Postnatal DepressionNCT05891717
Comparative Effect of Training on Postpartum Depression
A study testing Resistance training and Flexibility training in people with Postnatal Depression and Self Efficacy, run by Riphah International University at 1 site in Pakistan.
Trial summary
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. This study will be a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postnatal Depression, Self Efficacy
- What is being tested?
- Resistance training and Flexibility training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2022to 1 Aug 2023
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 to 40
- 6 weeks to 8 months postpartum females
- primiparous or multiparous postnatal wome
Who cannot join
- Family history of depression
- Hospitalization for a psychiatric disorder in the past 6 months; and currently receiving antidepressant medication or psychotherapy for depression.
- Pregnant women
- Women with psychiatric diagnoses other than depression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Flexibility and Resistance Training on Self-efficacy, Symptoms and Maternal Quality of Life in Postpartum Depression
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness.
This study will be a randomized clinical trial. It divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. Data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. In this study Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) will be used as subjective measurements.
Read the detailed description
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Postpartum depression typically begins within the first two to three days after delivery and may last for up to several weeks or months. Activity and mobility are an integral part of human life that is manifested in a special way in each period. Postpartum life has caused lack of movement, the risk factor of depression and difficulty in maternal life. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. A logical approach to treatment, therefore, would be to improve postpartum life. Flexibility exercises are not just for gymnasts, but rather for everyone. Along with the better range of motion, it decreases risks of injuries, increases blood supply and nutrients to joints, reduces muscular tension and help to improve quality of life.
This study will be a randomized clinical trial. Subjects meeting the predetermined inclusion and exclusion criteria will divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. After informed consents were obtained, data will collect. After taking written consent from participants who meet the inclusion criteria, data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. Pre-treatment assessment and Post treatment reading will be done using Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) as subjective measurements. Recorded values will be analyzed for any change using SPSs version 25.
- Conditions
- Postnatal Depression, Self Efficacy
- Being tested
- Resistance training, Flexibility training
- Keywords
- Strength training, Functional status, Self efficacy
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Twice per week for 8 weeks. Total 16 sessions will given.
Flexibility trainingOther
Twice per week for 8 weeks. Total 16 sessions will given.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Group A will receive resistance training. Twice per week for 8 weeks. Total 16 sessions will given. Receives: Other: Resistance training |
| Flexibility training | Active comparator | Group B will receive flexibility training. Twice per week for 8 weeks. Total 16 sessions will given. Receives: Other: Flexibility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise self efficacy
A 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults; specifically the ability to continue to exercise despite barriers. The participant is asked about their confidence level, on a scale from 0 (not confident) to 10 (very confident)
Measured: 8 weeks
Epidemiological studies Depression scale
The Center for Epidemiologic Studies Depression Scale (CES-D) is a brief self-report questionnaire developed in 1977 by Laurie Radloff to measure depressive symptoms severity in the general population
Measured: 8 weeks
MAPP-QOL ( Maternal Postpartum Quality Life Questionnaire)
Maternal Postpartum Quality of Life (MAPP-QOL) questionnaire, which is a self-administered instrument that measures quality of life during the early postnatal period. 12 The MAPP-QOL is composed of five domains and demonstrates convergent validity with measures of life satisfaction and mood states.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start20 Nov 2022
- Primary completion13 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.Phill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891717
- Sponsor's protocol ID
- REC/RCR & AHS/23/0509
- Status last verified
- Dec 2023
- First submitted
- 18 Apr 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Posmontier B. Functional status outcomes in mothers with and without postpartum depression. J Midwifery Womens Health. 2008 Jul-Aug;53(4):310-8. doi: 10.1016/j.jmwh.2008.02.016.
PubMed 18586183Papamarkou M, Sarafis P, Kaite CP, Malliarou M, Tsounis A, Niakas D. Investigation of the association between quality of life and depressive symptoms during postpartum period: a correlational study. BMC Womens Health. 2017 Nov 21;17(1):115. doi: 10.1186/s12905-017-0473-0.
PubMed 29162087Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
PubMed 31343601Hooker QL, Lanier VM, Roles K, van Dillen LR. Motor skill training versus strength and flexibility exercise in people with chronic low back pain: Preplanned analysis of effects on kinematics during a functional activity. Clin Biomech (Bristol). 2022 Feb;92:105570. doi: 10.1016/j.clinbiomech.2021.105570. Epub 2022 Jan 3.
PubMed 35045374Mirghafourvand M, Bagherinia M. Relationship between maternal self-efficacy and functional status four months after delivery in Iranian primiparous women. J Psychosom Obstet Gynaecol. 2018 Dec;39(4):321-328. doi: 10.1080/0167482X.2017.1394290. Epub 2017 Nov 2.
