Gestational DiabetesNCT04859348
Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus
A study testing routine physical therapy and routine physical therapy and antenatal exercises in people with Gestational Diabetes, run by University of Lahore at 1 site in Pakistan.
Trial summary
Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy. Objectives was to determine the effects of Antenatal exercises on glucose levels, mode of delivery and APGAR Score in females with gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- routine physical therapy and routine physical therapy and antenatal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 16 Apr 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Panel patients who are covered under medical facility provided by the company
- Booked cases
- Participant's Borg scale score 6 to 14
- Age 20-35 years
- 20-24 weeks of gestation
- Diagnosed case of GDM
- Primigravida
- BMI does not exceed 40 kg/m²
Who cannot join
- Females diagnosed with vascular complications (Preeclampsia, hemolysis etc.)
- Uncontrolled diabetes mellitus
- Autonomic dysfunction /Peripheral neuropathy (Damage to the nerves outside of the brain and spinal cord which effect sensations)
- Nephropathy or retinopathy (Damage to the small blood vessels of kidneys and eyes)
- Twins fetus
- Placenta Previa (placenta partially or totally covers the mother's cervix)
Show all 11Show fewer
- Fetal anomalies
- Female choice for caesarean section
- Intrauterine growth retardation (fetal complication)
- Short cervix length
- Antepartum hemorrhage (bleeding from the genital tract)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus: a Randomized Controlled Trial
Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy. Objectives was to determine the effects of Antenatal exercises on glucose levels, mode of delivery and APGAR Score in females with gestational diabetes mellitus.
This Randomized controlled trial study was conducted on N= 72 pregnant females at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore after Ethical approval of synopsis from institutional Review Board of the University of Lahore . The data was entered and analyzed using SPSS Version 24. .
Read the detailed description
Gestational diabetes mellitus (GDM) is defined as glucose intolerance resulting in hyperglycemia of variable severity with onset during pregnancy. During pregnancy, GDM is the most common complication occurs and it affects the health of the child and mother.
This study aim was to investigate the effect of antenatal exercise on clinical outcomes in pregnant females with gestational diabetes mellitus.
Study Design: Randomized controlled trial. Settings: It was conducted at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore.
Sample Size:
The calculated sample size is 30 in each group using APGAR scale as outcome measure. After adding 20% drop out the sample size will become 30+6 = 36 in each group.
Sampling Technique: Purposive sampling technique
Outcome measuring Tools -
- APGAR scale DATA COLLECTION PROCEDURE
All the participants visited from the gynecology department after the diagnosis of GDM was considered after the initial screening test. Following the inclusion and exclusion criteria before adding them to the study. These patients were allotted in two groups i.e. group A and group B via the lottery method. Informed consent were taken in written form showing that they are willing to participate in the study. The therapist had assessed the patients before the start of rehabilitation program:
Group A includes participants received the routine physical therapy only. Group B includes participants were given exercise program from 20- 24 weeks of gestation to till the date of delivery, with addition of the routine physical therapy plan.
Group A: Routine Physical Therapy (RPT) + Insulin therapy Group A- (n=36) participants received only routine treatment for gestational diabetes mellitus which includes insulin therapy and diet control programs guided by a gynecologist and routine physical therapy which includes walk for 1 hr which includes proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery.
Group -B-Antenatal + RPT + Insulin therapy+ Exercise Group B- (n=36) participants completed routine therapy and antenatal exercises which includes Aerobic and strengthening Exercises with workout 3 days a week, for 2 weeks (6 sessions under the supervision of physiotherapist and remaining was performed at home along with routine treatment for gestational diabetes mellitus which includes insulin therapy and diet control program as guided by gynecologist. The exercise program was started with quarter-hour moderate-intensity aerobic activity and slowly rising the duration to a maximum of half-hour each exercise session. A 10-15-minute warm-up physical exercise, and a 10-15-minute cool-down period was included. The duration of the exercise was assessed by using target pulse rate, the Borg scale (rate of perceived exertion), or the 'talk test.' American College of Obstetricians and Gynecologists Guideline corresponded to exercise of moderate-intensity were followed. Aerobic exercise includes a brisk walk to train the main muscle groups which includes, chest muscles, deltoid, quadriceps, and calf muscles were targeted the main muscle groups .In sitting position, strengthening exercise were performed in which one end of the Thera band was placed under the foot, hold for 5 seconds then released along with 10 repetitions. The movements were involvement of wall push-ups, shoulder flexion, shoulder abduction, knee extension and ankle plantar flexion. It was guided that pregnant women avoid exercise promptly if they experience any signs such as dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Besides, group participant will wear loose-fitting clothing and keep hydrated while exercising in an environment with adequate temperature and moisture. All sessions of the exercise under supervision were fully documented on successful completion.
