Effects of Foot Exercises and Hydrotherapy on Pedal Edema & Lower Extremity Function

March 4, 2024 updated by: Riphah International University

Effects of Foot Exercises With and Without Hydrotherapy on Pedal Edema & Lower Extremity Function in Antenatal Women

To determine the Effects of foot exercises with and without hydrotherapy on pedal Edema & lower extremity function in antenatal women.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Gujrat, Punjab, Pakistan, 05499
        • Sajida Khalil Hospital Gujrat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot exercise with hydrotherapy
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
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.
Active Comparator: Foot exercise
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Figure of 8 Method
Time Frame: 8th week

The figure of 8 method uses landmarks on the foot and ankle to measure the circumference of ankle in centimeters.

  1. the point midway over the anterior ankle between the tibialis anterior tendon and lateral malleolus,
  2. the navicular tuberosity,
  3. the base of the fifth metatarsal, and
  4. the inferior tip of the medial malleolus
8th week
Lower Extremity Functional Scale
Time Frame: 8th week
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
8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: hina gul, MSOMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • .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
  • Talbot L, Maclennan K. Physiology of pregnancy. Anaesthesia & Intensive Care Medicine. 2016;17(7):341-5
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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