Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04859348 |
| Other study ID # |
IRB-UOL-FAHS/600-1/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2020 |
| Est. completion date |
April 16, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of Lahore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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. .
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:
1. Glucose level ………….
2. Delivery:
i) Normal delivery ii) C-Section
3. APGAR Score:
i) 1st min ……………. ii) 5th min …………….
4. Gestational age at birth ………
Outcome variables:
GROUP B (RPT+ Antenatal exercises+ Insulin therapy)
1. Glucose level ………….
2. Delivery:
i) Normal delivery ii) C-Section
3. APGAR Score:
i) 1st min ……………. ii) 5th min ……………. iii)
4. Gestational age at birth………