Confidentiality of all the details were ensured. A blind study (to remove chance of bias), in which random allocation of women between two categories, via the lottery system was executed.
Follow Ups Total 3 sessions per week were given to the patients for 60 min., from 20- 24 weeks of gestation to till the time of delivery. Home plan was given to the participants and follow up was done whenever participants came to gynecology department.
PROFORMA/QUESTIONNAIRE
Title "Effects of Antenatal exercises on clinical outcomes in pregnant females with gestational diabetes mellitus: A Randomized Controlled Trial" Name………………... Age …………………. Height ………………. Weight ………………… Phone no …………………. Gestation age …………… Borg scale ……………. BMI ………………. Evaluation Sheet
Group A (RPT+ Insulin therapy)
Outcome variables:
- Glucose level ………….
- Delivery:
- Normal delivery ii) C-Section
- APGAR Score:
- 1st min ……………. ii) 5th min …………….
- Gestational age at birth ………
Outcome variables:
GROUP B (RPT+ Antenatal exercises+ Insulin therapy)
- Glucose level ………….
- Delivery:
- Normal delivery ii) C-Section
- APGAR Score:
- 1st min ……………. ii) 5th min ……………. iii)
- Gestational age at birth………
- Conditions
- Gestational Diabetes
- Being tested
- routine physical therapy, routine physical therapy and antenatal exercises
- Keywords
- Antenatal Exercise, APGAR Score, C-section, Mode of delivery, Pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine physical therapyOther
G- A 36 participants received only routine treatment for GDM which includes insulin therapy and diet control guided by gynecologist and routine physical therapy which includes walk for 1 hr with proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery.
routine physical therapy and antenatal exercisesOther
G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises for 3 days a week, for 2 weeks 6 sessions under the supervision of physiotherapist and remaining was performed at home. Exercise was started from 15 min and reach to 30 mins gradually.10-15-minute warm-up, cool-down period was included by using ACOG Guideline. Aerobic exercise includes a brisk walk and strengthening exercise were performed with hold for 5 seconds and 10 repetitions. Exercise should stop if they experience any signs of dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Confidentiality and blindness ensure by random allocation.
| Study group | Role | What they receive |
|---|---|---|
| Group-A ( RPT+ Insulin Therapy) | Experimental | Group A includes participants received the routine physical therapy only. Receives: Other: routine physical therapy |
| Group-B (RPT+ Antenatal Exercises+ Insulin therapy) | Experimental | Group B includes participants were given antenatal exercise program from 20- 24 weeks of gestation to till the date of delivery, with addition of the routine physical therapy plan. Receives: Other: routine physical therapy and antenatal exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose level
Effect of antenatal exercise on glucose level was measured by test beta HbAc1 performed by gynecology department before delivery
Measured: 4 months
mode of delivery
effect of antenatal exercise on type of delivery was studied as it was normal vaginal or caesarian section
Measured: 4 months
APGAR Score
effect of antenatal exercise on APGAR score was studied which describe fetal health after delivery
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Nov 2020
- Primary completion1 Mar 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Model description
- G- A 36 participants received only routine treatment for GDM G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anum Sattar, MPhil, Principal investigator, student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859348
- Sponsor's protocol ID
- IRB-UOL-FAHS/600-1/2020
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected data will be share.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Exercises on Clinical Outcomes in Pregnant Females With Gestational Diabetes Mellitus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04859348
- Acronym / sponsor ID
- IRB-UOL-FAHS/600-1/2020
- Conditions
- Gestational Diabetes
- Keywords
- Antenatal Exercise, APGAR Score, C-section, Mode of delivery, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 26 Apr 2021 (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.
