Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Score on the Functional Mobility Assessment Tool
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Score on the Functional Mobility Assessment Tool
时间窗: 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).
次要结局
- Follow up to Primary outcome Score for Functional Mobility Assessment Tool(2, 6 and 12 months)
- Quality of life(Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery)
研究者
Michelle Mottola
Dr.
University of Western Ontario, Canada