Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.

NCT02239341 | Completed

• 1 other identifier: 105699
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Risk Pregnancy

Keywords

hospitalized; activity restriction; bed rest; antepartum; pregnant; high risk

Outcome Measures

Primary Outcomes (1)

• Score on the Functional Mobility Assessment Tool

  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).

  2 weeks post delivery

Secondary Outcomes (2)

• Quality of life

  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

  2, 6 and 12 months

Study Arms (2)

Music Intervention (M)

ACTIVE COMPARATOR

The M intervention will be 30 minutes (same amount of time as E group), but the participants will simply be listening to the same music in bed with no exercise component. They will be wearing the heart rate monitor as in the E group. The M group will act as a control group for the E group.

Other: Music Intervention

Muscle Conditioning Intervention (E)

EXPERIMENTAL

E (exercise) is 30 minutes in length and will consist of 5 minutes of warm-up, 20 minutes of light strengthening exercises using a theraband, and 5 minutes of cool-down. All exercises will be completed in bed. Each participant will be listening to the same music (as the M group) during exercise. A heart rate monitor will be worn throughout each session. The first session for each participant will be used to complete baseline measurements and to assess initial muscle strength. Difficulty level will be adjusted by using different strength therabands.

Other: Music Intervention; Other: Muscle Conditioning Intervention

Interventions

Music Intervention OTHER

Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.

Muscle Conditioning Intervention (E); Music Intervention (M)

Muscle Conditioning Intervention OTHER

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.

Muscle Conditioning Intervention (E)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Officials

• Michelle F Mottola, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 12, 2014
• Study Start: October 30, 2014
• Primary Completion: November 30, 2017
• Study Completion: December 30, 2017
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

CA (1)