Back to resultsEffects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function
Primary Purpose
Pregnancy Related
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
hydrotherapy
foot exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related focused on measuring foot, exercises, hydrotherapy, pedal, edema lower extremity, antenatal, women
Eligibility Criteria
Inclusion Criteria: Normal singleton pregnancy Gestational age 30-40 weeks Pitting edema in feet Exclusion Criteria: presence of any under lying disease e.g. Diabetes, Hypertension, High risk pregnancy Any wound or skin lesion
Sites / Locations
- Sajida Khalil Hospital GujratRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Foot exercise with hydrotherapy
Foot exercise
Arm Description
Hydrotherapy will be performed by immersing the women's foot in a container filled with 3 liters water with a temperature of 30-32°C. The water level must cover the women's feet up to ankle. During the immersion the therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each. The duration of water immersion session will be (30 min) for 5 consecutive days
The therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each
Outcomes
Primary Outcome Measures
Figure of 8 Method
The figure of 8 method uses landmarks on the foot and ankle to measure the circumference of ankle in centimeters.
the point midway over the anterior ankle between the tibialis anterior tendon and lateral malleolus,
the navicular tuberosity,
the base of the fifth metatarsal, and
the inferior tip of the medial malleolus
Lower Extremity Functional Scale
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used to evaluate the functional status of lower limb
Secondary Outcome Measures
Full Information
NCT ID
NCT05777538
First Posted
March 8, 2023
Last Updated
March 8, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05777538
Brief Title
Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function
Official Title
Effects of Foot Exercises With and Without Hydrotherapy on Pedal Edema & Lower Extremity Function in Antenatal Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema & lower extremity function in antenatal women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
foot, exercises, hydrotherapy, pedal, edema lower extremity, antenatal, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Foot exercise with hydrotherapy
Arm Type
Experimental
Arm Description
Hydrotherapy will be performed by immersing the women's foot in a container filled with 3 liters water with a temperature of 30-32°C. The water level must cover the women's feet up to ankle. During the immersion the therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each. The duration of water immersion session will be (30 min) for 5 consecutive days
Arm Title
Foot exercise
Arm Type
Active Comparator
Arm Description
The therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each
Intervention Type
Other
Intervention Name(s)
hydrotherapy
Intervention Description
Hydrotherapy will be performed by immersing the women's foot in a container filled with 3 liters water with a temperature of 30-32°C. The water level must cover the women's feet up to ankle. During the immersion the therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each. The duration of water immersion session will be (30 min) for 5 consecutive days.
Intervention Type
Other
Intervention Name(s)
foot exercises
Intervention Description
The therapist will ask the women to perform exercise with legs being fully supported, then alternatively stretch and flex the ankle for 30 times. which will be followed by circling each foot at ankle in clock wise and anticlock wise direction, 30 times each.
Primary Outcome Measure Information:
Title
Figure of 8 Method
Description
The figure of 8 method uses landmarks on the foot and ankle to measure the circumference of ankle in centimeters.
the point midway over the anterior ankle between the tibialis anterior tendon and lateral malleolus,
the navicular tuberosity,
the base of the fifth metatarsal, and
the inferior tip of the medial malleolus
Time Frame
8th week
Title
Lower Extremity Functional Scale
Description
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used to evaluate the functional status of lower limb
Time Frame
8th week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal singleton pregnancy
Gestational age 30-40 weeks
Pitting edema in feet
Exclusion Criteria:
presence of any under lying disease e.g.
Diabetes,
Hypertension,
High risk pregnancy
Any wound or skin lesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
imran amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hina gul, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sajida Khalil Hospital Gujrat
City
Gujrat
State/Province
Punjab
ZIP/Postal Code
05499
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hina gul, MSOMPT
Phone
03214979172
Email
hina.gul@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Shahar Bano Mohammed, DPT
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
.MACWAN KR, Savaliya PK. Effectiveness of Foot Exercise and Epsom Salt Water on Reduction of Foot Oedema among Antenatal Mothers. Journal of Clinical & Diagnostic Research. 2021;15
Results Reference
background
Citation
Talbot L, Maclennan K. Physiology of pregnancy. Anaesthesia & Intensive Care Medicine. 2016;17(7):341-5
Results Reference
background
Citation
Patola A, Tridiyawati F. The Effectiveness of Soaking the Feet in Salt Water to Reduce the Degree of Edema in Pregnant Women Trimester III. Jurnal Keperawatan Komprehensif (Comprehensive Nursing Journal). 2022;8
Results Reference
background
Citation
Ahmed AH, Ismail NIAA, Hassan NMM. Effect of effleurage massage versus water immersion with exercise on physiological foot edema among primigravidae. Egypt J Health Care. 2021;12(2):56-345
Results Reference
background
Learn more about this trial
Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function
We'll reach out to this number within 24 hrs