PostpartumNCT03405649
Active Mother May Lead to an Active Baby.
A study testing Group A and Group B in people with Postpartum and Exercise, run by Western University, Canada at 1 site in Canada.
Trial summary
Among the well-known factors that contribute to the development of obesity, childbearing has been reported as an important influential factor. Physical activity is strongly recommended as one of the main tools to reduce any excessive weight gain during pregnancy and also to reduce weight retention in the postpartum… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Exercise, Intervention
- What is being tested?
- Group A and Group B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 2 Aug 2018to 1 Jan 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy (free from chronic diseases) women between 8 weeks and 50 weeks after delivery.
Who cannot join
- Inability to perform strength training or moderate-intensity exercise, athletes/well trained mothers (i.e. mothers undergoing regular strength training), smokers and women who are planning to become pregnant over the subsequent year. Women who cannot read, write and understand English will not be included.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario
London, Ontario, N6A 3K7
About this study
Official title: Active Mother- Active Baby: Resistance Training in Postpartum Women as a Group Class Exercise Intervention With Their Babies.
Among the well-known factors that contribute to the development of obesity, childbearing has been reported as an important influential factor. Physical activity is strongly recommended as one of the main tools to reduce any excessive weight gain during pregnancy and also to reduce weight retention in the postpartum period. During the postpartum period, exercise training coupled with a well-balanced nutritional plan, offers an effective intervention to help mothers lose weight safely. International guidelines for physical activity after pregnancy include strengthening routines. Worth noting, most of the above cited studies focused on the benefits of aerobic activities. Strength training interventions are virtually unexplored in postpartum women despite its potential benefits. Compared to the pregnancy period, postpartum barriers to physical activity seem to focus less on health-related barriers. In postpartum, time limitations for childcare become a more common barrier. For this reason, a postpartum exercise program that incorporates the babies in a specific exercise session has a better chance to succeed. The aim of this project is to determine the benefits of strength training in a group class setting in postpartum healthy women with their babies. Whereas mother's participation in regular physical activity may encourage regular physical activity habits in her offspring, a second aim of this project is to also quantify the infant's physical activity. The main measured outcomes are: maternal muscular strength; body composition; aerobic capacity; exercise self efficacy; depressive symptoms; physical activity level and food habits and baby's physical activity level.
Read the detailed description
Research Questions:
Maternal:
Is a strength training group class (with babies) in postpartum women associated with (I) strength and lean body mass improvement, (II) improvement aerobic capacity, (III) more spontaneous physical activity, (IV) better self efficacy and (V) better mood?
Baby:
Does maternal lifestyle affect the baby's (0-12 months) physical activity level?
Hypothesis:
It is hypothesized that women who complete the 10 week exercise program will have improved strength from pre-intervention to post intervention. It is also hypothesized that women who are adherent to the exercise program will have more active babies.
Methods:
Participants train 60 min per session for 10 weeks on non consecutive days (Tues and Thurs). All training sessions will be supervised by a qualified exercise instructor (graduate in kinesiology) to ensure proper technique and to minimize the risk of injury. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. The strength training protocol is based on the American College of Sports Medicine (ACSM) guidelines. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies will also be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. The principle of progressive overload will follow a linear increase as described in ACSM position stand.
All participants will be tested at time points t0 , t1 ( after 5 weeks) and t2 (after 10 weeks; at the and of the study) on: i) strength and body composition; ii) aerobic capacity; iii) objective and subjective physical activity level; vi) exercise self efficacy; v) depressive symptoms and vi) dietary habits.
- Strength/Body composition assessment At each time point, strength will be assessed for the upper body (push-ups), lower body (squats), and trunk (abdominal curl-up test). The participants will perform push-ups (as many as possible using a fixed pattern of 40 beats per minute - time and number will be recorded up to a maximum of 1 minute). This will be repeated for the number of lower body squat position performed (as many squats as possible using a fixed pattern of 40 beats per minute -time and number will be recorded up to a maximum of 1 minute); these methods have been chosen to reduce the likelihood of any adverse events. The participant will also complete the ACSM-recommended partial curl-up test to assess abdominal strength and endurance. Briefly, as many abdominal curl-ups as possible has to be performed until the participant either stops, or cannot stay in rhythm with a fixed cadence (40 beats/min) up to 1 minute as per ACSM guidelines.
Body composition assessment will include body mass, height, BMI and body fat (sum of five skinfolds: triceps, biceps, subscapular, suprailiac, thigh) measures.
II. Aerobic capacity Briefly, participants perform a 5- min. bout of exercise, stepping up and down from a standard step (height 30 cm) following a specific cadence. During the step test, heart rate (HR) is measured continuously using a heart-rate monitor. Then, VO2max is estimated based on HR and a target exercise intensity (estimated VO2).
III. Physical activity assessment At each time point, participants will to complete two self- reported questionnaires regarding physical activity level, the International Physical Activity Questionnaire (IPAQ; and the Physical Activity Readiness Questionnaire (PAR-Q+).The IPAQ asks participants to recall their levels of physical activity within five domains (leisure, work, transportation, household, recreation) and three intensity categories over a 7-day recall period. The PAR-Q+ determines if it is safe to start an exercise program. Additionally, at t0, t1 and t2 each participant will complete an individual physical activity diary for 7 days. Moreover, during this period participants will continuously wear a pedometer .
IV. Exercise self efficacy Exercise self-efficacy will be measured at each time point (t0,t1 and t2). This survey includes five separate items targeting self-efficacy.
- Depressive symptoms Levels of postpartum mood will be assessed through the Edinburgh Postnatal Depression Scale (EPDS).
VI. Eating Habits Mother's eating habits will be measured through the Short-Form Frequency Questionnaire (SFFFQ).
VII. Breastfeeding habits will be measured through a Breastfeeding and Infant Feeding Questionnaire.
Baby At each time point, a Rothbart Infant Behavior Questionnaire- Revised (IBQ-R) will be completed by the participants to measure temperament and gross motor activity in infants between the ages of 3 and 12 months.
This study will take place at the Canadian Centre for Activity and Aging gymnasium on Tuesday and Thursday afternoons (time to be determined). Women who contact us will be asked when their baby was born. Those women whose babies are less than 20 weeks of age will be placed in Group A and those women whose babies are older than 20 weeks will be placed in Group B. These groups were divided by baby age because early postpartum women and babies are a different group than those women with babies 6 months and older.
- Conditions
- Postpartum, Exercise, Intervention
- Being tested
- Group A, Group B
- Keywords
- postpartum, exercise, intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABehavioural
Muscle conditioning exercise for postpartum women and infants less than 20 weeks of age.
Group BBehavioural
Muscle conditioning exercise for postpartum women and infants more than 20 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants train 60 min per session for 10 weeks on non-consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and weights, elastic bands and balls will be used. Babies less than 20 weeks of age will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. Receives: Behavioral: Group A |
| Group B | Experimental | Participants train 60 min per session for 10 weeks on non consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies older than 20 weeks will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. Receives: Behavioral: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal overall muscular strength
A series of muscular strength assessments will be performed at baseline, after 5 weeks and at 10 weeks of intervention. Higher number of timed push-ups, squats and sit-ups increased from baseline will indicate improved muscular strength.
Measured: 10 weeks
Secondary outcomes (7)
Maternal body composition
Maternal skinfolds will be assessed at baseline, after 5 weeks and at 10 weeks of intervention. Decreased skinfold measurements from baseline will indicate improved body composition and loss of body fat.
Measured: 10 weeks
Maternal aerobic capacity
Maternal oxygen consumption will be measured at baseline, after 5 weeks and at 10 weeks of intervention. Improvement in aerobic capacity will be indicated by higher estimated VO2 measurements at the end of the intervention compared to baseline.
Measured: 10 weeks
Maternal physical activity level measured by the International Physical Activity Questionnaire (IPAQ)
Using the IPAQ, physical activity will be measured at baseline, after 5 weeks and at 10 weeks of intervention. Based on the IPAQ vigorous activity is 8 METmin/day; moderate activity is 4 METmin/day and light activity is 3 METmin/day. Total activity will be the addition of vigorous, moderate and light activities recorded in METmin/day. Total METmin/day that is <700 is defined as "inactive"; 700-2519 METmin/day is defined as "active" and > 2520 METmin/day is defined as "very active". An increase in physical activity will be indicated by an increase in total METmin/day from baseline to end of intervention.
Measured: 10 weeks
Maternal self-efficacy
Women will complete a self-efficacy questionnaire at baseline, after 5 weeks and at 10 weeks at the end of the intervention. Improvement in self-efficacy will be indicated by an increase in total score from baseline.
Measured: 10 weeks
Maternal eating habits
Women will complete a food frequency questionnaire at baseline, after 5 weeks and at 10 weeks at the end of the intervention. Dietary habits will be improved from baseline if women eat more healthy foods such as vegetables and fruit and decrease intake of high density foods such as junk food.
Measured: 10 weeks
Maternal breast feeding behavior
Women will complete a breast feeding questionnaire at baseline, after 5 weeks and at 10 weeks at the end of the intervention. This questionnaire includes frequency of breast feeding and whether infant feeding is supplemented by formula. This is self-reported and descriptive to describe breast feeding behavior.
Measured: 10 weeks
Gross motor activity using the Rothbart Infant Behavior Questionnaire- Revised (IBQ-R)
Women will complete only the activity component of the Rothbart Infant Behavior Questionnaire- Revised (IBQ-R) that contains 15 items to assess infant gross motor activity at baseline, after 5 weeks and at 10 weeks at the end of the intervention. Each question is answered using a 7 point scale (indicating activity over the last 7 days). The scare ranges from 1 - "never", 2 - "very rarely", 3 - "< half the time", 4 - "about half the time", 5 - "> half the time", 6 - "almost always", 7 - "always". The score for the 15 questions is totaled. The higher the score, the more active the infant in gross motor activity. A perfect score is 105 and at each time point the total activity scores will be compared.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 Aug 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Women contacting the lab will be divided into those women who have babies less than 20 weeks of age (Group A) and those whose babies are greater than 20 weeks of age (Group B). Each of these groups will be given a separate postpartum exercise program that will run concurrently. These groups were divided by baby age because we felt early postpartum women and babies are a different group than those women with babies 6 months and older.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Mottola, Western University, Canada
- Investigators
- Michelle F Mottola, PhD, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405649
- Sponsor's protocol ID
- 110303
- Status last verified
- Apr 2021
- First submitted
- 5 Jan 2018
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Mother- Active Baby: Resistance Training in Postpartum Women as a Group Class Exercise Intervention With Their Babies.
- ClinicalTrials.gov ID
- NCT03405649
- Acronym / sponsor ID
- 110303
- Conditions
- Postpartum, Exercise, Intervention
- Keywords
- postpartum, exercise, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
Among the well-known factors that contribute to the development of obesity, childbearing has been reported as an important influential factor. Physical activity is strongly recommended as one of the main tools to reduce any excessive weight gain during pregnancy and also to reduce weight retention in the postpartum period. During the postpartum period, exercise training coupled with a well-balanced nutritional plan, offers an effective intervention to help mothers lose weight safely. International guidelines for physical activity after pregnancy include strengthening routines. Worth noting, most of the above cited studies focused on the benefits of aerobic activities. Strength training interventions are virtually unexplored in postpartum women despite its potential benefits. Compared to the pregnancy period, postpartum barriers to physical activity seem to focus less on health-related barriers. In postpartum, time limitations for childcare become a more common barrier. For this reason, a postpartum exercise program that incorporates the babies in a specific exercise session has a better chance to succeed. The aim of this project is to determine the benefits of strength training in a group class setting in postpartum healthy women with their babies. Whereas mother's participation in regular physical activity may encourage regular physical activity habits in her offspring, a second aim of this project is to also quantify the infant's physical activity. The main measured outcomes are: maternal muscular strength; body composition; aerobic capacity; exercise self efficacy; depressive symptoms; physical activity level and food habits and baby's physical activity level.
Detailed description
Research Questions:
Maternal:
Is a strength training group class (with babies) in postpartum women associated with (I) strength and lean body mass improvement, (II) improvement aerobic capacity, (III) more spontaneous physical activity, (IV) better self efficacy and (V) better mood?
Baby:
Does maternal lifestyle affect the baby's (0-12 months) physical activity level?
Hypothesis:
It is hypothesized that women who complete the 10 week exercise program will have improved strength from pre-intervention to post intervention. It is also hypothesized that women who are adherent to the exercise program will have more active babies.
Methods:
Participants train 60 min per session for 10 weeks on non consecutive days (Tues and Thurs). All training sessions will be supervised by a qualified exercise instructor (graduate in kinesiology) to ensure proper technique and to minimize the risk of injury. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. The strength training protocol is based on the American College of Sports Medicine (ACSM) guidelines. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies will also be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. The principle of progressive overload will follow a linear increase as described in ACSM position stand.
All participants will be tested at time points t0 , t1 ( after 5 weeks) and t2 (after 10 weeks; at the and of the study) on: i) strength and body composition; ii) aerobic capacity; iii) objective and subjective physical activity level; vi) exercise self efficacy; v) depressive symptoms and vi) dietary habits.
- Strength/Body composition assessment At each time point, strength will be assessed for the upper body (push-ups), lower body (squats), and trunk (abdominal curl-up test). The participants will perform push-ups (as many as possible using a fixed pattern of 40 beats per minute - time and number will be recorded up to a maximum of 1 minute). This will be repeated for the number of lower body squat position performed (as many squats as possible using a fixed pattern of 40 beats per minute -time and number will be recorded up to a maximum of 1 minute); these methods have been chosen to reduce the likelihood of any adverse events. The participant will also complete the ACSM-recommended partial curl-up test to assess abdominal strength and endurance. Briefly, as many abdominal curl-ups as possible has to be performed until the participant either stops, or cannot stay in rhythm with a fixed cadence (40 beats/min) up to 1 minute as per ACSM guidelines.
Body composition assessment will include body mass, height, BMI and body fat (sum of five skinfolds: triceps, biceps, subscapular, suprailiac, thigh) measures.
II. Aerobic capacity Briefly, participants perform a 5- min. bout of exercise, stepping up and down from a standard step (height 30 cm) following a specific cadence. During the step test, heart rate (HR) is measured continuously using a heart-rate monitor. Then, VO2max is estimated based on HR and a target exercise intensity (estimated VO2).
III. Physical activity assessment At each time point, participants will to complete two self- reported questionnaires regarding physical activity level, the International Physical Activity Questionnaire (IPAQ; and the Physical Activity Readiness Questionnaire (PAR-Q+).The IPAQ asks participants to recall their levels of physical activity within five domains (leisure, work, transportation, household, recreation) and three intensity categories over a 7-day recall period. The PAR-Q+ determines if it is safe to start an exercise program. Additionally, at t0, t1 and t2 each participant will complete an individual physical activity diary for 7 days. Moreover, during this period participants will continuously wear a pedometer .
IV. Exercise self efficacy Exercise self-efficacy will be measured at each time point (t0,t1 and t2). This survey includes five separate items targeting self-efficacy.
- Depressive symptoms Levels of postpartum mood will be assessed through the Edinburgh Postnatal Depression Scale (EPDS).
VI. Eating Habits Mother's eating habits will be measured through the Short-Form Frequency Questionnaire (SFFFQ).
VII. Breastfeeding habits will be measured through a Breastfeeding and Infant Feeding Questionnaire.
Baby At each time point, a Rothbart Infant Behavior Questionnaire- Revised (IBQ-R) will be completed by the participants to measure temperament and gross motor activity in infants between the ages of 3 and 12 months.
This study will take place at the Canadian Centre for Activity and Aging gymnasium on Tuesday and Thursday afternoons (time to be determined). Women who contact us will be asked when their baby was born. Those women whose babies are less than 20 weeks of age will be placed in Group A and those women whose babies are older than 20 weeks will be placed in Group B. These groups were divided by baby age because early postpartum women and babies are a different group than those women with babies 6 months and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women contacting the lab will be divided into those women who have babies less than 20 weeks of age (Group A) and those whose babies are greater than 20 weeks of age (Group B). Each of these groups will be given a separate postpartum exercise program that will run concurrently. These groups were divided by baby age because we felt early postpartum women and babies are a different group than those women with babies 6 months and older.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Group AParticipants train 60 min per session for 10 weeks on non-consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and weights, elastic bands and balls will be used. Babies less than 20 weeks of age will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. |
| Group B | Experimental | Behavioral: Group BParticipants train 60 min per session for 10 weeks on non consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies older than 20 weeks will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy (free from chronic diseases) women between 8 weeks and 50 weeks after delivery.
Key exclusion criteria (1 listed)
- Inability to perform strength training or moderate-intensity exercise, athletes/well trained mothers (i.e. mothers undergoing regular strength training), smokers and women who are planning to become pregnant over the subsequent year. Women who cannot read, write and understand English will not be included.
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 |
|---|---|---|
| Group AMuscle conditioning exercise for postpartum women and infants less than 20 weeks of age. | Behavioural | Group A |
| Group BMuscle conditioning exercise for postpartum women and infants more than 20 weeks of age. | Behavioural | Group B |
Primary outcome
Maternal overall muscular strength
Time frame: 10 weeks
A series of muscular strength assessments will be performed at baseline, after 5 weeks and at 10 weeks of intervention. Higher number of timed push-ups, squats and sit-ups increased from baseline will indicate improved muscular strength.
7 secondary outcomes
Maternal body composition
Time frame: 10 weeks
Maternal aerobic capacity
Time frame: 10 weeks
Maternal physical activity level measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: 10 weeks
Maternal self-efficacy
Time frame: 10 weeks
Maternal eating habits
Time frame: 10 weeks
Maternal breast feeding behavior
Time frame: 10 weeks
Gross motor activity using the Rothbart Infant Behavior Questionnaire- Revised (IBQ-R)
Time frame: 10 weeks
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 6 Apr 2021.
- Individual participant dataSharing planned: Yes. De-identified participant data for primary and secondary outcome measures will be made available.
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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 Group A and Group B in people with Postpartum and Exercise, 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 1 inclusion and 1 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 6 Apr 2021. 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?
Maternal overall muscular strength (time frame: 10 weeks). 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 6 Apr 2021.