NCT06271798

Brief Summary

The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal 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 Feb 2024

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

First Submitted

Initial submission to the registry

February 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

February 15, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

Resistive ExercisesAerobic ExercisesVaricose VeinsPostmenopausal Women

Outcome Measures

Primary Outcomes (1)

  • Peak popliteal vein velocity

    It will be assessed by Doppler ultrasound scan for each woman in both groups before and after treatment.

    6 weeks

Secondary Outcomes (3)

  • Visual analogue scale

    6 weeks

  • Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20)

    6 weeks

  • 6-minute. walk test

    6 weeks

Study Arms (2)

Group A (Resistive exercise group):

EXPERIMENTAL

They will receive life style modification advice, in addition to performing resistive exercise three times per week for six weeks.

Other: Life style modification adviceOther: Resistive exercise

Group B (Aerobic exercise group):

EXPERIMENTAL

They will receive the same life style modification advice, in addition to performing aerobic exercise three times per week for six weeks.

Other: Life style modification adviceOther: Aerobic exercises

Interventions

The lifestyle modification advice involves several key elements: reducing daily standing periods, avoiding excessive flexion of the knee joint during sitting, weight reduction, addressing cardio-respiratory conditions, incorporating venotonic agents, and utilizing below-knee elastic compression devices. These measures collectively aim to mitigate the development and progression of varicose veins, potentially preventing complications such as deep venous thrombosis and improving overall circulatory health.

Group A (Resistive exercise group):Group B (Aerobic exercise group):

Participants in group A will perform resistive exercise. The patients will be instructed to do seated toe raises exercise or standing toe raise exercise. The exercise will be performed for 30 minutes, three times per week for six weeks.

Group A (Resistive exercise group):

Participants in group B will perform aerobic exercise. Each session will begin with 10 min of low-intensity treadmill walking for a warm-up. The subsequent aerobic component will involve incline treadmill walking for 20 min at a perceived exertion of 6-7 (i.e., somewhat hard) on Borg's 3-10 scale followed by 10 min of low-intensity treadmill walking for cool down. The exercise will be performed for 30 minutes, three times per week for six weeks.

Group B (Aerobic exercise group):

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All women suffering from varicose veins.
  • Their age will range from 50 to 65 years.
  • Their body mass index will range from 25 to 29.9 kg/m2.
  • Voluntary acceptance of participation in the study.

You may not qualify if:

  • Had history of serious vascular disease as deep venous thrombosis.
  • Sensory deficient
  • Any dermatological condition that interferes with the procedure.
  • Any musculoskeletal or neurological disorders.
  • Acute or healed ulcer wounds.
  • Any heart disease or pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Soheir Mahmoud Elkosery, PhD

    Department of Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

February 20, 2024

Primary Completion

April 5, 2024

Study Completion

May 20, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations