Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000809437
Ethics application status
Approved
Date submitted
14/06/2016
Date registered
21/06/2016
Date last updated
23/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilates for low risk pregnant women
Scientific title
Pilates exercises for low-risk pregnant women: A feasibility study
Secondary ID [1] 289433 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
PALP PilAtes Lowrisk Pregnant
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 299116 0
Condition category
Condition code
Reproductive Health and Childbirth 299186 299186 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the Intervention group will be able to commence the Pilates intervention after the successful completion of the initial screening appointment, and during 21 to 25 weeks gestation). Participants in the intervention group will be provided with education on safety recommendations for movement during pregnancy (i.e. back care, changing position from lying in supine) and using the Pilates reformer equipment at their initial Pilates class.

Intervention group: Pilates Exercise
The Pilates intervention will include: one-hour Pilates group classes once per week and daily home exercises over a period of 6 weeks. The Pilates classes will be held at a Physiotherapy and Pilates clinic in Richmond, Melbourne. The Pilates class will be instructed by the student researcher who is a registered nurse/midwife and a certified Polestar(Registered Trademark) Pilates rehabilitation practitioner. The Pilates exercise program will include matwork and reformer equipment exercises incorporating strength-resistant exercises and muscle stretching. The reformer is a bed-like frame with a padded carriage, which moves back and forth on wheels. The carriage is attached to the end of the frame by a set of springs. The choice of springs used varies levels of resistance. An adjustable foot-bar at the end of the reformer can used by feet and hands to push the carriage. On the other end of the reformer, long straps with handles attach the frame to the carriage whereby hands and legs may pull the straps to move the carriage. The reformer allows closed and open chain exercises to be performed, particularly exercises for joint stabilisation and core stabilisation and can be modified to accommodate for an individual’s height and weight.
Participants will have a choice of two Pilates classes to attend. Participants will attend the Pilates class along with privately paying clients, who may be pregnant or in the postnatal period. Each class will instruct a maximum of eight women per class. Eight women per Pilates class is large enough to encourage socialisation and cohesion and small enough to permit adequate supervision during exercise.

Each 1-hour Pilates exercise class will follow the American College of Obstetricians and Gynaecologists’ (2002) recommendations for physical activity during pregnancy. Each class will consist of:
1. A 10-15 minute warm up beginning with thoracic/lateral breathing exercises, followed by gentle exercise to warm up joints and extremities (i.e. arm arcs, slow squat).
2. 30-35 minute of exercises beginning with postural correction and neutral pelvic alignment awareness exercises. This will be followed by exercises targeting lower extremity strength and endurance; upper extremity mobility, strength and endurance; upper and lower extremity weight-bearing; spine mobility; pelvic mobility; abdominal strength and lumbopelvic stability exercises. Pelvic floor contractions and awareness exercises will also be incorporated.
3. The class will conclude with 5-10 minute of breathing, relaxation and awareness exercises with light muscle stretching. Exercise design and repetitions will be documented on a separate form for each client. The exercise design has been evaluated by an expert panel of two physiotherapists and Principal Polestar Pilates educators

Attrition
Attrition will be defined as the proportion of subjects who withdraw from the study prior to the follow-up assessment. Reasons for withdrawal will be collected.

Adherence
Adherence will be measured by recording weekly attendance at the Pilates class and conduct of home exercise.
Adverse events: Risk and management
Outcome measures for adverse events will include musculoskeletal injury and problematic symptoms). Immediately after each Pilates class, the participants will indicate on a questionnaire any injury sustained in the previous week. The participants will also complete a questionnaire about the presence of potentially problematic symptoms including: headache, light-headedness, tightness in the chest, extreme perspiration, vaginal bleeding, calf pain or swelling, abdominal cramping or pain, heart palpitations extreme shortness of breath, dizziness, nausea, vomiting, uterine tightenings /contractions, amniotic fluid leakage and deep severe back or pubic pain.

Home Exercise
Participants will be provided with a Pilates exercise program to be performed daily at home. The participants will be provided with an electronic video recording of the exercise program, saved on a USB stick. Participants will be asked to record their completion of exercises including repetition and comments in their logbooks. A maximum of five Pilates exercises will be instructed.

Participants will be advised to stop exercising if any of the following occurs, and to contact the student researcher:
1. Frontal headache
2. Light-headedness / dizziness
3. Tightness in the chest
4. Extreme perspiration
5. Vaginal bleeding
6. Calf pain or swelling
7. Abdominal cramping or pain
8. Heart palpitations
9. Extreme shortness of breath
10. Nausea
11. Vomiting
12. Uterine tightenings /contractions
13. Amniotic fluid leakage
14. Deep severe back or pubic pain
Intervention code [1] 295025 0
Other interventions
Comparator / control treatment
For this study, routine antenatal care is defined as private obstetric care, which is a model of continuity of care with a specialist obstetrician, whereby a woman attends all her antenatal appointments at the obstetrician’s clinic and receives intrapartum and postnatal care from a private hospital by a team of midwives who work collaboratively with the woman’s obstetrician (NHMRC, 2010). Women in the control group may also attend Pilates or another form of exercise if so recommended by their obstetrician.
Control group
Active

Outcomes
Primary outcome [1] 298618 0
Attrition
Timepoint [1] 298618 0
Attrition will be defined as the proportion of subjects who withdraw from the study prior to the follow-up assessment (completion of 6 weeks of intervention). Reasons for withdrawal will be collected.
Primary outcome [2] 298619 0
Adherence
Timepoint [2] 298619 0
Adherence will be measured by recording weekly attendance at the Pilates classes over 6 weeks. In addition, frequency and duration of daily home exercise over 6 weeks will be recorded by subjects in a log book.
Primary outcome [3] 298620 0
Outcome measures for adverse events will include musculoskeletal injury and potentially problematic symptoms. Outcome measures for adverse events will include musculoskeletal injury and problematic symptoms which has been used in previous study (O'Connor et al.,(2011). Immediately after each Pilates class, the participants will indicate on a questionnaire any injury sustained in the previous week. The participants will also complete a questionnaire about the presence of potentially problematic symptoms including: headache, light-headedness, tightness in the chest, extreme perspiration, vaginal bleeding, calf pain or swelling, abdominal cramping or pain, heart palpitations extreme shortness of breath, dizziness, nausea, vomiting, uterine tightenings /contractions, amniotic fluid leakage and deep severe back or pubic pain. These potential problems have been derived from the recently published American College Obstetrics and Gynecologists recommendations for indications to cease exercise (ACOG, 2015). The questionnaires were designed specifically for the aims of this study.
Timepoint [3] 298620 0
Immediately after each Pilates class for 6 weeks.
Secondary outcome [1] 324771 0
Lower extremity performance
In this study, upper leg tests will be conducted as a measure of lower extremity performance. These will include: 1) Wall Squat test – The participant is supported by the wall and required to maintain the squat position for 30 seconds(Misuk 2013, Goldring, Wiles et al. 2014) 2) Sit to stand test: the participant will be asked to sit down on a chair and stands for 30 seconds. The number of completed ‘sit to stand’ movements will be measured;(Altan, Korkmaz et al. 2009, Kalliokoski, Bergqvist et al. 2013, Kucukcakir, Altan et al. 2013) and 3) Single calf raise test - The participant will face the wall with two hands leaning on the wall for support in a unipedal stance(Hebert-Losier, Newsham-West et al. 2009, Hebert-Losier, Schneiders et al. 2009). The number of heel raises completed in 10 seconds will be measured.
Timepoint [1] 324771 0
This will be conducted 1 week before the commencement of the intervention (Baseline) and one after the completion of the 6 week Pilates intervention (Follow-up)
Secondary outcome [2] 324772 0
Quality of life
The SF-12 instrument is the abridged version of the SF-36 and consists of 12 questions that measure the individual’s perspective of their functional health and wellbeing(Mogos, August et al. 2013) These include physical function (limitations in daily life secondary to health problems); physical role (limitations in role due to physical health problems); bodily pain scale (pain frequency and interference with role); individual health (perspectives of one’s own general health); vitality scale (energy level and fatigue); role emotional (role limitations secondary to emotional problems); and mental health (psychological distress)(Ware, Kosinki et al. 1996, Busija, Pausenberger et al. 2011).
Timepoint [2] 324772 0
This will be conducted 1 week before the commencement of the intervention (Baseline) and one after the completion of the 6 week Pilates intervention (Follow-up)
Secondary outcome [3] 324773 0
Stress urinary incontinence
For the current study, symptoms of stress urinary incontinence and impact on QOL will be measured by the ‘International Consultation on Incontinence Questionnaire’ (ICIQ)(Avery, Donovan et al. 2004), which has been found to be robust for the measurement of continence symptoms and impact on quality of life(Avery, Donovan et al. 2004).
Timepoint [3] 324773 0
This will be conducted 1 week before the commencement of the intervention (Baseline) and one after the completion of the 6 week Pilates intervention (Follow-up).
Secondary outcome [4] 324774 0
Diastasis of rectus abdominis
Participants will be assessed for abdominal muscle separation (diastasis rectus abdominis). The subject’s DRAM assessment will require the subject to be in a crook lying position. The research assistant will face the subject and place the fingertips widthways on the abdomen just above the umbilicus. The subject will have her hands behind her head and will be asked to perform a chest lift. The medial edges of the two rectus abdominis muscles will be palpated and the distances between will be measured in finger-widths. This will be repeated just below the umbilicus with the second chest lift. The length of the separation will be assessed using a centimetre tape measure above and below the umbilicus(Barton 2004). This will be conducted in a private consulting room to maintain privacy of the participant. The research assistant will be a midwife or physiotherapist who has experience in abdominal palpation for muscle separation. Participants will be asked to wear a light t-shirt if they do not wish to expose their abdomen to the student researcher.
Timepoint [4] 324774 0
This will be conducted 1 week before the commencement of the intervention (Baseline) and one after the completion of the 6 week Pilates intervention (Follow-up).
Secondary outcome [5] 324780 0
Mode of birth,
Participants will be asked about their mode of birth (i.e. unassisted vaginal birth, assisted vaginal birth, caesarean section).
Timepoint [5] 324780 0
1-2 week postpartum (post birth)
Secondary outcome [6] 324905 0
Maternal positions
Participants will be asked to provide information about the positions they adopted during labour and birth.
Timepoint [6] 324905 0
1-2 week postpartum (post birth)
Secondary outcome [7] 324906 0
Analgesia used.
Participants will be asked to state the analgesia used during labour and birth (i.e. Nitrous oxide, Pethidine, Morphine, epidural).
Timepoint [7] 324906 0
1-2 weeks postpartum (post birth)
Secondary outcome [8] 324907 0
Duration of labour and birth
Women will be asked about their duration of first stage and second stage labour.
Timepoint [8] 324907 0
1-2 weeks postpartum (post birth)

