NCT05777538

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 8, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

footexerciseshydrotherapypedaledema lower extremityantenatalwomen

Outcome Measures

Primary Outcomes (2)

  • Figure of 8 Method

    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

    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

Study Arms (2)

Foot exercise with hydrotherapy

EXPERIMENTAL

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

Other: hydrotherapyOther: foot exercises

Foot exercise

ACTIVE COMPARATOR

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

Other: foot exercises

Interventions

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.

Foot exercise with hydrotherapy

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.

Foot exerciseFoot exercise with hydrotherapy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal singleton pregnancy
  • Gestational age 30-40 weeks
  • Pitting edema in feet

You may not qualify if:

  • presence of any under lying disease e.g.
  • Diabetes,
  • Hypertension,
  • High risk pregnancy
  • Any wound or skin lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sajida Khalil Hospital Gujrat

Gujrat, Punjab Province, 05499, Pakistan

Location

Related Publications (4)

  • .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

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hina gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 21, 2023

Study Start

October 1, 2022

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations