Home » Trials » SLCTR/2025/021
Effectiveness of aerobic exercises on stress level, sleep quality and cardiovascular fitness on pregnant women.
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SLCTR Registration Number
SLCTR/2025/021
Date of Registration
The date of last modification
Jun 05, 2025
Scientific Title of Trial
Effectiveness of aerobic exercises on stress level, sleep quality and cardiovascular fitness on pregnant women.
Public Title of Trial
Effectiveness of an aerobic exercise programme compared to routine maternal care on stress level, sleep quality and cardiovascular fitness among pregnant women.
Disease or Health Condition(s) Studied
Pregnancy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1319-8902
Any other number(s) assigned to the trial and issuing authority
2024/EC/48- ERC
What is the research question being addressed?
Is aerobic exercises effective in improving stress level, sleep quality and cardiovascular fitness among pregnant women compared to routine maternal care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
Study setting- Medical Officer of health (MOH) ,Ragama
Randomization- Simple random sampling:
The pregnant mothers registered under MOH-Ragama for their antenatal clinic who consent to participate in the study and satisfy inclusion criteria will be identified and prepare a list according to the alphabetic order. Of these mothers, 70 number of subjects will be selected by random sampling by randomization on SPSS. The selected participants(70) will be randomly allocated either to the control group(35) and to the treatment group(35) using a computer-based random number generation randomization procedure.
The intervention group will be receiving a 8 weeks Aerobic exercise program and routine antenatal care at MOH Ragama.
The control group will be receiving only routine antenatal care for 8 weeks at MOH Ragama. Blinding- Single blinded, Only outcome assessors are blinded.
The intervention group of pregnant women will be given a home aerobic exercise programme. Exercise programme was designed strictly adhered to ACSM guidelines for pregnant women. On the 1st day participants will be asked to come with their husband or family member. Full aerobic exercise steps including 5 minutes warm up, 30 minutes aerobic exercise, 5 minutes cool down will be demonstrated and taught properly for each participant. The exercise programme will be demonstrated by the researcher and the participants will be requested to perform the exercises steps and any deviations will be corrected. They will be instructed to carry out the moderate intensity exercise programme for 8 weeks with a frequency of 4 days per week. Intensity of the exercises will be assessed using Borg scale. In addition, a detailed instruction sheet including clear images of the exercise procedures, instructions and warning signs will be provided to the participants. (Available in English, Sinhala and Tamil). The compliance of the participants will be monitored by regular video call sessions with each subject and if that facility is not accessible by them, regular voice calls will be made. Subjects will be advised to maintain an exercise diary and bring it to their monthly MOH clinic. Principle investigator will review the exercises at monthly MOH clinic. Adherence to the exercise program will be encouraged by the principal investigator who supervises the exercise sessions.
Inclusion criteria
Pregnant women age between 18 to 35 years Pregnant women in their first pregnancy. Pregnant women in their second trimester. Those who are willing to comply with all study procedures and be available for the duration of the study.
Exclusion criteria
History of high blood pressure, restrictive lung disease, chronic medical illnesses, (cancer, renal, endocrine, neurologic, infectious, or cardiovascular diseases) Previously diagnosed sleep disorders, stress disorders, panic attacks or psychiatric disorders currently on treatment. Known cases of severe cognitive, physical, visual and communication impairments Persistent vaginal bleeding after 12 weeks History of miscarriage within last 12 months Multiple gestation at risk for premature labour Diseases related to the reproductive system such as placenta previa Participants of a structured exercise programme within last 6 months Extreme obesity or underweight ( 12>BMI>30 )
Primary outcome(s)
1.
Perceived Stress Scale will be used to assess the stress level of the participants. |
[ First day before commencing the intervention and after completion of 8 weeks of intervention Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama. ] |
2.
Pittsburg Sleep Quality index will be used to assess the sleep quality of the participants. |
[ First day before commencing the intervention and after completion of 8 weeks of intervention Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama. ] |
3.
Six-minute Walk test will be used to assess the cardiovascular fitness of the participants. |
[ First day before commencing the intervention and after completion of 8 weeks of intervention Control group: on the first day and after 8 weeks of only routine maternal care at MOH Ragama. ] |
Secondary outcome(s)
1.
None |
[ None ] |
Target number/sample size
70 (35 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-06-08
Anticipated end date
2025-09-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
N/A
Status
Approved
Date of Approval
2025-02-24
Approval number
2024/EC/48
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of medicine, University of Peradeniya |
Institutional Address: | Faculty of Medicine, University of Peradeniya. |
Telephone: | 0812396361 |
Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
U.T.Nawinnna
Post graduate student (MSc in Physiotherapy) of Faculty of Allied Health sciences,University of Peradeniya
Department of Physiotherapy
Faculty of Allied Health Sciences,
University of Peradeniya,
Augusta Hill,
Sri Amarawansa mawatha,
Peradeniya
0813999623
0712773977
thamali.nawinna@gmail.com
ahs.pdn.ac.lk
Contact Person for Public Queries
Dr Esther Liyanage
Head of the department
Department of Physiotherapy
Faculty of Allied Health Sciences,
University of Peradeniya,
Augusta Hill,
Sri Amarawansa mawatha,
Peradeniya
0813999623
0716789288
estherl@ahs.ac.lk
ahs.pdn.ac.lk
Primary study sponsor/organization
Medical Officer of Health
2WGC+X35, Ragama
0112 958 035
mohragama@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results