Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
This trial is active, not recruiting.
|Treatments||music intervention, muscle conditioning intervention|
|Sponsor||University of Western Ontario, Canada|
|Start date||October 2014|
|End date||November 2016|
|Trial size||30 participants|
|Trial identifier||NCT02239341, 105699|
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.
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Score on the Functional Mobility Assessment Tool
time frame: 2 weeks post delivery
Quality of life
time frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery
Follow up to Primary outcome Score for Functional Mobility Assessment Tool
time frame: 2, 6 and 12 months
Female participants at least 18 years old.
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
|Official title||Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.|
|Principal investigator||Michelle F Mottola, PhD|
Call for more information