Eligibility
Key inclusion criteria
1. Women will be recruited between 18 and 25 weeks gestation. At this stage of pregnancy, women will have had an ultrasound examination which identifies normal growth and development of the foetus and the placental position. The intervention can commence from 20 to 25 weeks gestation.
2. Low risk prima gravida women (1st pregnancy).
3. Singleton pregnancy (one fetus). (Multiple pregnancy is associated with complications during pregnancy such as hypertension, diabetes, premature birth).
4. Normal 18-20 week ultrasound. (To confirm risk status of the pregnancy)
5. Booked at Epworth HealthCare or St. Vincent’s Private hospital for maternity care. (Location of hospitals is in close proximity to Pilates clinic, which is also the site for recruitment).
6. Woman reports no current musculoskeletal/joint pain. (To eliminate risk of complications during pregnancy).
7. No previous or current stress urinary incontinence. (To eliminate risk of complications during pregnancy).
8. Women are able to speak and read English.
9. Ambulance cover.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Hyperemesis gravidarum (severe morning sickness).
2. Cardiac disease, including hypertension (high blood pressure).
3. Renal disease.
4. Diabetes requiring insulin medication.
5. Severe depression or anxiety requiring specialist psychiatric treatment
6. Haematological disorders, including thromboembolic disease.
7. Epilepsy requiring pharmacotherapy.
8. Malignant disease (such as cancer).
9. Severe asthma.
10. BMI > 40 or < 18.
11. Addiction to an illicit substance.
12. Previous miscarriage or still-birth.
13. Rhesus isoimmunisation or other significant blood group antibodies.
14. Previous uterine surgery i.e. cone biopsy
15. Previous antenatal haemorrhage.
16, History of extremely sedentary lifestyle.
17. Heavy smoker. (Tobacco smoking is associated with premature labour and fetal intrauterine growth restriction).
18. Abnormal ultrasound (i.e. low lying placenta or placental abnormalities).
19. Non-singleton pregnancy. (Multiple pregnancy is associated with complications during pregnancy such as hypertension, diabetes, premature birth).
20. Physical injury, requiring management by medical team or physiotherapist.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be conducted using an electronic computer program to generate study allocation to intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be conducted using blocked randomization. To protect the investigator and research assistant from predicting the intervention sequence, a large block size will be used. A separate researcher (called the assigner) from a University other than La Trobe University will use a computer generator to randomise participants to treatment or control group. .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics including frequencies, percentages, median, mean and standard deviation will be used to analyse feasibility outcomes. Analysis of comparative data will utilise independent sample t-tests and chi-square tests to determine if there were differences in demographic variables. Repeated measures analysis of variances will be utilised to determine if changes in secondary outcomes occur over time. Statistical analysis will be conducted using SPSS (version 22).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2016
Actual
27/01/2017
Date of last participant enrolment
Anticipated
25/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5973 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 5974 0
Epworth Freemasons - Melbourne
Recruitment postcode(s) [1] 13394 0
3065 - Fitzroy
Recruitment postcode(s) [2] 13395 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 293809 0
University
Name [1] 293809 0
La Trobe University Postgraduate Student Fund
Country [1] 293809 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country
Australia
Secondary sponsor category [1] 292640 0
None
Name [1] 292640 0
Address [1] 292640 0
Country [1] 292640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295241 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 295241 0
Ethics committee country [1] 295241 0
Australia
Date submitted for ethics approval [1] 295241 0
06/04/2016
Approval date [1] 295241 0
19/07/2016
Ethics approval number [1] 295241 0
Conditional approval HREC/16/SVHM/35
Ethics committee name [2] 295242 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 295242 0
Ethics committee country [2] 295242 0
Australia
Date submitted for ethics approval [2] 295242 0
30/06/2016
Approval date [2] 295242 0
18/08/2016
Ethics approval number [2] 295242 0
A site specific form will be completed once approval has been gained from St Vincent's HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66658 0
Prof Meg E Morris
Address 66658 0
La Trobe University, College of Science, Health and Engineering
School of Allied Health Plenty Road & Kingsbury Drive, Melbourne VIC 3086
Country 66658 0
Australia
Phone 66658 0
+61 03 9479 6080
Fax 66658 0
Email 66658 0
[email protected]
Contact person for public queries
Name 66659 0
Melissa Mazzarino
Address 66659 0
Victoria University, College of Health and Biomedicine, McKechnie St, St Albans, 3021, Melbourne, Victoria, Australia
Country 66659 0
Australia
Phone 66659 0
+61 03 99192024
Fax 66659 0
Email 66659 0
[email protected]
Contact person for scientific queries
Name 66660 0
Melissa Mazzarino
Address 66660 0
Victoria University, College of Health and Biomedicine, McKechnie St, St Albans, 3021, Melbourne, Victoria, Australia
Country 66660 0
Australia
Phone 66660 0
+61 03 99192024
Fax 66660 0
Email 66660 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePilates for low risk pregnant women: Study protocol for a randomized controlled trial.2021https://dx.doi.org/10.1016/j.jbmt.2020.12.015
N.B. These documents automatically identified may not have been verified by the study sponsor.