flexibility and agility (Chair Stand Test, Arm Curl Test, 6-Minute Walk Test, 2-Minute Step Test, Chair Sit-And-Reach Test, Back Scratch Test, and 8-Foot-Up-And-Go Test). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery | The secondary outcome of the study is to examine quality of life in the postpartum period. Quality of life will be measured by completing four surveys the EQ-5D, and the Postpartum Psychological Profile Questionnaire which includes the Depression Scale (1 page), the State Anxiety Index (1 page) and the Postpartum Physical and Psychological Symptoms Report . |
| Follow up to Primary outcome Score for Functional Mobility Assessment Tool | 2, 6 and 12 months | Changes over time within groups and between groups in the post partum period |
Countries
Canada
Outcome results
None listed