Gestational diabetes mellitus (GDM) GDM is the most common complication that affects the health of the child and mother during pregnancy. Objectives was to determine the effects of Antenatal exercises on glucose levels, mode of delivery and APGAR Score in females with gestational diabetes mellitus.
This Randomized controlled trial study was conducted on N= 72 pregnant females at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore after Ethical approval of synopsis from institutional Review Board of the University of Lahore . The data was entered and analyzed using SPSS Version 24. .
Detailed description
Gestational diabetes mellitus (GDM) is defined as glucose intolerance resulting in hyperglycemia of variable severity with onset during pregnancy. During pregnancy, GDM is the most common complication occurs and it affects the health of the child and mother.
This study aim was to investigate the effect of antenatal exercise on clinical outcomes in pregnant females with gestational diabetes mellitus.
Study Design: Randomized controlled trial. Settings: It was conducted at department of Gynecology and Obstetrics, Mian Munshi DHQ Hospital, Lahore.
Sample Size:
The calculated sample size is 30 in each group using APGAR scale as outcome measure. After adding 20% drop out the sample size will become 30+6 = 36 in each group.
Sampling Technique: Purposive sampling technique
Outcome measuring Tools -
- APGAR scale DATA COLLECTION PROCEDURE
All the participants visited from the gynecology department after the diagnosis of GDM was considered after the initial screening test. Following the inclusion and exclusion criteria before adding them to the study. These patients were allotted in two groups i.e. group A and group B via the lottery method. Informed consent were taken in written form showing that they are willing to participate in the study. The therapist had assessed the patients before the start of rehabilitation program:
Group A includes participants received the routine physical therapy only. Group B includes participants were given exercise program from 20- 24 weeks of gestation to till the date of delivery, with addition of the routine physical therapy plan.
Group A: Routine Physical Therapy (RPT) + Insulin therapy Group A- (n=36) participants received only routine treatment for gestational diabetes mellitus which includes insulin therapy and diet control programs guided by a gynecologist and routine physical therapy which includes walk for 1 hr which includes proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery.
Group -B-Antenatal + RPT + Insulin therapy+ Exercise Group B- (n=36) participants completed routine therapy and antenatal exercises which includes Aerobic and strengthening Exercises with workout 3 days a week, for 2 weeks (6 sessions under the supervision of physiotherapist and remaining was performed at home along with routine treatment for gestational diabetes mellitus which includes insulin therapy and diet control program as guided by gynecologist. The exercise program was started with quarter-hour moderate-intensity aerobic activity and slowly rising the duration to a maximum of half-hour each exercise session. A 10-15-minute warm-up physical exercise, and a 10-15-minute cool-down period was included. The duration of the exercise was assessed by using target pulse rate, the Borg scale (rate of perceived exertion), or the 'talk test.' American College of Obstetricians and Gynecologists Guideline corresponded to exercise of moderate-intensity were followed. Aerobic exercise includes a brisk walk to train the main muscle groups which includes, chest muscles, deltoid, quadriceps, and calf muscles were targeted the main muscle groups .In sitting position, strengthening exercise were performed in which one end of the Thera band was placed under the foot, hold for 5 seconds then released along with 10 repetitions. The movements were involvement of wall push-ups, shoulder flexion, shoulder abduction, knee extension and ankle plantar flexion. It was guided that pregnant women avoid exercise promptly if they experience any signs such as dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Besides, group participant will wear loose-fitting clothing and keep hydrated while exercising in an environment with adequate temperature and moisture. All sessions of the exercise under supervision were fully documented on successful completion.
Confidentiality of all the details were ensured. A blind study (to remove chance of bias), in which random allocation of women between two categories, via the lottery system was executed.
Follow Ups Total 3 sessions per week were given to the patients for 60 min., from 20- 24 weeks of gestation to till the time of delivery. Home plan was given to the participants and follow up was done whenever participants came to gynecology department.
PROFORMA/QUESTIONNAIRE
Title "Effects of Antenatal exercises on clinical outcomes in pregnant females with gestational diabetes mellitus: A Randomized Controlled Trial" Name………………... Age …………………. Height ………………. Weight ………………… Phone no …………………. Gestation age …………… Borg scale ……………. BMI ………………. Evaluation Sheet
Group A (RPT+ Insulin therapy)
Outcome variables:
- Glucose level ………….
- Delivery:
- Normal delivery ii) C-Section
- APGAR Score:
- 1st min ……………. ii) 5th min …………….
- Gestational age at birth ………
Outcome variables:
GROUP B (RPT+ Antenatal exercises+ Insulin therapy)
- Glucose level ………….
- Delivery:
- Normal delivery ii) C-Section
- APGAR Score:
- 1st min ……………. ii) 5th min ……………. iii)
- Gestational age at birth………
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- G- A 36 participants received only routine treatment for GDM G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises.
| Arm | Type | Receives |
|---|---|---|
| Group-A ( RPT+ Insulin Therapy) | Experimental | Other: routine physical therapyGroup A includes participants received the routine physical therapy only. |
| Group-B (RPT+ Antenatal Exercises+ Insulin therapy) | Experimental | Other: routine physical therapy and antenatal exercisesGroup B includes participants were given antenatal exercise program from 20- 24 weeks of gestation to till the date of delivery, with addition of the routine physical therapy plan. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Panel patients who are covered under medical facility provided by the company
- Booked cases
- Participant's Borg scale score 6 to 14
- Age 20-35 years
- 20-24 weeks of gestation
Key exclusion criteria (11 listed)
- Females diagnosed with vascular complications (Preeclampsia, hemolysis etc.)
- Uncontrolled diabetes mellitus
- Autonomic dysfunction /Peripheral neuropathy (Damage to the nerves outside of the brain and spinal cord which effect sensations)
- Nephropathy or retinopathy (Damage to the small blood vessels of kidneys and eyes)
- Twins fetus
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 |
|---|---|---|
| routine physical therapyG- A 36 participants received only routine treatment for GDM which includes insulin therapy and diet control guided by gynecologist and routine physical therapy which includes walk for 1 hr with proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery. | Other | Group-A ( RPT+ Insulin Therapy) |
| routine physical therapy and antenatal exercisesG- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises for 3 days a week, for 2 weeks 6 sessions under the supervision of physiotherapist and remaining was performed at home. Exercise was started from 15 min and reach to 30 mins gradually.10-15-minute warm-up, cool-down period was included by using ACOG Guideline. Aerobic exercise includes a brisk walk and strengthening exercise were performed with hold for 5 seconds and 10 repetitions. Exercise should stop if they experience any signs of dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Confidentiality and blindness ensure by random allocation. | Other | Group-B (RPT+ Antenatal Exercises+ Insulin therapy) |
Primary outcome
Glucose level
Time frame: 4 months
Effect of antenatal exercise on glucose level was measured by test beta HbAc1 performed by gynecology department before delivery
mode of delivery
Time frame: 4 months
effect of antenatal exercise on type of delivery was studied as it was normal vaginal or caesarian section
APGAR Score
Time frame: 4 months
effect of antenatal exercise on APGAR score was studied which describe fetal health after delivery
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 26 Apr 2021.
- Individual participant dataSharing planned: Yes. all collected data will be share.
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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.
Anum Sattar, MPhil principal investigator
student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine physical therapy and routine physical therapy and antenatal exercises in people with Gestational Diabetes, run by University of Lahore at 1 site in Pakistan.
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 8 inclusion and 11 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 26 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 Pakistan. 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?
Glucose level (time frame: 4 months). The study lists 3 primary outcomes in all. 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 26 Apr 2021.