High-Risk PregnancyNCT02239341
Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
A study testing Music Intervention and Muscle Conditioning Intervention in people with High-Risk Pregnancy, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-Risk Pregnancy
- What is being tested?
- Music Intervention and Muscle Conditioning Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2014to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Expecting triplets
- Diagnosed with shortened cervix
- Diagnosed with threatened pre-term labour (not actively contracting)
Who cannot join
- 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
Show all 10Show fewer
- Diagnosed with metabolic bone disease
- Diagnosed with hyper-or-hypo-thyroidism
- Diagnosed with Cushing disease and anemia
- Women carrying more than 3 babies
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Music Intervention, Muscle Conditioning Intervention
- Keywords
- hospitalized, activity restriction, bed rest, antepartum, pregnant, high risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.
Muscle Conditioning InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music Intervention; Other: Muscle Conditioning Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks post delivery
Secondary outcomes (2)
Quality of life
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 .
Measured: 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
Changes over time within groups and between groups in the post partum period
Measured: 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start30 Oct 2014
- Primary completion30 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk PregnancyStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Mottola, University of Western Ontario, Canada
- Investigators
- Michelle F Mottola, PhD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239341
- Sponsor's protocol ID
- 105699
- Status last verified
- Dec 2023
- First submitted
- 8 Sep 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
- ClinicalTrials.gov ID
- NCT02239341
- Acronym / sponsor ID
- 105699
- Conditions
- High-Risk Pregnancy
- Keywords
- hospitalized, activity restriction, bed rest, antepartum, pregnant, high risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention (M) | Active comparator | Other: Music InterventionThe 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. |
| Muscle Conditioning Intervention (E) | Experimental | Other: Music Intervention, Other: Muscle Conditioning InterventionE (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music InterventionMusic will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed. | Other | Muscle Conditioning Intervention (E), Music Intervention (M) |
| Muscle Conditioning InterventionMusic 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. | Other | Muscle Conditioning Intervention (E) |
Primary outcome
Score on the Functional Mobility Assessment Tool
Time frame: 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).
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle F Mottola, PhD principal investigator
University of Western Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention and Muscle Conditioning Intervention in people with High-Risk Pregnancy, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on the Functional Mobility Assessment Tool (time frame: 2 weeks post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.