PubMed 29094655
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Flexibility and Resistance Training on Self-efficacy, Symptoms and Maternal Quality of Life in Postpartum Depression
- ClinicalTrials.gov ID
- NCT05891717
- Acronym / sponsor ID
- REC/RCR & AHS/23/0509
- Conditions
- Postnatal Depression, Self Efficacy
- Keywords
- Strength training, Functional status, Self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 7 Jun 2023 (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.
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness.
This study will be a randomized clinical trial. It divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. Data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. In this study Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) will be used as subjective measurements.
Detailed description
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Postpartum depression typically begins within the first two to three days after delivery and may last for up to several weeks or months. Activity and mobility are an integral part of human life that is manifested in a special way in each period. Postpartum life has caused lack of movement, the risk factor of depression and difficulty in maternal life. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. A logical approach to treatment, therefore, would be to improve postpartum life. Flexibility exercises are not just for gymnasts, but rather for everyone. Along with the better range of motion, it decreases risks of injuries, increases blood supply and nutrients to joints, reduces muscular tension and help to improve quality of life.
This study will be a randomized clinical trial. Subjects meeting the predetermined inclusion and exclusion criteria will divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. After informed consents were obtained, data will collect. After taking written consent from participants who meet the inclusion criteria, data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. Pre-treatment assessment and Post treatment reading will be done using Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) as subjective measurements. Recorded values will be analyzed for any change using SPSs version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingGroup A will receive resistance training. Twice per week for 8 weeks. Total 16 sessions will given. |
| Flexibility training | Active comparator | Other: Flexibility trainingGroup B will receive flexibility training. Twice per week for 8 weeks. Total 16 sessions will given. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20 to 40
- 6 weeks to 8 months postpartum females
- primiparous or multiparous postnatal wome
Key exclusion criteria (4 listed)
- Family history of depression
- Hospitalization for a psychiatric disorder in the past 6 months; and currently receiving antidepressant medication or psychotherapy for depression.
- Pregnant women
- Women with psychiatric diagnoses other than depression
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 |
|---|---|---|
| Resistance trainingTwice per week for 8 weeks. Total 16 sessions will given. | Other | Resistance training |
| Flexibility trainingTwice per week for 8 weeks. Total 16 sessions will given. | Other | Flexibility training |
Primary outcome
Exercise self efficacy
Time frame: 8 weeks
A 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults; specifically the ability to continue to exercise despite barriers. The participant is asked about their confidence level, on a scale from 0 (not confident) to 10 (very confident)
Epidemiological studies Depression scale
Time frame: 8 weeks
The Center for Epidemiologic Studies Depression Scale (CES-D) is a brief self-report questionnaire developed in 1977 by Laurie Radloff to measure depressive symptoms severity in the general population
MAPP-QOL ( Maternal Postpartum Quality Life Questionnaire)
Time frame: 8 weeks
Maternal Postpartum Quality of Life (MAPP-QOL) questionnaire, which is a self-administered instrument that measures quality of life during the early postnatal period. 12 The MAPP-QOL is composed of five domains and demonstrates convergent validity with measures of life satisfaction and mood states.
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 27 Dec 2023.
- Background: PubMed 18586183Posmontier B. Functional status outcomes in mothers with and without postpartum depression. J Midwifery Womens Health. 2008 Jul-Aug;53(4):310-8. doi: 10.1016/j.jmwh.2008.02.016.
- Background: PubMed 29162087Papamarkou M, Sarafis P, Kaite CP, Malliarou M, Tsounis A, Niakas D. Investigation of the association between quality of life and depressive symptoms during postpartum period: a correlational study. BMC Womens Health. 2017 Nov 21;17(1):115. doi: 10.1186/s12905-017-0473-0.
- Background: PubMed 31343601Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- Background: PubMed 35045374Hooker QL, Lanier VM, Roles K, van Dillen LR. Motor skill training versus strength and flexibility exercise in people with chronic low back pain: Preplanned analysis of effects on kinematics during a functional activity. Clin Biomech (Bristol). 2022 Feb;92:105570. doi: 10.1016/j.clinbiomech.2021.105570. Epub 2022 Jan 3.
- Background: PubMed 29094655Mirghafourvand M, Bagherinia M. Relationship between maternal self-efficacy and functional status four months after delivery in Iranian primiparous women. J Psychosom Obstet Gynaecol. 2018 Dec;39(4):321-328. doi: 10.1080/0167482X.2017.1394290. Epub 2017 Nov 2.
- Individual participant dataSharing planned: No
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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.
Sabiha Arshad, M.Phill principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Flexibility training in people with Postnatal Depression and Self Efficacy, run by Riphah International University 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 3 inclusion and 4 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 27 Dec 2023. 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?
Exercise self efficacy (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT05891717, which also lists 5 linked publications.
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 27 Dec 2023.