Post Partum DepressionNCT04813341
Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression
A study testing Pilates training and Aerobic Training in people with Post Partum Depression, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Pilates training and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Sep 2020to 30 Aug 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Vaginal delivery
- Singleton pregnancy
Who cannot join
- Caesarean delivery
- Vacuum-assisted delivery
- Sexually Transmitted Diseases
- Menopause females
- Any condition regarding Obstetrics \& Gynecology
- Any physical or mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mat Pilates and Aerobic Training on Fatigue Levels of Postpartum Females
The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females
Read the detailed description
The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females. In this study, the researcher will also compare the effects of Mat Pilates and Aerobic training on fatigue and depression levels among postpartum females.
- Conditions
- Post Partum Depression
- Being tested
- Pilates training, Aerobic Training
- Keywords
- Depression, Fatigue, low intensity Aerobic training, Mat-Pilates
- Medical subject headings
- Depression, Postpartum, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates trainingOther
Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles. The participant will be instructed to perform 3-5 repetitions of these movements at the start, and to add two more repetitions for each movement every week until the end of the intervention.
Aerobic TrainingOther
WALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week
SITTING EERCISES:
Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times
BALANCE EXERCISES:
Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week.
Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week.
| Study group | Role | What they receive |
|---|---|---|
| Pilates training | Experimental | Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles Receives: Other: Pilates training |
| Aerobic Training | Active comparator | WALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week
SITTING EERCISES:
Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times
BALANCE EXERCISES:
Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week.
Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week. Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Fatigue Inventory
The MFI-20 is a self-report of 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. By limiting the length of questionnaire, developers hoped to accommodate those individuals who might find larger measures especially tiring in obtaining multiple facets of fatigue. The internal consistency of MFI-20 is ranging from .53 to .93.
Measured: 6 weeks
Edinburgh Postnatal Depression Scale
EPDS developed for screening postpartum women in outpatient, home-visiting settings or at 6-8-week postpartum examination. It consists of 10 questions for postnatal period which reliably identifies women at risk of developing depression. The sensitivity and specificity of EPDS is 70-85%.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start18 Sep 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah college of rehabilitation and allied health sciences - Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813341
- Sponsor's protocol ID
- REC/00844 Rida Fatima
- Status last verified
- Sep 2021
- First submitted
- 22 Mar 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mat Pilates and Aerobic Training on Fatigue Levels of Postpartum Females
- ClinicalTrials.gov ID
- NCT04813341
- Acronym / sponsor ID
- REC/00844 Rida Fatima
- Conditions
- Post Partum Depression
- Keywords
- Depression, Fatigue, low intensity Aerobic training, Mat-Pilates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 24 Mar 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.
The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females
Detailed description
The aim is to see fatigue and depression levels in postpartum females and to evaluate ho two well-known exercises, Mat Pilates and Aerobic training can help to reduce the fatigue levels in postpartum females. In this study, the researcher will also compare the effects of Mat Pilates and Aerobic training on fatigue and depression levels among postpartum females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates training | Experimental | Other: Pilates trainingBridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles |
| Aerobic Training | Active comparator | Other: Aerobic TrainingWALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week SITTING EERCISES: Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times BALANCE EXERCISES: Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week. Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Vaginal delivery
- Singleton pregnancy
Key exclusion criteria (6 listed)
- Caesarean delivery
- Vacuum-assisted delivery
- Sexually Transmitted Diseases
- Menopause females
- Any condition regarding Obstetrics \& Gynecology
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 |
|---|---|---|
| Pilates trainingBridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles. The participant will be instructed to perform 3-5 repetitions of these movements at the start, and to add two more repetitions for each movement every week until the end of the intervention. | Other | Pilates training |
| Aerobic TrainingWALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week SITTING EERCISES: Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times BALANCE EXERCISES: Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week. Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week. | Other | Aerobic Training |
Primary outcome
Multidimensional Fatigue Inventory
Time frame: 6 weeks
The MFI-20 is a self-report of 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity and mental fatigue. By limiting the length of questionnaire, developers hoped to accommodate those individuals who might find larger measures especially tiring in obtaining multiple facets of fatigue. The internal consistency of MFI-20 is ranging from .53 to .93.
Edinburgh Postnatal Depression Scale
Time frame: 6 weeks
EPDS developed for screening postpartum women in outpatient, home-visiting settings or at 6-8-week postpartum examination. It consists of 10 questions for postnatal period which reliably identifies women at risk of developing depression. The sensitivity and specificity of EPDS is 70-85%.
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 23 Sep 2021.
- 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.
Anam Aftab, Phd* principal investigator
Riphah college of rehabilitation and allied health sciences - Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates training and Aerobic Training in people with Post Partum Depression, 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 2 inclusion and 6 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 23 Sep 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?
Multidimensional Fatigue Inventory (time frame: 6 weeks). The study lists 2 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 23 Sep 2021.