- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04813341
Effectiveness of Mat Pilates and Aerobic Training on Fatigue and Depression
Effectiveness of Mat Pilates and Aerobic Training on Fatigue Levels of Postpartum Females
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Jhelum, Punjab, Pakistan, 50430
- Anmol Hospital Phalia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Vaginal delivery
- Singleton pregnancy
Exclusion Criteria:
- Caesarean delivery
- Vacuum-assisted delivery
- Sexually Transmitted Diseases
- Menopause females
- Any condition regarding Obstetrics & Gynecology
- Any physical or mental illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Pilates training
Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles
|
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.
|
|
ACTIVE_COMPARATOR: Aerobic Training
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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%.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00844 Rida Fatima
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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